Forehead-cooling device × Absolute sleep efficiency: The original null result and remaining evidence gaps

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 · Absolute sleep efficiency and evidence gapsHow is the selected sleep-efficiency claim distinguished from the related latency claim?Required	The selected existing question is improved absolute sleep efficiency. Its subclaim record is linked while improved absolute latency to persistent sleep and parent context are retained. These are not counted as new questions, subdivisions or trials. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Clinical independence has not been newly certified.	Sleep-efficiency question and verdict record versus parent and latency context	A prespecified plan distinguishing sleep-efficiency and latency effects of interest
2	Partly verified	Full text not readStored summary read	N02 · Absolute sleep efficiency and evidence gapsWhat are the subclaim grade, note and absent values?Required	The selected grade D and original note that P=.759 was null are retained. Subclaim score, status and axes fields are absent; parent D with 28 points and axes are separate historical values. R01	Some original summary information was linked for production; clinical verification/review is incomplete. The original subclaim lacks a score, status and axes.	Subclaim D and note, absent score, status and axes, and parent history	Records separating existing grades and values from updates with additional evidence
3	Partly verified	Full text not readStored summary read	N03 · Absolute sleep efficiency and evidence gapsWhich people with insomnia were studied?Required	The original research description records randomization of 106 adults with diagnosed insomnia to active or sham devices. This is not direct material for every sleep problem or other disease population. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Exact diagnostic criteria, duration, severity, inclusion and exclusion criteria, and demographic characteristics are unverified.	Diagnosed adults with insomnia and recruitment and baseline scope	Research specifying the population with insomnia
4	Unverified	Full text not readStored summary read	N04 · Absolute sleep efficiency and evidence gapsWere comorbidities, medications and baseline sleep established?Required	The original summary does not separately present baseline sleep efficiency or latency, medications, comorbidities, or selection and control of other treatments. R01	Required direct material has not been verified within the current summary and unread-external-material scope. Baseline sleep, medical history and medications, concurrent treatment and between-group differences are unverified.	Baseline insomnia, medication and concurrent treatment, and assessment criteria	Research specifying shared conditions and concurrent treatment
5	Partly verified	Full text not readStored summary read	N05 · Absolute sleep efficiency and evidence gapsWhat distinguishes the active device from an ordinary cold pack?Required	The original device delivered frontal thermal therapy regulating forehead temperature at 14-16°C. The existing study-conditions description records that it is not the same intervention as an ordinary cold pack. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Device model and components, wearing and operating duration, temperature measurement and actual adherence are unverified.	Device type, active temperature and study exposure	Research specifying the device and active exposure
6	Partly verified	Full text not readStored summary read	N06 · Absolute sleep efficiency and evidence gapsWhat were the sham-device control conditions?Required	The original records a randomized comparison of active cooling and a sham device. Sham temperature, sensation, appearance, operation and blinding details are not presented. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Sham specifications, actual adherence, recognition of conditions and shared procedures are unverified.	Sham design, exposure and comparison, and feasibility of blinding	Research specifying the sham intervention and comparison of interest
7	Partly verified	Full text not readStored summary read	N07 · Absolute sleep efficiency and evidence gapsHow are two-night exposure and measurement separated from lasting effects?Required	The original records 106 participants and two nights of assessment and efficacy follow-up. Night-specific values, order, baseline or adaptation nights, and long-term or post-treatment follow-up details are absent from the summary. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Each night's and baseline assessment schedules, analytical aggregation and long-term outcomes are unverified.	Actual measurement nights, exposure duration, and baseline and follow-up schedules	Research distinguishing baseline, measurement nights and follow-up in advance
8	Partly verified	Full text not readStored summary read	N08 · Absolute sleep efficiency and evidence gapsHow is absolute sleep efficiency defined and measured by PSG?Required	The original selected outcome is absolute sleep efficiency, described as one co-primary PSG endpoint. Its between-group result uses percentage points. Detailed formulas, PSG scoring and criteria are not presented. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Sleep-efficiency formulas and denominators, measurement, scoring and eligibility criteria are unverified.	Sleep-efficiency definition, measurement and calculation units, and assessment procedures	Research with explicit sleep-efficiency and measurement plans
9	Partly verified	Full text not readStored summary read	N09 · Absolute sleep efficiency and evidence gapsWhat are the original sleep-efficiency between-group difference, CI and P value?Required	The original reader answer records an absolute sleep-efficiency between-group difference of +0.5 percentage points (95% CI -3.4 to 4.5), P=.759. The null statement in the selected subclaim note is retained; no new effect or CI is calculated. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Detailed models, adjustment, denominators and aggregation of measurement nights for the contrast direction are unverified.	Original comparison of +0.5 percentage points, 95% CI -3.4 to 4.5, P=.759	Research prespecifying effects of interest, intervals and measurement nights
10	Unverified	Full text not readStored summary read	N10 · Absolute sleep efficiency and evidence gapsWere group-specific absolute, baseline and final values and changes established?Required	The current summary provides the absolute sleep-efficiency between-group difference, but does not separately provide each group's absolute values, baseline values, changes from baseline or night-specific values. R01	Required direct material has not been verified within the current summary and unread-external-material scope. Group- and night-specific absolute values, baseline values and changes, variance, CIs and adjustment are unverified.	Group-specific sleep efficiency, baseline, final values and changes, and adjustment	Plans distinguishing absolute values and changes, and within-group and between-group comparisons
