Forehead-cooling device × Absolute latency to persistent sleep: Null co-primary findings and separate supportive measures

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich existing absolute-latency claim is being presented?Required	The selected claim is improved absolute latency to persistent sleep, with subclaim grade D and a note that P=.092 was null. Subclaim score, status and axes are absent and are retained separately from parent D with 28 points and its axes. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Separate the selected subclaim wording and original grade from parent context	Material needed: The selected endpoint's exact definition and effect of interest, and review of the claim boundary. Parent scores are not used to fill subclaim scores. Only the need for material or research is recorded; no new retrieval or research is performed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhich population with insomnia produced these findings?Required	The original material records randomization of 106 adults with diagnosed insomnia to active or sham devices. Age range, diagnostic details, comorbidities, sleep medication and other exposure details are not established in the stored summary. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Diagnosed adults, eligibility and concurrent exposures	Material needed: Original eligibility and exclusion criteria, diagnostic criteria, baseline characteristics, medication and concurrent treatment, and adherence. Application is not extended to every sleep problem. Only the need for material or research is recorded; no new retrieval or research is performed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionIs the active device equivalent to an ordinary cold pack?Required	The original intervention was a frontal thermal-therapy device regulating forehead temperature at 14–16°C. The original statement that it is not equivalent to an ordinary cold pack is retained. Temperature identifies the study device and is not an implementation instruction. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Study device and actual active intervention	Material needed: Actual device model and settings, exposure, duration of use, adherence and product-support material. No new equivalence with other cooling or sleep devices or instructions for use are produced. Only the need for material or research is recorded; no new retrieval or research is performed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhat were the actual sham-device control conditions?Required	The original design was prospective, randomized and sham-controlled, and the classification information indicates sham intervention. Actual sham temperature, operation, sensation, successful blinding and concurrent-treatment details are not established in the summary. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Sham device, measurement and concurrent treatment	Material needed: Original active and sham implementation, allocation concealment, blinding, sensation and expectations, and concurrent exposures in both groups. Sham is not substituted with no intervention or an ordinary cold pack. Only the need for material or research is recorded; no new retrieval or research is performed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionHow many nights were used to assess efficacy?Required	The original material records two-night assessment. Baseline measurement nights, adaptation nights, night-specific findings, averaging and follow-up after exposure are not verified in detail. Two nights are not added as separate trials or participant counts. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Measurement nights, duration and repeated measurements	Material needed: Actual PSG measurement schedules, baseline and treatment nights, repeated-measures models and long-term follow-up. No new total night count or observation time is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhat exactly defines latency to persistent sleep?Required	The original co-primary endpoints were absolute latency to persistent sleep and absolute sleep efficiency. PSG rules for persistent sleep, timing definitions, scoring, night-specific aggregation and analysis timing are not established from the stored summary alone. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	PSG absolute latency to persistent sleep	Material needed: Original PSG LPS definitions, scoring blinding, stage and continuity rules, measurement times and analysis units. Subjective sleep onset or entry into a sleep stage is not substituted for LPS. Only the need for material or research is recorded; no new retrieval or research is performed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionAre absolute results distinguished from relative changes?Required	The original material distinguishes null co-primary absolute LPS from favorable relative latency to persistent sleep in supportive analyses. Absolute values and relative changes are not combined as the same estimand or success criterion. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Effects of interest for absolute LPS and relative sleep-latency change	Material needed: Original formulas, denominators, analysis models, prespecified hierarchy and endpoint-specific effects and CIs for absolute values, change from baseline and relative change. No new conversion is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhat are the selected absolute-LPS between-group effect and uncertainty?Required	The between-group difference in absolute latency to persistent sleep was -7.9 minutes (95% CI -18.4 to 2.6), P=.092, and the original verdict was null. This is not rejudged as positive, an exactly zero effect, equivalence or noninferiority. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Original LPS between-group difference, CI and P value	Material needed: Original effect of interest, analysis population, models, CI and P calculations, and separate confirmatory material. No new effect, CI, P value or quantitative example is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionIs the co-primary sleep-efficiency result separated from LPS?Required	The absolute sleep-efficiency difference was +0.5 percentage points (95% CI -3.4 to 4.5), P=.759. This is another endpoint in the same 106-person, two-night trial, not the absolute-LPS effect or separate independent replication. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	The other co-primary PSG endpoint	Material needed: Sleep-efficiency calculations, denominators, models, co-primary specifications and endpoint-specific analysis material. Percentage points are not converted into minutes or event effects. Only the need for material or research is recorded; no new retrieval or research is performed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionHow do prespecified co-primary success criteria relate to supportive findings?Required	The original material states that both prespecified co-primary PSG endpoints were null and favorable supportive findings do not replace these failures. Prespecification is retained as an original statement, not certification of new reading of the registration or SAP. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Failure of both co-primary endpoints and prespecified plans	Material needed: Registration, protocol and SAP versions and dates, co-primary success rules, multiplicity plans and amendment history. No new trial-success or grade judgment. Only the need for material or research is recorded; no new retrieval or research is performed.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionWere actual group-specific absolute latency values provided?Required	The stored summary provides the absolute-LPS between-group difference of -7.9 minutes, but not detailed baseline and final group means or variance, night-specific values or changes. Group values are not reverse-calculated from the between-group difference. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Baseline and final absolute values by group versus between-group differences	Material needed: Baseline and final LPS values by group and measurement night, variance, analysis populations, models and missingness. No new group values, rates or changes are calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionWhat is the positive relative-latency signal?Supplementary	The original counterview records a favorable direction for relative latency to persistent sleep. Individual quantitative effects, CIs, P values and models are absent from the summary; absolute-LPS P=.092 is not copied as the value of this supportive finding. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Relative-latency supportive analysis versus the absolute primary result	Material needed: Original tables, definitions, denominators, effects and CIs, prespecified hierarchy and multiplicity plans for that relative measure. The signal is not promoted into established long-term efficacy. Only the need for material or research is recorded; no new retrieval or research is performed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionIs latency to sleep stages 1 and 2 the same as latency to persistent sleep?Supplementary	The original statement describes favorable latencies to stages 1 and 2 in supportive analyses. These are not the same findings as absolute latency to persistent sleep or sleep efficiency. Individual stage effects, CIs and P values are not newly filled in. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Distinguish supportive measures for each sleep stage	Material needed: Stage-specific PSG definitions, original findings, denominators, measurement nights, primary and supportive hierarchy and multiplicity plans. Stage-specific findings are not added as new participants or trials. Only the need for material or research is recorded; no new retrieval or research is performed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionIs material available to assess selection and multiplicity of supportive findings?Required	The original material explains that foregrounding favorable supportive measures can obscure the core failures. The number of all supportive endpoints, testing plans and selective reporting are not newly established from this summary. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Retain positive supportive measures together with failed primary findings	Material needed: Complete endpoint lists, registration and SAP, amendment history, all findings, multiple-testing plans and comparisons with the paper. No new formal RoB assessment or rejudging. Only the need for material or research is recorded; no new retrieval or research is performed.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionDo 106 participants form the analysis denominator for every endpoint?Required	The original material records randomization of 106 adults and assessment over two nights. Group-specific allocation, analysis and completion, valid PSG data by endpoint, withdrawals and missingness are not established in the stored summary. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Allocation, analysis, completion, withdrawal and night-specific missingness	Material needed: Group-specific flow diagrams, analysis populations, missing data by night and endpoint, withdrawal reasons and handling. No new 53/53 allocation, completion count, missing-data count or rate, or total night count is created. Only the need for material or research is recorded; no new retrieval or research is performed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionAre within-group improvements separated from the between-group effect of interest?Required	The original reader answer gives between-group differences, while supportive relative-latency change is separate. Detailed natural change in each group, sham responses, models and adjustment are absent; within-group improvement is not transferred into an additional active-treatment effect. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Active-versus-sham comparison and change from baseline	Material needed: Original baseline and final group values, prespecified estimands, repeated-measures and adjustment models, concurrent exposures and sham responses. No new difference or ratio is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