11	Partly verified	Full text not readStored summary read	N11 · Absolute sleep efficiency and evidence gapsHow are the original CI and null statement separated from importance?Required	Original CIs and P values are retained. Parent precision C0 and effect E0 are historical axes. Clinical importance, equivalence margins and individual responses have not been separately established. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Importance criteria, prespecified power and equivalence margins, and model details are unverified.	Precision, importance, the original null result and clinical interpretation	Research prespecifying intervals, importance and effects of interest
12	Partly verified	Full text not readStored summary read	N12 · Absolute sleep efficiency and evidence gapsWhat is the context of the related absolute-latency claim?Supplementary	The latency sheet has grade D and a null P=.092; the original parent between-group difference is -7.9 minutes (95% CI -18.4 to 2.6), P=.092. This remains a latency result and is not transferred into selected sleep efficiency in percentage points. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Latency definitions, individual and night-specific values, and model details are unverified.	Different units and effects for latency and selected sleep efficiency	Plans distinguishing latency and sleep efficiency
13	Partly verified	Full text not readStored summary read	N13 · Absolute sleep efficiency and evidence gapsWhat are the relative-latency and sleep-stage supportive findings?Supplementary	The original states that relative latency to persistent sleep and some latencies to stages 1 and 2 favored treatment in supportive analyses. Exact values, CIs, denominators and analysis hierarchy are absent from the summary. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Exact definitions, effects, CIs, prespecified or exploratory plans, and denominators for supportive findings are unverified.	Relative persistent-sleep latency and entry to stages 1 and 2 versus the selected finding	Confirmatory research separating primary, secondary and exploratory findings
14	Unverified	Full text not readStored summary read	N14 · Absolute sleep efficiency and evidence gapsWere other sleep outcomes, symptoms and quality of life established?Supplementary	The current summary's main findings concern PSG latency, sleep efficiency and supportive latency measures. Separate direct figures for subjective insomnia symptoms, quality of life, daytime function and other sleep outcomes are absent. R01	Required direct material has not been verified within the current summary and unread-external-material scope. Those outcome definitions, effects, CIs, denominators and duration are unverified.	Objective selected endpoints versus subjective and everyday outcomes	Plans distinguishing PSG, symptoms and function
15	Partly verified	Full text not readStored summary read	N15 · Absolute sleep efficiency and evidence gapsAre original prespecified co-primary statements separated from reading external plans?Required	The original evidence and Korean and English texts record two PSG endpoints as prespecified co-primary outcomes and describe both as null. This original hierarchy is retained, without new reading or certification of external plans. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Actual hierarchy, dates and success rules in registration versions, protocols and SAPs have not been read.	Original co-primary hierarchy for absolute persistent-sleep latency and absolute sleep efficiency	Research specifying co-primary outcomes and success criteria
16	Partly verified	Full text not readStored summary read	N16 · Absolute sleep efficiency and evidence gapsWhat separates the registration identifier from actual registration and plan content?Required	NCT01966211 in the evidence and citation is linked in its original form. External registration, protocol and SAP have not been newly retrieved or read. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Actual registration content, amendments, versions, dates and plans are unverified.	Original NCT01966211 identifier versus versions, dates and reading	Records linking plan amendments and published findings
17	Partly verified	Full text not readStored summary read	N17 · Absolute sleep efficiency and evidence gapsWere supportive and exploratory findings, multiplicity and selective reporting addressed?Required	The parent primary-failed and secondary-positive indicator is true, and null co-primary and positive supportive findings are retained as historical context. Whether supportive findings were prespecified secondary or exploratory analyses, and detailed multiplicity handling, remain unverified. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Supportive versus exploratory classification, testing lists, multiplicity and selective-reporting plans are unverified.	Positive supportive findings after primary failure, multiplicity and prespecified analyses	Research fixing the hierarchy of primary, secondary and exploratory outcomes
18	Partly verified	Full text not readStored summary read	N18 · Absolute sleep efficiency and evidence gapsWere randomization, allocation concealment and blinding established?Required	The original design is a prospective randomized sham-controlled trial. Allocation sequence, concealment, participant and assessor blinding, and recognition of conditions are not separately available in the summary. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Sequence generation, concealment, blinding, recognition of conditions and baseline balance are unverified.	Actual procedures for the prospective randomized sham comparison	Blinding and allocation plans for device-versus-sham comparisons
19	Partly verified	Full text not readStored summary read	N19 · Absolute sleep efficiency and evidence gapsWhat are total 106 and group- and outcome-specific allocation and denominators?Required	The original records randomization of 106 adults with insomnia and two nights. Group-specific allocation and completion, and analysis denominators for each PSG endpoint, night and model are not separately presented. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Group-specific flow, completion and analysis, and valid night and endpoint denominators are unverified.	Overall allocation versus completion, analysis, and night- and endpoint-specific denominators	Plans distinguishing allocation, people, nights and analysis populations
20	Unverified	Full text not readStored summary read	N20 · Absolute sleep efficiency and evidence gapsWhat are the analysis units for nights, baseline and repeated measurements, and people?Required	The original states two nights, but night-specific and aggregated effects, baseline adjustment and repeated-measures correlation handling are not detailed. Nights from the same person are not counted as independent people or trials. R01	Required direct material has not been verified within the current summary and unread-external-material scope. Night-specific data, repeated-measures and aggregation methods, and baseline and period models are unverified.	Nights and visits in the same participants, effects of interest and correlation	Research specifying repeated observations and participant-level effects of interest
21	Unverified	Full text not readStored summary read	N21 · Absolute sleep efficiency and evidence gapsHow are withdrawal, incomplete assessments, ineligible PSG and missing data handled?Required	The original 106-person, two-night summary does not separately present group-specific withdrawal, incomplete or ineligible PSG, missing endpoints or handling methods. R01	Required direct material has not been verified within the current summary and unread-external-material scope. Reasons for missingness and discontinuation, denominators, imputation, sensitivity analyses and analysis populations are unverified.	Missing participants and nights, reasons for missingness and discontinuation, and handling	Research prespecifying missingness and effects of interest
22	Partly verified	Full text not readStored summary read	N22 · Absolute sleep efficiency and evidence gapsAre within-group, between-group, adjusted, absolute and change effects distinguished?Required	The original reader answer provides between-group differences for absolute PSG endpoints. Within-group changes, adjustment models, change contrasts and relative supportive analyses are distinguished from these values. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Models, adjustment, baseline values, changes, within-group and between-group contrasts, and supportive definitions are unverified.	Original between-group contrast versus each group's changes, adjustment and models	Research separating absolute values, changes, relative measures, within-group and between-group contrasts
23	Unverified	Full text not readStored summary read	N23 · Absolute sleep efficiency and evidence gapsWhat are actual device exposure, adherence, deviations and concurrent treatment?Required	Only original active exposure at 14-16°C, sham and two-night information are retained. Actual device operation, wearing, discontinuation, cross-use and concurrent sleep-treatment details are not presented. R01	Required direct material has not been verified within the current summary and unread-external-material scope. Adherence, deviations, shared care, and medication and treatment changes are unverified.	Actual device operation, wearing, discontinuation and shared conditions	Research distinguishing actual exposure from assignment effects of interest
24	Partly verified	Full text not readStored summary read	N24 · Absolute sleep efficiency and evidence gapsWhat original information describes developer and public support and author interests?Required	Original funding information records NIH/NHLBI support, Ebb Therapeutics device and study involvement, and company founder and executive authorship. Public support does not erase developer involvement or guarantee independence. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Financial and in-kind support, design, analysis and data-access roles, and detailed disclosures are unverified.	NIH/NHLBI and Ebb Therapeutics support and author roles	Explicit reporting of support and design and analysis roles
25	Partly verified	Full text not readStored summary read	N25 · Absolute sleep efficiency and evidence gapsHow are reports, trials, related claims, nights and groups linked within the same family?Required	The Roth2018 report is linked through one existing evidence entry and one citation entry. Active and sham groups, two nights, co-primary and supportive outcomes, and latency and sleep-efficiency sheets share the same original context and are not added as new independent trials or participants. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Related report/trial relationships and unique trial/participant totals are unverified.	The single Roth2018 reference and trial versus duplicate observations	Records distinguishing reports from study families
26	Unverified	Full text not readStored summary read	N26 · Absolute sleep efficiency and evidence gapsWhat independent confirmation or replication supports selected sleep efficiency?Required	The parent records the context of one small two-night trial and absent long-term confirmation. Other independent research has not been searched or verified here. R01	Required direct material has not been verified within the current summary and unread-external-material scope. Populations, devices, endpoints, duplication and independence of separate direct reports are unverified.	Direct independent research on the same absolute sleep-efficiency question	Separate confirmatory research addressing the same question
27	Partly verified	Full text not readStored summary read	N27 · Absolute sleep efficiency and evidence gapsCan findings apply to other devices, populations, durations or subgroups?Supplementary	The material concerns the original device and adults with insomnia over two nights. Direct effects or durations for other devices, ordinary cold packs, ages, diseases or baseline-sleep groups are not presented. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Direct population, device, subgroup and long-term findings and interactions are unverified.	Extrapolation beyond the original device and population to general cooling and subgroups	Research specifying direct applicability
28	Partly verified	Full text not readStored summary read	N28 · Absolute sleep efficiency and evidence gapsAre PSG findings distinguished from long-term and patient-important insomnia effects?Supplementary	Current PSG sleep-efficiency and latency material and supportive signals have a short-term scope. Long-term insomnia course, daytime function, quality of life and treatment-replacement effects require separate material. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Direct persistence, post-discontinuation, patient-important and treatment-replacement outcomes are unverified.	Two-night objective measures versus symptoms, everyday function and persistence	Research separating PSG from long-term clinical questions
29	Partly verified	Full text not readStored summary read	N29 · Absolute sleep efficiency and evidence gapsWhat has actually been obtained and read, and what do URLs and registration links mean?Required	The complete stored verdict 2982 summary was read for production and saved as a copy. Original PubMed URL, PMCID and NCT identifiers link sources; external content and links have not been newly accessed or verified. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Current verification of detailed external original methods, findings, registration and plans is incomplete.	Local stored summary versus external abstract, full text and plans	Records separating summary preservation from new acquisition and reading
30	Partly verified	Full text not readStored summary read	N30 · Absolute sleep efficiency and evidence gapsHow are Korean and English texts, dates, corrections, empty values and historical axes preserved?Required	Complete Korean and English texts, reference date 2026-09-07, an empty correction array, empty deliberation string and parent D with 28 points are retained. Axes B/S/R1/I0/E0/B2/C0, a true primary-failed and secondary-positive indicator, three other false indicators, and empty grade-override reasons are history. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Detailed external translation and comparisons with original texts, corrections and registration were not performed here.	Original language texts, dates, corrections, axes and verification statements	Separation of original-value preservation from new evidence and changes