17	Partly verified	Full text not readStored summary read	N17 · Harm-information gaps supplementing the efficacy tableWhat is the scope of two-night harms and tolerability statements?Supplementary	The original material records broadly similar adverse-event patterns with the sham device over two nights and reports of headache and other events. Group-specific event counts, severity, attribution, discontinuation and exposure denominators are not verified in detail. Similar patterns are not converted into absence of harms or equivalence. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Short-term AE patterns versus long-term safety	Material needed: AE collection methods, group-specific exposure and harm denominators, headache and other events, discontinuation, attribution and long-term harms. No new harm rates or device-care or implementation instructions. Only the need for material or research is recorded; no new retrieval or research is performed.
18	Unverified	Full text not readStored summary read	N18 · Harm-information gaps supplementing the efficacy tableDo findings extend to long-term sleep efficacy and safety?Supplementary	The original material explains that separate trials are needed for long-term efficacy and safety. Some supportive sleep-latency signals are not extended into long-term insomnia improvement, daytime function, replacement of treatment or long-term safety. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Two-night effects versus persistence and long-term outcomes	Material needed: Longer active-versus-sham confirmatory trials with prespecified absolute LPS, clinical sleep and function, long-term exposure and harms, discontinuation and recurrence. No device, cooling, sleep-care or treatment-replacement implementation instructions are provided. Only the need for material or research is recorded; no new retrieval or research is performed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWhat materials were actually read in this work?Required	The complete parent summary was read for production and preserved in its original form. Summary reading in material entries refers to the stored summary; external abstract, full text, registration, protocol and SAP were not read. The presence of a URL or PMCID is not promoted into external reading. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Stored summary and access status of external material	Material needed: Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing. Only the need for material or research is recorded; no new retrieval or research is performed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionWhat does the registration number establish?Required	NCT01966211 appears in the original evidence and citation. The identifier is retained; there has been no new reading or verification of registration content, versions, timing, results disclosure or agreement with plans. An official registration URL is not guessed. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Registration identifier in references and evidence versus actual registration reading	Material needed: Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration. Only the need for material or research is recorded; no new retrieval or research is performed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionWere the protocol and SAP acquired?Required	Specific protocol and SAP URLs, original text, versions and dates were not newly acquired or read. Parent statements about prespecified endpoints and historical cross-checking are retained as history and are not described as new content review. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Separate entries for prespecified plans, amendments and analysis material	Material needed: Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes. Only the need for material or research is recorded; no new retrieval or research is performed.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre funding, support, authors and research involvement separated?Required	Original funding records list NIH and NHLBI support, Ebb Therapeutics device and study involvement, and a company founder and executive as author. Public support is distinguished from company device support, study involvement and employee or executive authors. Separate amounts of company funding and detailed analysis and design roles are not established. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Four categories of company involvement versus public and academic support	Material needed: Separate original funding sources, food or device support, employee and executive authors, design, analysis and data control, and conflicts of interest. Original independence axes are not used as new independence certification. Only the need for material or research is recorded; no new retrieval or research is performed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAre unmeasured outcomes, unverified details and null results distinguished?Required	The original null absolute-LPS P=.092, favorable supportive signals and unverified external details are different states. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Reasons for question-specific result and access statuses	Material needed: Material to establish direct measurement, original tables, analysis plans and material access. Unread material is not substituted for unreported findings, zero studies or zero effects. Only the need for material or research is recorded; no new retrieval or research is performed.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre reports, trials, people, measurements and related sheets separated?Required	Parent verdict 2982 and the latency and sleep-efficiency sheets share the same Roth2018 report and 106-person, two-night trial context. The same people, groups, nights, endpoints, supportive analyses, references and related sheets are not added as new independent trials or participants. One current report link is not a certified count of unique trials or participants. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Reference linkage and meaning without double counting	Material needed: Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded. Only the need for material or research is recorded; no new retrieval or research is performed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionIs there evidence of separate independent replication?Supplementary	Original parent replication and independence axes R1/I0 are retained. Reuse of the current reference and related sheets is not certified as new independent efficacy or harm replication. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Report identity versus independent confirmation	Material needed: Reports with separate prespecified plans, populations, interventions and controls, direct endpoints, follow-up, effects and CIs, and funding and author relationships appropriate to the question. No new search or independence adjudication. Only the need for material or research is recorded; no new retrieval or research is performed.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionAre subclaim grades separated from parent scores and axes?Required	The selected subclaim grade and note are retained in their original form, and absent score, status and axes remain unrecorded. Parent D with 28 points, safety and axes are parent context. No new score, grade or official RoB2 or GRADE certification is produced. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Selected-record absences versus the parent verdict	Material needed: Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values. Only the need for material or research is recorded; no new retrieval or research is performed.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionAre Korean, English and classification scopes preserved as the same original record?Required	The complete parent Korean and English texts, classification information, evidence and citations, and selected subclaim wording, grade and note are preserved in the complete stored summary. This is not a new comparison with the English original paper or another verdict. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Original Korean and English texts and structured fields	Material needed: Material for review of differences in original languages, selected and parent claims, terminology, visits and measurement definitions. General wording is not extended into new clinical proof. Only the need for material or research is recorded; no new retrieval or research is performed.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionAre reference dates, corrections and historical verification separated?Required	The original reference date 2026-09-07, empty correction array and empty deliberation string are retained. Cross-checking in the historical verdict-decision record is original history, distinct from current production dates, condition-application times or completed content review. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Original reference date versus creation and application times	Material needed: If new material or corrections arise, preserve original text and separate events, conditions and observations, and verdict decisions for review. Existing records are not retrospectively certified. Only the need for material or research is recorded; no new retrieval or research is performed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionWhat material would directly fill this gap?Supplementary	The null two-night absolute-LPS co-primary finding is retained together with supportive-measure signals. Confirmation of the question requires direct active-versus-sham material on prespecified absolute LPS and longer follow-up. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Question-specific direct comparisons, follow-up and denominator material	Material needed: Prespecified absolute LPS and co-primary plans, actual active and sham exposure, PSG measurements and denominators, models, effects and CIs, and long-term sleep and harm material. Only the need for material or research is recorded; no new retrieval or research is performed.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionIs production separated from content review and implementation advice?Supplementary	This is a record of applied conditions based on a stored summary. Existing content and claim-boundary review is incomplete; candidate review-pending and production-eligibility indicators are retained as history. The original review status is recorded unchanged. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Production request and responsibility for review of existing content	Material needed: Review of existing content and subsequent actual material and correction records. During the original production, clinical original-material comparisons, external reading, new calculations, grade changes, and device, diet or treatment implementation advice were not performed. Only the need for material or research is recorded; no new retrieval or research is performed.