31	Partly verified	Full text not readStored summary read	N31 · Absolute sleep efficiency and evidence gapsWere adverse-event collection, definitions and scope established?Supplementary	The safety description records broadly similar adverse-event patterns to sham over two nights, with headache and other events reported. Collection, classification, severity and the full event scope are not detailed. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Collection, definitions, severity, complete harm events and discontinuation tables are unverified.	Active and passive collection, event definitions, severity and discontinuation	Research specifying harm collection separately from efficacy
32	Unverified	Full text not readStored summary read	N32 · Absolute sleep efficiency and evidence gapsWhich group, event and denominator does the headache report refer to?Supplementary	The original states only that headache and other events were reported. Active or sham group, numbers of people and events, severity and attribution are not separately established in the summary. R01	Required direct material has not been verified within the current summary and unread-external-material scope. Group-specific headache counts, valid denominators, severity, causality and timing are unverified.	Headache groups, people, events, attribution and denominators	Harm research with explicit event, person and exposure units
33	Unverified	Full text not readStored summary read	N33 · Absolute sleep efficiency and evidence gapsWhat are short-term harm-comparison denominators, differences and CIs?Supplementary	The original records broadly similar acute tolerability to sham. Group-specific harm-collection and event denominators, effects, CIs and equivalence tests are not presented. R01	Required direct material has not been verified within the current summary and unread-external-material scope. Group- and night-specific harm denominators, events, exposure and comparison CIs are unverified.	Group-specific collection populations, event and exposure denominators, and comparisons	Plans distinguishing efficacy populations from harm-collection populations
34	Partly verified	Full text not readStored summary read	N34 · Absolute sleep efficiency and evidence gapsWhat are harm timing and delayed or long-term findings after two nights?Supplementary	Original two-night tolerability is retained, but exact headache and event timing and delayed or long-term post-treatment observations are absent from the summary. The original states this is not material for determining long-term safety. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Harms by time and duration, and long-term and post-discontinuation material are unverified.	Exposure and event timing and post-discontinuation follow-up	Research prespecifying delayed and long-term harms
35	Unverified	Full text not readStored summary read	N35 · Absolute sleep efficiency and evidence gapsWhat links harms to the device, sham, medical history or medications?Supplementary	The original supplies device, sham and headache context. Specific device and exposure details, alternative causes involving medical history and medications, and event attribution are absent from the summary. R01	Required direct material has not been verified within the current summary and unread-external-material scope. Actual event-specific exposure, medical history, concurrent treatment, attribution and alternative causes are unverified.	Temperature, pressure and other exposure, alternative causes and concurrent conditions	Harm plans distinguishing exposure of interest from alternative causes
36	Unverified	Full text not readStored summary read	N36 · Absolute sleep efficiency and evidence gapsWere harm-related discontinuation and missing PSG established?Supplementary	The original 106-person, two-night and tolerability descriptions do not separately describe harm-related discontinuation or collection and handling for people with missing data. R01	Required direct material has not been verified within the current summary and unread-external-material scope. Group-specific discontinuation and missingness reasons, their relation to harms and missing-data handling are unverified.	Discontinuation and missingness reasons, completion of harm collection and denominators	Plans distinguishing missingness from harm-related discontinuation
37	Unverified	Full text not readStored summary read	N37 · Absolute sleep efficiency and evidence gapsWas independent harm evidence or separate event material obtained?Supplementary	The current preserved list concerns this two-night efficacy-trial report. Separate harm reports have not been searched or obtained here; safety statements from related claims or nights are not counted as independent reports. R01	Required direct material has not been verified within the current summary and unread-external-material scope. Identity, populations, devices, durations and duplication of independent harm reports are unverified.	Independent harm reports for the same device, population and duration	Independent safety research specifying population, device and exposure
38	Unverified	Full text not readStored summary read	N38 · Absolute sleep efficiency and evidence gapsWhat is known about safety in vulnerable populations, other diseases and repeated exposure?Supplementary	Two-night material in adults with insomnia is not used to judge other diseases, populations, repeated use or long-term harms. Original safety caution and long-term limitations are retained. R01	Required direct material has not been verified within the current summary and unread-external-material scope. Direct harm outcomes for vulnerable populations, diseases and repeated or long-term exposure are unverified.	Population- and disease-specific and long-term device-safety scope	Research specifying population and repeated or long-term safety questions
39	Partly verified	Full text not readStored summary read	N39 · Absolute sleep efficiency and evidence gapsHow are null PSG efficacy and safety or causal judgments separated?Supplementary	Null absolute sleep efficiency, broadly similar short-term tolerability to sham, headache reports and parent safety caution are recorded separately. Failed efficacy does not establish harm or certify harmlessness. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Comparative and causal safety and direct long-term material are unverified.	Separation of sleep efficiency, harm comparisons, original caution and causality	Plans separating different effects of interest and outcomes
40	Partly verified	Full text not readStored summary read	N40 · Absolute sleep efficiency and evidence gapsHow are subsequent material, condition versions, historical candidates and incomplete review linked?Supplementary	Conditions were preserved and frozen before separate application. Existing candidate review-pending and production-eligibility indicators are retained as history. Current content and claim-boundary review is incomplete, with false completion indicators, zero new units and an unrecorded final independent count. R01	Some information from the original summary is linked for production; clinical verification and content review are not complete. Subsequent original material, actual reading and change events, and final user decisions on review and independence are not yet available.	Identity, units and denominators, outcome hierarchy, reading and change events, and original candidates	Research directly addressing the selected absolute sleep-efficiency gap

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40 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 insomnia, two nights
Ingredient, formulation and route: A forehead temperature-regulating device delivering frontal thermal therapy at 14-16°C
Dose: Original active frontal thermal exposure at 14-16°C; not device-setting, cooling or sleep-care instructions
Comparator: Original sham device; detailed operation, temperature, blinding and shared conditions unverified
Measured outcome: Original between-group difference in the absolute sleep-efficiency co-primary PSG endpoint, in percentage points; separate from related latency and supportive findings
Duration: Two nights
Questions outside this scope: Replacing a null absolute sleep-efficiency co-primary result with positive supportive latency findings; Converting a between-group percentage-point difference into group or individual changes, relative percentages or time; Adding related sheets, groups, nights, visits or the same report as independent trials or participants; Extending two-night tolerability or PSG findings into long-term efficacy, safety or overall treatment success; Device, forehead-cooling, sleep, insomnia or treatment-replacement implementation instructions

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: Stored report of Roth2018 two-night active-versus-sham device PSG findings
Materials actually read: Summary read; external materials unread, access not attempted
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: Selected absolute sleep efficiency +0.5 percentage points (CI -3.4 to 4.5), P=.759 is the original between-group finding. Latency -7.9 minutes (CI -18.4 to 2.6), P=.092 is related-claim context. Group-specific absolute values and changes, night-specific denominators and adjustment details are unverified. Positive supportive latency findings concern other outcomes.
Study overlap and independent replication: Link Roth2018 active and sham groups, people, two nights, absolute, supportive and co-primary findings, and parent, latency and sleep-efficiency sheets within the same trial and reference. These are not added as new independent trials or participants.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved summary	Summary read	Summary read	Only acquisition and reading of the complete parent summary are meant; original paper and registration have not been obtained.
Abstract	External materials unread/needed	Unread; access not attempted	Not read	Only the original citation link is connected. External access, content verification and link tests have not been attempted.
Full paper	External materials unread/needed	Unread; access not attempted	Not read	The original PMCID reference is retained; full-text content has not been newly obtained or read.
Registration material	External materials unread/needed	Unread; access not attempted	Not read	Original NCT01966211 identifier retained. Registration versions and content unread; access not attempted.
Protocol	External materials unread/needed	Unread; access not attempted	Not read	Original active and sham, PSG and night, co-primary and supportive, and harm plans are needed. Public availability and existence are unverified.
Statistical analysis plan	External materials unread/needed	Unread; access not attempted	Not read	Original plans for absolute values, changes, between-group and within-group contrasts, repeated nights, missingness, hierarchy and multiplicity are needed.
Result tables and PSG, denominator and harm records	External materials unread/needed	Unread; access not attempted	Not read	Group, night and endpoint denominators, absolute and baseline values and changes, supportive findings, headache and other harm details are needed. No new calculations.
Funding/conflict-of-interest disclosures	External materials unread/needed	Unread; access not attempted	Not read	Original disclosures on NIH/NHLBI, developer device and study involvement, and author roles are currently unread.