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30 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-07
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: 106 adults with diagnosed insomnia were randomized; detailed analyses and withdrawals by group, night and endpoint are unverified.
Ingredient, formulation and route: A frontal thermal-therapy device regulating forehead temperature at 14–16°C, distinguished from ordinary cold packs
Dose: Original study-device identification: 14–16°C for two nights. This is not an instruction on duration of use, settings, cooling or sleep care.
Comparator: Sham device; actual temperature and operation, blinding and concurrent exposures are not verified in detail.
Measured outcome: Co-primary PSG result for absolute latency to persistent sleep, distinguished from sleep efficiency, relative LPS and supportive latency to stages 1 and 2
Duration: Two-night assessment; baseline and adaptation nights, night-specific analyses, persistence after exposure and long-term follow-up are not verified in detail.
Questions outside this scope: Transferring positive relative or stage-specific supportive findings into co-primary success for absolute LPS; Rejudging a null between-group finding as an exactly zero effect, equivalence or noninferiority; Converting sleep-efficiency percentage points into sleep-latency minutes, subjective outcomes or long-term clinical effects; Adding the same people, nights, endpoints, groups, references or related sheets as new independent trials or participants; New calculations, hypothetical quantities, effects, CIs, grades or independence certification, or instructions for devices, forehead cooling, sleep care or replacement of treatment

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Roth T, Mayleben D, Feldman N, et al. A novel forehead temperature-regulating device for insomnia: a randomized clinical trial. Sleep. 2018;41(5):zsy045. PMID: 29648642. PMCID: PMC5946849. DOI: 10.1093/sleep/zsy045. NCT01966211.

PubMed

Material type: Prospective randomized sham-controlled trial
Materials actually read: Stored summary read; external abstracts, full texts, registrations and plans unread
Findings recorded in the stored summary: -7.9 minutes (95% CI -18.4 to 2.6), P=.092; +0.5 percentage points (-3.4 to 4.5), P=.759
Record level: Parent-endpoint summary in the original evidence list; the scope of the selected direct endpoint and other findings is distinguished through conditions and roles.
Study overlap and independent replication: Parent verdict 2982 and the latency and sleep-efficiency sheets share the same Roth2018 report and 106-person, two-night trial context. The same people, groups, nights, endpoints, supportive analyses, references and related sheets are not added as new independent trials or participants. Linkage by reference is provisional; review of actual cohort and independent-study relationships is incomplete.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	A preserved local copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed.
External abstract	An original identifier, reference or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed.
External full text	An original identifier, reference or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed.
Original registration	An original identifier, reference or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed.
Protocol/SAP	An original identifier, reference or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed.

Report counts versus independent study counts

Parent verdict 2982 and the latency and sleep-efficiency sheets share the same Roth2018 report and 106-person, two-night trial context. The same people, groups, nights, endpoints, supportive analyses, references and related sheets are not added as new independent trials or participants. Linkage by reference is provisional; review of actual cohort and independent-study relationships is incomplete.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which existing absolute-latency claim is being presented?

Required materials and conditions: Separate the selected subclaim wording and original grade from parent context
Conditions for verification: Present original data on separate the selected subclaim wording and original grade from parent context, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect separate the selected subclaim wording and original grade from parent context with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N02 · Which population with insomnia produced these findings?

Required materials and conditions: Diagnosed adults, eligibility and concurrent exposures
Conditions for verification: Present original data on diagnosed adults, eligibility and concurrent exposures, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect diagnosed adults, eligibility and concurrent exposures with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N03 · Is the active device equivalent to an ordinary cold pack?

Required materials and conditions: Study device and actual active intervention
Conditions for verification: Present original data on study device and actual active intervention, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect study device and actual active intervention with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N04 · What were the actual sham-device control conditions?

Required materials and conditions: Sham device, measurement and concurrent treatment
Conditions for verification: Present original data on sham device, measurement and concurrent treatment, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect sham device, measurement and concurrent treatment with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N05 · How many nights were used to assess efficacy?

Required materials and conditions: Measurement nights, duration and repeated measurements
Conditions for verification: Present original data on measurement nights, duration and repeated measurements, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect measurement nights, duration and repeated measurements with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N06 · What exactly defines latency to persistent sleep?

Required materials and conditions: PSG absolute latency to persistent sleep
Conditions for verification: Present original data on PSG absolute latency to persistent sleep, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect PSG absolute latency to persistent sleep with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N07 · Are absolute results distinguished from relative changes?