Report counts versus independent study counts

Link Roth2018 active and sham groups, people, two nights, absolute, supportive and co-primary findings, and parent, latency and sleep-efficiency sheets within the same trial and reference. These are not added as new independent trials or participants.

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 · How is the selected sleep-efficiency claim distinguished from the related latency claim?

Required materials and conditions: Sleep-efficiency question and verdict record versus parent and latency context
Conditions for verification: Distinguish original information on Sleep-efficiency question and verdict record versus parent and latency context from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Related claims and co-primary context do not add new units to the selected question.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How is the selected sleep-efficiency claim distinguished from the related latency claim?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application

N02 · What are the subclaim grade, note and absent values?

Required materials and conditions: Subclaim D and note, absent score, status and axes, and parent history
Conditions for verification: Distinguish original information on Subclaim D and note, absent score, status and axes, and parent history from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Parent 28 points and axes such as C0 are not transferred into subclaim scores or axes, or a passed current review.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the subclaim grade, note and absent values?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N03 · Which people with insomnia were studied?

Required materials and conditions: Diagnosed adults with insomnia and recruitment and baseline scope
Conditions for verification: Distinguish original information on Diagnosed adults with insomnia and recruitment and baseline scope from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Efficacy is not newly extended to other sleep disorders, vulnerable populations or the general population.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Which people with insomnia were studied?
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

N04 · Were comorbidities, medications and baseline sleep established?

Required materials and conditions: Baseline insomnia, medication and concurrent treatment, and assessment criteria
Conditions for verification: Distinguish original information on Baseline insomnia, medication and concurrent treatment, and assessment criteria from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Use, discontinuation or replacement of sleep medication or other treatments is not added to the original study.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were comorbidities, medications and baseline sleep established?
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed

N05 · What distinguishes the active device from an ordinary cold pack?

Required materials and conditions: Device type, active temperature and study exposure
Conditions for verification: Distinguish original information on Device type, active temperature and study exposure from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: 14-16°C is not converted into instructions for device settings, forehead cooling or cold packs.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What distinguishes the active device from an ordinary cold pack?
Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed

N06 · What were the sham-device control conditions?

Required materials and conditions: Sham design, exposure and comparison, and feasibility of blinding
Conditions for verification: Distinguish original information on Sham design, exposure and comparison, and feasibility of blinding from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Sham is not substituted with no treatment, a specified temperature, or a direct comparison with sleep medication.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What were the sham-device control conditions?
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction markers and assessment adaptation are internally designed; M08 §8.1–8.2.3; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application

N07 · How are two-night exposure and measurement separated from lasting effects?

Required materials and conditions: Actual measurement nights, exposure duration, and baseline and follow-up schedules
Conditions for verification: Distinguish original information on Actual measurement nights, exposure duration, and baseline and follow-up schedules from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Two nights are not counted as separate independent trials or additional participants, or extended into ongoing-use effects.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are two-night exposure and measurement separated from lasting effects?
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

N08 · How is absolute sleep efficiency defined and measured by PSG?

Required materials and conditions: Sleep-efficiency definition, measurement and calculation units, and assessment procedures
Conditions for verification: Distinguish original information on Sleep-efficiency definition, measurement and calculation units, and assessment procedures from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Percentage points are not converted into relative percentages, minutes asleep or individual efficacy.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How is absolute sleep efficiency defined and measured by PSG?
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed

N09 · What are the original sleep-efficiency between-group difference, CI and P value?

Required materials and conditions: Original comparison of +0.5 percentage points, 95% CI -3.4 to 4.5, P=.759
Conditions for verification: Distinguish original information on Original comparison of +0.5 percentage points, 95% CI -3.4 to 4.5, P=.759 from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: The original null result is not newly judged as an exactly zero effect, equivalence or nonresponse in every person.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the original sleep-efficiency between-group difference, CI and P value?
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

N10 · Were group-specific absolute, baseline and final values and changes established?

Required materials and conditions: Group-specific sleep efficiency, baseline, final values and changes, and adjustment
Conditions for verification: Distinguish original information on Group-specific sleep efficiency, baseline, final values and changes, and adjustment from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: The between-group +0.5 percentage points is not copied as each group's change or an individual's increase.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were group-specific absolute, baseline and final values and changes established?
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

N11 · How are the original CI and null statement separated from importance?

Required materials and conditions: Precision, importance, the original null result and clinical interpretation
Conditions for verification: Distinguish original information on Precision, importance, the original null result and clinical interpretation from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: A P value alone does not create new precision certification or equivalence or safety judgments.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are the original CI and null statement separated from importance?
Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

N12 · What is the context of the related absolute-latency claim?

Required materials and conditions: Different units and effects for latency and selected sleep efficiency
Conditions for verification: Distinguish original information on Different units and effects for latency and selected sleep efficiency from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: Related findings and the same report are not added as new independent trials or participants.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What is the context of the related absolute-latency claim?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internal extension boundaries

N13 · What are the relative-latency and sleep-stage supportive findings?

Required materials and conditions: Relative persistent-sleep latency and entry to stages 1 and 2 versus the selected finding
Conditions for verification: Distinguish original information on Relative persistent-sleep latency and entry to stages 1 and 2 versus the selected finding from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: Positive supportive latency findings are not converted into success of the absolute sleep-efficiency co-primary endpoint or efficacy of replacing treatment.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the relative-latency and sleep-stage supportive findings?
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4; internally defined extension boundaries

N14 · Were other sleep outcomes, symptoms and quality of life established?

Required materials and conditions: Objective selected endpoints versus subjective and everyday outcomes
Conditions for verification: Distinguish original information on Objective selected endpoints versus subjective and everyday outcomes from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: PSG or supportive findings are not promoted into established overall sleep or insomnia-treatment success.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were other sleep outcomes, symptoms and quality of life established?
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension

N15 · Are original prespecified co-primary statements separated from reading external plans?

Required materials and conditions: Original co-primary hierarchy for absolute persistent-sleep latency and absolute sleep efficiency
Conditions for verification: Distinguish original information on Original co-primary hierarchy for absolute persistent-sleep latency and absolute sleep efficiency from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Unread external material does not erase the original prespecification statement or create current prespecification certification.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Are original prespecified co-primary statements separated from reading external plans?
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application

N16 · What separates the registration identifier from actual registration and plan content?

Required materials and conditions: Original NCT01966211 identifier versus versions, dates and reading
Conditions for verification: Distinguish original information on Original NCT01966211 identifier versus versions, dates and reading from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: The original identifier and historical Codex full-text cross-check are not promoted into current reading or verification of registration content.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What separates the registration identifier from actual registration and plan content?
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

N17 · Were supportive and exploratory findings, multiplicity and selective reporting addressed?

Required materials and conditions: Positive supportive findings after primary failure, multiplicity and prespecified analyses
Conditions for verification: Distinguish original information on Positive supportive findings after primary failure, multiplicity and prespecified analyses from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Positive supportive findings alone do not replace the selected sleep-efficiency failure or create a new effect judgment.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were supportive and exploratory findings, multiplicity and selective reporting addressed?
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application

N18 · Were randomization, allocation concealment and blinding established?

Required materials and conditions: Actual procedures for the prospective randomized sham comparison
Conditions for verification: Distinguish original information on Actual procedures for the prospective randomized sham comparison from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: The name sham-controlled does not certify successful blinding or absence of bias.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were randomization, allocation concealment and blinding established?
Referenced methods: M08 §8.1–8.2.3; own application

N19 · What are total 106 and group- and outcome-specific allocation and denominators?

Required materials and conditions: Overall allocation versus completion, analysis, and night- and endpoint-specific denominators
Conditions for verification: Distinguish original information on Overall allocation versus completion, analysis, and night- and endpoint-specific denominators from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: 106 participants are not divided into invented group allocations, and two-night observations are not added as new participants.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are total 106 and group- and outcome-specific allocation and denominators?
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N20 · What are the analysis units for nights, baseline and repeated measurements, and people?

Required materials and conditions: Nights and visits in the same participants, effects of interest and correlation
Conditions for verification: Distinguish original information on Nights and visits in the same participants, effects of interest and correlation from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Two-night findings are not duplicated to increase replication counts or sample size.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the analysis units for nights, baseline and repeated measurements, and people?
Referenced methods: Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application

N21 · How are withdrawal, incomplete assessments, ineligible PSG and missing data handled?

Required materials and conditions: Missing participants and nights, reasons for missingness and discontinuation, and handling
Conditions for verification: Distinguish original information on Missing participants and nights, reasons for missingness and discontinuation, and handling from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Absent material is not declared zero withdrawal, complete two-night participation, ITT or PP.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are withdrawal, incomplete assessments, ineligible PSG and missing data handled?
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application

N22 · Are within-group, between-group, adjusted, absolute and change effects distinguished?

Required materials and conditions: Original between-group contrast versus each group's changes, adjustment and models
Conditions for verification: Distinguish original information on Original between-group contrast versus each group's changes, adjustment and models from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: +0.5 percentage points and -7.9 minutes are not transferred into other effects or denominators or newly analyzed.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Are within-group, between-group, adjusted, absolute and change effects distinguished?
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

N23 · What are actual device exposure, adherence, deviations and concurrent treatment?

Required materials and conditions: Actual device operation, wearing, discontinuation and shared conditions
Conditions for verification: Distinguish original information on Actual device operation, wearing, discontinuation and shared conditions from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Original device exposure is not turned into implementation or sleep and insomnia treatment-replacement instructions.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are actual device exposure, adherence, deviations and concurrent treatment?
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed

N24 · What original information describes developer and public support and author interests?