Required materials and conditions: Effects of interest for absolute LPS and relative sleep-latency change
Conditions for verification: Present original data on effects of interest for absolute LPS and relative sleep-latency change, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect effects of interest for absolute LPS and relative sleep-latency change with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N08 · What are the selected absolute-LPS between-group effect and uncertainty?

Required materials and conditions: Original LPS between-group difference, CI and P value
Conditions for verification: Present original data on original LPS between-group difference, CI and P value, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect original LPS between-group difference, CI and P value with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N09 · Is the co-primary sleep-efficiency result separated from LPS?

Required materials and conditions: The other co-primary PSG endpoint
Conditions for verification: Present original data on the other co-primary PSG endpoint, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect the other co-primary PSG endpoint with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N10 · How do prespecified co-primary success criteria relate to supportive findings?

Required materials and conditions: Failure of both co-primary endpoints and prespecified plans
Conditions for verification: Present original data on failure of both co-primary endpoints and prespecified plans, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect failure of both co-primary endpoints and prespecified plans with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N11 · Were actual group-specific absolute latency values provided?

Required materials and conditions: Baseline and final absolute values by group versus between-group differences
Conditions for verification: Present original data on baseline and final absolute values by group versus between-group differences, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect baseline and final absolute values by group versus between-group differences with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N12 · What is the positive relative-latency signal?

Required materials and conditions: Relative-latency supportive analysis versus the absolute primary result
Conditions for verification: Present original data on relative-latency supportive analysis versus the absolute primary result, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect relative-latency supportive analysis versus the absolute primary result with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N13 · Is latency to sleep stages 1 and 2 the same as latency to persistent sleep?

Required materials and conditions: Distinguish supportive measures for each sleep stage
Conditions for verification: Present original data on distinguish supportive measures for each sleep stage, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect distinguish supportive measures for each sleep stage with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N14 · Is material available to assess selection and multiplicity of supportive findings?

Required materials and conditions: Retain positive supportive measures together with failed primary findings
Conditions for verification: Present original data on retain positive supportive measures together with failed primary findings, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect retain positive supportive measures together with failed primary findings with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N15 · Do 106 participants form the analysis denominator for every endpoint?

Required materials and conditions: Allocation, analysis, completion, withdrawal and night-specific missingness
Conditions for verification: Present original data on allocation, analysis, completion, withdrawal and night-specific missingness, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect allocation, analysis, completion, withdrawal and night-specific missingness with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N16 · Are within-group improvements separated from the between-group effect of interest?

Required materials and conditions: Active-versus-sham comparison and change from baseline
Conditions for verification: Present original data on active-versus-sham comparison and change from baseline, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect active-versus-sham comparison and change from baseline with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N17 · What is the scope of two-night harms and tolerability statements?

Required materials and conditions: Short-term AE patterns versus long-term safety
Conditions for verification: Present original data on short-term AE patterns versus long-term safety, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect short-term AE patterns versus long-term safety with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N18 · Do findings extend to long-term sleep efficacy and safety?

Required materials and conditions: Two-night effects versus persistence and long-term outcomes
Conditions for verification: Present original data on two-night effects versus persistence and long-term outcomes, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect two-night effects versus persistence and long-term outcomes with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N19 · What materials were actually read in this work?

Required materials and conditions: Stored summary and access status of external material
Conditions for verification: Present original data on stored summary and access status of external material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect stored summary and access status of external material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N20 · What does the registration number establish?

Required materials and conditions: Registration identifier in references and evidence versus actual registration reading
Conditions for verification: Present original data on registration identifier in references and evidence versus actual registration reading, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect registration identifier in references and evidence versus actual registration reading with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N21 · Were the protocol and SAP acquired?

Required materials and conditions: Separate entries for prespecified plans, amendments and analysis material
Conditions for verification: Present original data on separate entries for prespecified plans, amendments and analysis material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect separate entries for prespecified plans, amendments and analysis material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N22 · Are funding, support, authors and research involvement separated?

Required materials and conditions: Four categories of company involvement versus public and academic support
Conditions for verification: Present original data on four categories of company involvement versus public and academic support, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect four categories of company involvement versus public and academic support with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N23 · Are unmeasured outcomes, unverified details and null results distinguished?

Required materials and conditions: Reasons for question-specific result and access statuses
Conditions for verification: Present original data on reasons for question-specific result and access statuses, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect reasons for question-specific result and access statuses with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N24 · Are reports, trials, people, measurements and related sheets separated?

Required materials and conditions: Reference linkage and meaning without double counting
Conditions for verification: Present original data on reference linkage and meaning without double counting, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect reference linkage and meaning without double counting with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N25 · Is there evidence of separate independent replication?

Required materials and conditions: Report identity versus independent confirmation
Conditions for verification: Present original data on report identity versus independent confirmation, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect report identity versus independent confirmation with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N26 · Are subclaim grades separated from parent scores and axes?

Required materials and conditions: Selected-record absences versus the parent verdict
Conditions for verification: Present original data on selected-record absences versus the parent verdict, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect selected-record absences versus the parent verdict with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N27 · Are Korean, English and classification scopes preserved as the same original record?

Required materials and conditions: Original Korean and English texts and structured fields
Conditions for verification: Present original data on original Korean and English texts and structured fields, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect original Korean and English texts and structured fields with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N28 · Are reference dates, corrections and historical verification separated?

Required materials and conditions: Original reference date versus creation and application times
Conditions for verification: Present original data on original reference date versus creation and application times, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect original reference date versus creation and application times with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N29 · What material would directly fill this gap?

Required materials and conditions: Question-specific direct comparisons, follow-up and denominator material
Conditions for verification: Present original data on question-specific direct comparisons, follow-up and denominator material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect question-specific direct comparisons, follow-up and denominator material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N30 · Is production separated from content review and implementation advice?

Required materials and conditions: Production request and responsibility for review of existing content
Conditions for verification: Present original data on production request and responsibility for review of existing content, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Why this condition is needed: This is needed to connect production request and responsibility for review of existing content with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

What the statuses mean

Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete: Review of existing content incomplete
Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible: Not applied during this preparation because actual access was not tested
Not applicable: Use with a reason for non-applicability based on an explicit question boundary
Conflicting data: Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-15 · Public page/material version 1.0

The public page and data were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-07) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

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N01 · Which existing absolute-latency claim is being presented?

Current findings: The selected claim is improved absolute latency to persistent sleep, with subclaim grade D and a note that P=.092 was null. Subclaim score, status and axes are absent and are retained separately from parent D with 28 points and its axes.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: The selected endpoint's exact definition and effect of interest, and review of the claim boundary. Parent scores are not used to fill subclaim scores.
Required materials and conditions: Separate the selected subclaim wording and original grade from parent context
Materials to obtain first: The selected endpoint's exact definition and effect of interest, and review of the claim boundary. Parent scores are not used to fill subclaim scores.
Further research: Material needed: The selected endpoint's exact definition and effect of interest, and review of the claim boundary. Parent scores are not used to fill subclaim scores. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on separate the selected subclaim wording and original grade from parent context, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect separate the selected subclaim wording and original grade from parent context with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N02 · Which population with insomnia produced these findings?

Current findings: The original material records randomization of 106 adults with diagnosed insomnia to active or sham devices. Age range, diagnostic details, comorbidities, sleep medication and other exposure details are not established in the stored summary.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original eligibility and exclusion criteria, diagnostic criteria, baseline characteristics, medication and concurrent treatment, and adherence. Application is not extended to every sleep problem.
Required materials and conditions: Diagnosed adults, eligibility and concurrent exposures
Materials to obtain first: Original eligibility and exclusion criteria, diagnostic criteria, baseline characteristics, medication and concurrent treatment, and adherence. Application is not extended to every sleep problem.
Further research: Material needed: Original eligibility and exclusion criteria, diagnostic criteria, baseline characteristics, medication and concurrent treatment, and adherence. Application is not extended to every sleep problem. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on diagnosed adults, eligibility and concurrent exposures, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect diagnosed adults, eligibility and concurrent exposures with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N03 · Is the active device equivalent to an ordinary cold pack?

Current findings: The original intervention was a frontal thermal-therapy device regulating forehead temperature at 14–16°C. The original statement that it is not equivalent to an ordinary cold pack is retained. Temperature identifies the study device and is not an implementation instruction.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Actual device model and settings, exposure, duration of use, adherence and product-support material. No new equivalence with other cooling or sleep devices or instructions for use are produced.
Required materials and conditions: Study device and actual active intervention
Materials to obtain first: Actual device model and settings, exposure, duration of use, adherence and product-support material. No new equivalence with other cooling or sleep devices or instructions for use are produced.
Further research: Material needed: Actual device model and settings, exposure, duration of use, adherence and product-support material. No new equivalence with other cooling or sleep devices or instructions for use are produced. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on study device and actual active intervention, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect study device and actual active intervention with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N04 · What were the actual sham-device control conditions?

Current findings: The original design was prospective, randomized and sham-controlled, and the classification information indicates sham intervention. Actual sham temperature, operation, sensation, successful blinding and concurrent-treatment details are not established in the summary.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original active and sham implementation, allocation concealment, blinding, sensation and expectations, and concurrent exposures in both groups. Sham is not substituted with no intervention or an ordinary cold pack.
Required materials and conditions: Sham device, measurement and concurrent treatment
Materials to obtain first: Original active and sham implementation, allocation concealment, blinding, sensation and expectations, and concurrent exposures in both groups. Sham is not substituted with no intervention or an ordinary cold pack.
Further research: Material needed: Original active and sham implementation, allocation concealment, blinding, sensation and expectations, and concurrent exposures in both groups. Sham is not substituted with no intervention or an ordinary cold pack. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on sham device, measurement and concurrent treatment, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect sham device, measurement and concurrent treatment with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N05 · How many nights were used to assess efficacy?

Current findings: The original material records two-night assessment. Baseline measurement nights, adaptation nights, night-specific findings, averaging and follow-up after exposure are not verified in detail. Two nights are not added as separate trials or participant counts.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Actual PSG measurement schedules, baseline and treatment nights, repeated-measures models and long-term follow-up. No new total night count or observation time is calculated.
Required materials and conditions: Measurement nights, duration and repeated measurements
Materials to obtain first: Actual PSG measurement schedules, baseline and treatment nights, repeated-measures models and long-term follow-up. No new total night count or observation time is calculated.
Further research: Material needed: Actual PSG measurement schedules, baseline and treatment nights, repeated-measures models and long-term follow-up. No new total night count or observation time is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on measurement nights, duration and repeated measurements, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect measurement nights, duration and repeated measurements with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N06 · What exactly defines latency to persistent sleep?

Current findings: The original co-primary endpoints were absolute latency to persistent sleep and absolute sleep efficiency. PSG rules for persistent sleep, timing definitions, scoring, night-specific aggregation and analysis timing are not established from the stored summary alone.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original PSG LPS definitions, scoring blinding, stage and continuity rules, measurement times and analysis units. Subjective sleep onset or entry into a sleep stage is not substituted for LPS.
Required materials and conditions: PSG absolute latency to persistent sleep
Materials to obtain first: Original PSG LPS definitions, scoring blinding, stage and continuity rules, measurement times and analysis units. Subjective sleep onset or entry into a sleep stage is not substituted for LPS.
Further research: Material needed: Original PSG LPS definitions, scoring blinding, stage and continuity rules, measurement times and analysis units. Subjective sleep onset or entry into a sleep stage is not substituted for LPS. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on PSG absolute latency to persistent sleep, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect PSG absolute latency to persistent sleep with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N07 · Are absolute results distinguished from relative changes?

Current findings: The original material distinguishes null co-primary absolute LPS from favorable relative latency to persistent sleep in supportive analyses. Absolute values and relative changes are not combined as the same estimand or success criterion.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original formulas, denominators, analysis models, prespecified hierarchy and endpoint-specific effects and CIs for absolute values, change from baseline and relative change. No new conversion is calculated.
Required materials and conditions: Effects of interest for absolute LPS and relative sleep-latency change
Materials to obtain first: Original formulas, denominators, analysis models, prespecified hierarchy and endpoint-specific effects and CIs for absolute values, change from baseline and relative change. No new conversion is calculated.
Further research: Material needed: Original formulas, denominators, analysis models, prespecified hierarchy and endpoint-specific effects and CIs for absolute values, change from baseline and relative change. No new conversion is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on effects of interest for absolute LPS and relative sleep-latency change, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect effects of interest for absolute LPS and relative sleep-latency change with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N08 · What are the selected absolute-LPS between-group effect and uncertainty?

Current findings: The between-group difference in absolute latency to persistent sleep was -7.9 minutes (95% CI -18.4 to 2.6), P=.092, and the original verdict was null. This is not rejudged as positive, an exactly zero effect, equivalence or noninferiority.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original effect of interest, analysis population, models, CI and P calculations, and separate confirmatory material. No new effect, CI, P value or quantitative example is calculated.
Required materials and conditions: Original LPS between-group difference, CI and P value
Materials to obtain first: Original effect of interest, analysis population, models, CI and P calculations, and separate confirmatory material. No new effect, CI, P value or quantitative example is calculated.
Further research: Material needed: Original effect of interest, analysis population, models, CI and P calculations, and separate confirmatory material. No new effect, CI, P value or quantitative example is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on original LPS between-group difference, CI and P value, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect original LPS between-group difference, CI and P value with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N09 · Is the co-primary sleep-efficiency result separated from LPS?

Current findings: The absolute sleep-efficiency difference was +0.5 percentage points (95% CI -3.4 to 4.5), P=.759. This is another endpoint in the same 106-person, two-night trial, not the absolute-LPS effect or separate independent replication.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Sleep-efficiency calculations, denominators, models, co-primary specifications and endpoint-specific analysis material. Percentage points are not converted into minutes or event effects.
Required materials and conditions: The other co-primary PSG endpoint
Materials to obtain first: Sleep-efficiency calculations, denominators, models, co-primary specifications and endpoint-specific analysis material. Percentage points are not converted into minutes or event effects.
Further research: Material needed: Sleep-efficiency calculations, denominators, models, co-primary specifications and endpoint-specific analysis material. Percentage points are not converted into minutes or event effects. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on the other co-primary PSG endpoint, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect the other co-primary PSG endpoint with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N10 · How do prespecified co-primary success criteria relate to supportive findings?

Current findings: The original material states that both prespecified co-primary PSG endpoints were null and favorable supportive findings do not replace these failures. Prespecification is retained as an original statement, not certification of new reading of the registration or SAP.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Registration, protocol and SAP versions and dates, co-primary success rules, multiplicity plans and amendment history. No new trial-success or grade judgment.
Required materials and conditions: Failure of both co-primary endpoints and prespecified plans
Materials to obtain first: Registration, protocol and SAP versions and dates, co-primary success rules, multiplicity plans and amendment history. No new trial-success or grade judgment.
Further research: Material needed: Registration, protocol and SAP versions and dates, co-primary success rules, multiplicity plans and amendment history. No new trial-success or grade judgment. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on failure of both co-primary endpoints and prespecified plans, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect failure of both co-primary endpoints and prespecified plans with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N11 · Were actual group-specific absolute latency values provided?

Current findings: The stored summary provides the absolute-LPS between-group difference of -7.9 minutes, but not detailed baseline and final group means or variance, night-specific values or changes. Group values are not reverse-calculated from the between-group difference.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Baseline and final LPS values by group and measurement night, variance, analysis populations, models and missingness. No new group values, rates or changes are calculated.
Required materials and conditions: Baseline and final absolute values by group versus between-group differences
Materials to obtain first: Baseline and final LPS values by group and measurement night, variance, analysis populations, models and missingness. No new group values, rates or changes are calculated.
Further research: Material needed: Baseline and final LPS values by group and measurement night, variance, analysis populations, models and missingness. No new group values, rates or changes are calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on baseline and final absolute values by group versus between-group differences, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect baseline and final absolute values by group versus between-group differences with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N12 · What is the positive relative-latency signal?

Current findings: The original counterview records a favorable direction for relative latency to persistent sleep. Individual quantitative effects, CIs, P values and models are absent from the summary; absolute-LPS P=.092 is not copied as the value of this supportive finding.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original tables, definitions, denominators, effects and CIs, prespecified hierarchy and multiplicity plans for that relative measure. The signal is not promoted into established long-term efficacy.
Required materials and conditions: Relative-latency supportive analysis versus the absolute primary result
Materials to obtain first: Original tables, definitions, denominators, effects and CIs, prespecified hierarchy and multiplicity plans for that relative measure. The signal is not promoted into established long-term efficacy.
Further research: Material needed: Original tables, definitions, denominators, effects and CIs, prespecified hierarchy and multiplicity plans for that relative measure. The signal is not promoted into established long-term efficacy. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on relative-latency supportive analysis versus the absolute primary result, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect relative-latency supportive analysis versus the absolute primary result with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N13 · Is latency to sleep stages 1 and 2 the same as latency to persistent sleep?

Current findings: The original statement describes favorable latencies to stages 1 and 2 in supportive analyses. These are not the same findings as absolute latency to persistent sleep or sleep efficiency. Individual stage effects, CIs and P values are not newly filled in.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Stage-specific PSG definitions, original findings, denominators, measurement nights, primary and supportive hierarchy and multiplicity plans. Stage-specific findings are not added as new participants or trials.
Required materials and conditions: Distinguish supportive measures for each sleep stage
Materials to obtain first: Stage-specific PSG definitions, original findings, denominators, measurement nights, primary and supportive hierarchy and multiplicity plans. Stage-specific findings are not added as new participants or trials.
Further research: Material needed: Stage-specific PSG definitions, original findings, denominators, measurement nights, primary and supportive hierarchy and multiplicity plans. Stage-specific findings are not added as new participants or trials. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on distinguish supportive measures for each sleep stage, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect distinguish supportive measures for each sleep stage with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N14 · Is material available to assess selection and multiplicity of supportive findings?

Current findings: The original material explains that foregrounding favorable supportive measures can obscure the core failures. The number of all supportive endpoints, testing plans and selective reporting are not newly established from this summary.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Complete endpoint lists, registration and SAP, amendment history, all findings, multiple-testing plans and comparisons with the paper. No new formal RoB assessment or rejudging.
Required materials and conditions: Retain positive supportive measures together with failed primary findings
Materials to obtain first: Complete endpoint lists, registration and SAP, amendment history, all findings, multiple-testing plans and comparisons with the paper. No new formal RoB assessment or rejudging.
Further research: Material needed: Complete endpoint lists, registration and SAP, amendment history, all findings, multiple-testing plans and comparisons with the paper. No new formal RoB assessment or rejudging. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on retain positive supportive measures together with failed primary findings, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect retain positive supportive measures together with failed primary findings with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N15 · Do 106 participants form the analysis denominator for every endpoint?

Current findings: The original material records randomization of 106 adults and assessment over two nights. Group-specific allocation, analysis and completion, valid PSG data by endpoint, withdrawals and missingness are not established in the stored summary.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Group-specific flow diagrams, analysis populations, missing data by night and endpoint, withdrawal reasons and handling. No new 53/53 allocation, completion count, missing-data count or rate, or total night count is created.
Required materials and conditions: Allocation, analysis, completion, withdrawal and night-specific missingness
Materials to obtain first: Group-specific flow diagrams, analysis populations, missing data by night and endpoint, withdrawal reasons and handling. No new 53/53 allocation, completion count, missing-data count or rate, or total night count is created.
Further research: Material needed: Group-specific flow diagrams, analysis populations, missing data by night and endpoint, withdrawal reasons and handling. No new 53/53 allocation, completion count, missing-data count or rate, or total night count is created. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on allocation, analysis, completion, withdrawal and night-specific missingness, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect allocation, analysis, completion, withdrawal and night-specific missingness with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N16 · Are within-group improvements separated from the between-group effect of interest?

Current findings: The original reader answer gives between-group differences, while supportive relative-latency change is separate. Detailed natural change in each group, sham responses, models and adjustment are absent; within-group improvement is not transferred into an additional active-treatment effect.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original baseline and final group values, prespecified estimands, repeated-measures and adjustment models, concurrent exposures and sham responses. No new difference or ratio is calculated.
Required materials and conditions: Active-versus-sham comparison and change from baseline
Materials to obtain first: Original baseline and final group values, prespecified estimands, repeated-measures and adjustment models, concurrent exposures and sham responses. No new difference or ratio is calculated.
Further research: Material needed: Original baseline and final group values, prespecified estimands, repeated-measures and adjustment models, concurrent exposures and sham responses. No new difference or ratio is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on active-versus-sham comparison and change from baseline, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect active-versus-sham comparison and change from baseline with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N17 · What is the scope of two-night harms and tolerability statements?

Current findings: The original material records broadly similar adverse-event patterns with the sham device over two nights and reports of headache and other events. Group-specific event counts, severity, attribution, discontinuation and exposure denominators are not verified in detail. Similar patterns are not converted into absence of harms or equivalence.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: AE collection methods, group-specific exposure and harm denominators, headache and other events, discontinuation, attribution and long-term harms. No new harm rates or device-care or implementation instructions.
Required materials and conditions: Short-term AE patterns versus long-term safety
Materials to obtain first: AE collection methods, group-specific exposure and harm denominators, headache and other events, discontinuation, attribution and long-term harms. No new harm rates or device-care or implementation instructions.
Further research: Material needed: AE collection methods, group-specific exposure and harm denominators, headache and other events, discontinuation, attribution and long-term harms. No new harm rates or device-care or implementation instructions. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on short-term AE patterns versus long-term safety, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect short-term AE patterns versus long-term safety with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N18 · Do findings extend to long-term sleep efficacy and safety?

Current findings: The original material explains that separate trials are needed for long-term efficacy and safety. Some supportive sleep-latency signals are not extended into long-term insomnia improvement, daytime function, replacement of treatment or long-term safety.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Longer active-versus-sham confirmatory trials with prespecified absolute LPS, clinical sleep and function, long-term exposure and harms, discontinuation and recurrence. No device, cooling, sleep-care or treatment-replacement implementation instructions are provided.
Required materials and conditions: Two-night effects versus persistence and long-term outcomes
Materials to obtain first: Longer active-versus-sham confirmatory trials with prespecified absolute LPS, clinical sleep and function, long-term exposure and harms, discontinuation and recurrence. No device, cooling, sleep-care or treatment-replacement implementation instructions are provided.
Further research: Material needed: Longer active-versus-sham confirmatory trials with prespecified absolute LPS, clinical sleep and function, long-term exposure and harms, discontinuation and recurrence. No device, cooling, sleep-care or treatment-replacement implementation instructions are provided. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on two-night effects versus persistence and long-term outcomes, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect two-night effects versus persistence and long-term outcomes with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N19 · What materials were actually read in this work?

Current findings: The complete parent summary was read for production and preserved in its original form. Summary reading in material entries refers to the stored summary; external abstract, full text, registration, protocol and SAP were not read. The presence of a URL or PMCID is not promoted into external reading.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing.
Required materials and conditions: Stored summary and access status of external material
Materials to obtain first: Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing.
Further research: Material needed: Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on stored summary and access status of external material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect stored summary and access status of external material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N20 · What does the registration number establish?

Current findings: NCT01966211 appears in the original evidence and citation. The identifier is retained; there has been no new reading or verification of registration content, versions, timing, results disclosure or agreement with plans. An official registration URL is not guessed.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration.
Required materials and conditions: Registration identifier in references and evidence versus actual registration reading
Materials to obtain first: Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration.
Further research: Material needed: Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on registration identifier in references and evidence versus actual registration reading, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect registration identifier in references and evidence versus actual registration reading with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N21 · Were the protocol and SAP acquired?

Current findings: Specific protocol and SAP URLs, original text, versions and dates were not newly acquired or read. Parent statements about prespecified endpoints and historical cross-checking are retained as history and are not described as new content review.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes.
Required materials and conditions: Separate entries for prespecified plans, amendments and analysis material
Materials to obtain first: Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes.
Further research: Material needed: Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on separate entries for prespecified plans, amendments and analysis material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect separate entries for prespecified plans, amendments and analysis material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N22 · Are funding, support, authors and research involvement separated?

Current findings: Original funding records list NIH and NHLBI support, Ebb Therapeutics device and study involvement, and a company founder and executive as author. Public support is distinguished from company device support, study involvement and employee or executive authors. Separate amounts of company funding and detailed analysis and design roles are not established.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Separate original funding sources, food or device support, employee and executive authors, design, analysis and data control, and conflicts of interest. Original independence axes are not used as new independence certification.
Required materials and conditions: Four categories of company involvement versus public and academic support
Materials to obtain first: Separate original funding sources, food or device support, employee and executive authors, design, analysis and data control, and conflicts of interest. Original independence axes are not used as new independence certification.
Further research: Material needed: Separate original funding sources, food or device support, employee and executive authors, design, analysis and data control, and conflicts of interest. Original independence axes are not used as new independence certification. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on four categories of company involvement versus public and academic support, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect four categories of company involvement versus public and academic support with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N23 · Are unmeasured outcomes, unverified details and null results distinguished?

Current findings: The original null absolute-LPS P=.092, favorable supportive signals and unverified external details are different states.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Material to establish direct measurement, original tables, analysis plans and material access. Unread material is not substituted for unreported findings, zero studies or zero effects.
Required materials and conditions: Reasons for question-specific result and access statuses
Materials to obtain first: Material to establish direct measurement, original tables, analysis plans and material access. Unread material is not substituted for unreported findings, zero studies or zero effects.
Further research: Material needed: Material to establish direct measurement, original tables, analysis plans and material access. Unread material is not substituted for unreported findings, zero studies or zero effects. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on reasons for question-specific result and access statuses, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect reasons for question-specific result and access statuses with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N24 · Are reports, trials, people, measurements and related sheets separated?

Current findings: Parent verdict 2982 and the latency and sleep-efficiency sheets share the same Roth2018 report and 106-person, two-night trial context. The same people, groups, nights, endpoints, supportive analyses, references and related sheets are not added as new independent trials or participants. One current report link is not a certified count of unique trials or participants.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded.
Required materials and conditions: Reference linkage and meaning without double counting
Materials to obtain first: Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded.
Further research: Material needed: Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on reference linkage and meaning without double counting, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect reference linkage and meaning without double counting with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N25 · Is there evidence of separate independent replication?

Current findings: Original parent replication and independence axes R1/I0 are retained. Reuse of the current reference and related sheets is not certified as new independent efficacy or harm replication.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Reports with separate prespecified plans, populations, interventions and controls, direct endpoints, follow-up, effects and CIs, and funding and author relationships appropriate to the question. No new search or independence adjudication.
Required materials and conditions: Report identity versus independent confirmation
Materials to obtain first: Reports with separate prespecified plans, populations, interventions and controls, direct endpoints, follow-up, effects and CIs, and funding and author relationships appropriate to the question. No new search or independence adjudication.
Further research: Material needed: Reports with separate prespecified plans, populations, interventions and controls, direct endpoints, follow-up, effects and CIs, and funding and author relationships appropriate to the question. No new search or independence adjudication. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on report identity versus independent confirmation, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect report identity versus independent confirmation with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N26 · Are subclaim grades separated from parent scores and axes?

Current findings: The selected subclaim grade and note are retained in their original form, and absent score, status and axes remain unrecorded. Parent D with 28 points, safety and axes are parent context. No new score, grade or official RoB2 or GRADE certification is produced.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values.
Required materials and conditions: Selected-record absences versus the parent verdict
Materials to obtain first: Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values.
Further research: Material needed: Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on selected-record absences versus the parent verdict, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect selected-record absences versus the parent verdict with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N27 · Are Korean, English and classification scopes preserved as the same original record?

Current findings: The complete parent Korean and English texts, classification information, evidence and citations, and selected subclaim wording, grade and note are preserved in the complete stored summary. This is not a new comparison with the English original paper or another verdict.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Material for review of differences in original languages, selected and parent claims, terminology, visits and measurement definitions. General wording is not extended into new clinical proof.
Required materials and conditions: Original Korean and English texts and structured fields
Materials to obtain first: Material for review of differences in original languages, selected and parent claims, terminology, visits and measurement definitions. General wording is not extended into new clinical proof.
Further research: Material needed: Material for review of differences in original languages, selected and parent claims, terminology, visits and measurement definitions. General wording is not extended into new clinical proof. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on original Korean and English texts and structured fields, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect original Korean and English texts and structured fields with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N28 · Are reference dates, corrections and historical verification separated?

Current findings: The original reference date 2026-09-07, empty correction array and empty deliberation string are retained. Cross-checking in the historical verdict-decision record is original history, distinct from current production dates, condition-application times or completed content review.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: If new material or corrections arise, preserve original text and separate events, conditions and observations, and verdict decisions for review. Existing records are not retrospectively certified.
Required materials and conditions: Original reference date versus creation and application times
Materials to obtain first: If new material or corrections arise, preserve original text and separate events, conditions and observations, and verdict decisions for review. Existing records are not retrospectively certified.
Further research: Material needed: If new material or corrections arise, preserve original text and separate events, conditions and observations, and verdict decisions for review. Existing records are not retrospectively certified. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on original reference date versus creation and application times, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect original reference date versus creation and application times with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N29 · What material would directly fill this gap?

Current findings: The null two-night absolute-LPS co-primary finding is retained together with supportive-measure signals. Confirmation of the question requires direct active-versus-sham material on prespecified absolute LPS and longer follow-up.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Prespecified absolute LPS and co-primary plans, actual active and sham exposure, PSG measurements and denominators, models, effects and CIs, and long-term sleep and harm material.
Required materials and conditions: Question-specific direct comparisons, follow-up and denominator material
Materials to obtain first: Prespecified absolute LPS and co-primary plans, actual active and sham exposure, PSG measurements and denominators, models, effects and CIs, and long-term sleep and harm material.
Further research: Material needed: Prespecified absolute LPS and co-primary plans, actual active and sham exposure, PSG measurements and denominators, models, effects and CIs, and long-term sleep and harm material. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on question-specific direct comparisons, follow-up and denominator material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect question-specific direct comparisons, follow-up and denominator material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N30 · Is production separated from content review and implementation advice?

Current findings: This is a record of applied conditions based on a stored summary. Existing content and claim-boundary review is incomplete; candidate review-pending and production-eligibility indicators are retained as history. The original review status is recorded unchanged.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Review of existing content and subsequent actual material and correction records. During the original production, clinical original-material comparisons, external reading, new calculations, grade changes, and device, diet or treatment implementation advice were not performed.
Required materials and conditions: Production request and responsibility for review of existing content
Materials to obtain first: Review of existing content and subsequent actual material and correction records. During the original production, clinical original-material comparisons, external reading, new calculations, grade changes, and device, diet or treatment implementation advice were not performed.
Further research: Material needed: Review of existing content and subsequent actual material and correction records. During the original production, clinical original-material comparisons, external reading, new calculations, grade changes, and device, diet or treatment implementation advice were not performed. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on production request and responsibility for review of existing content, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect production request and responsibility for review of existing content with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01