Required materials and conditions: NIH/NHLBI and Ebb Therapeutics support and author roles
Conditions for verification: Distinguish original information on NIH/NHLBI and Ebb Therapeutics support and author roles from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Original historical I0 and B2 are not inherited as new review findings, and support information alone does not change judgments on the figures.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What original information describes developer and public support and author interests?
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application

N25 · How are reports, trials, related claims, nights and groups linked within the same family?

Required materials and conditions: The single Roth2018 reference and trial versus duplicate observations
Conditions for verification: Distinguish original information on The single Roth2018 reference and trial versus duplicate observations from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: One report entry is not certification of a final count of clinical independence.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are reports, trials, related claims, nights and groups linked within the same family?
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N26 · What independent confirmation or replication supports selected sleep efficiency?

Required materials and conditions: Direct independent research on the same absolute sleep-efficiency question
Conditions for verification: Distinguish original information on Direct independent research on the same absolute sleep-efficiency question from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: An original single-trial statement is not converted into verification of no current research worldwide, and related sheets are not counted as independent replication.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What independent confirmation or replication supports selected sleep efficiency?
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N27 · Can findings apply to other devices, populations, durations or subgroups?

Required materials and conditions: Extrapolation beyond the original device and population to general cooling and subgroups
Conditions for verification: Distinguish original information on Extrapolation beyond the original device and population to general cooling and subgroups from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: No new claims of null effects for every cooling method, specific-population benefits, or device recommendations and use instructions are created.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Can findings apply to other devices, populations, durations or subgroups?
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are internally designed

N28 · Are PSG findings distinguished from long-term and patient-important insomnia effects?

Required materials and conditions: Two-night objective measures versus symptoms, everyday function and persistence
Conditions for verification: Distinguish original information on Two-night objective measures versus symptoms, everyday function and persistence from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: Positive supportive latency findings are not extended into drug-like efficacy, replacement of treatment or long-term success.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Are PSG findings distinguished from long-term and patient-important insomnia effects?
Referenced methods: M03 §3.2.4; internally defined extension boundaries; M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are internally designed

N29 · What has actually been obtained and read, and what do URLs and registration links mean?

Required materials and conditions: Local stored summary versus external abstract, full text and plans
Conditions for verification: Distinguish original information on Local stored summary versus external abstract, full text and plans from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Presence of a URL, PMCID or NCT identifier is not presented as external acquisition, reading or a successful link check.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What has actually been obtained and read, and what do URLs and registration links mean?
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N30 · How are Korean and English texts, dates, corrections, empty values and historical axes preserved?

Required materials and conditions: Original language texts, dates, corrections, axes and verification statements
Conditions for verification: Distinguish original information on Original language texts, dates, corrections, axes and verification statements from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Required
Application exceptions: Historical Codex full-text cross-checking is not inherited as passed current clinical review or external reading.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are Korean and English texts, dates, corrections, empty values and historical axes preserved?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item

N31 · Were adverse-event collection, definitions and scope established?

Required materials and conditions: Active and passive collection, event definitions, severity and discontinuation
Conditions for verification: Distinguish original information on Active and passive collection, event definitions, severity and discontinuation from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: A statement of similar patterns is not converted into zero harms, equivalent safety or absence of every risk.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were adverse-event collection, definitions and scope established?
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP

N32 · Which group, event and denominator does the headache report refer to?

Required materials and conditions: Headache groups, people, events, attribution and denominators
Conditions for verification: Distinguish original information on Headache groups, people, events, attribution and denominators from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: Headache is not transferred into a confirmed active-group event, and absent counts or incidence rates are not invented.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Which group, event and denominator does the headache report refer to?
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are internally designed; M19 §19.1.2–19.2.4; Internal application; Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool

N33 · What are short-term harm-comparison denominators, differences and CIs?

Required materials and conditions: Group-specific collection populations, event and exposure denominators, and comparisons
Conditions for verification: Distinguish original information on Group-specific collection populations, event and exposure denominators, and comparisons from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: 106 participants and two nights are not automatically used as valid harm denominators or declared equivalence or zero difference.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are short-term harm-comparison denominators, differences and CIs?
Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application

N34 · What are harm timing and delayed or long-term findings after two nights?

Required materials and conditions: Exposure and event timing and post-discontinuation follow-up
Conditions for verification: Distinguish original information on Exposure and event timing and post-discontinuation follow-up from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: Similar two-night tolerability is not extended into safety of repeated or long-term use.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are harm timing and delayed or long-term findings after two nights?
Referenced methods: M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application

N35 · What links harms to the device, sham, medical history or medications?

Required materials and conditions: Temperature, pressure and other exposure, alternative causes and concurrent conditions
Conditions for verification: Distinguish original information on Temperature, pressure and other exposure, alternative causes and concurrent conditions from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: Pressure, skin injury, causes, prevention or care absent from the summary are not added as new clinical facts.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What links harms to the device, sham, medical history or medications?
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

N36 · Were harm-related discontinuation and missing PSG established?

Required materials and conditions: Discontinuation and missingness reasons, completion of harm collection and denominators
Conditions for verification: Distinguish original information on Discontinuation and missingness reasons, completion of harm collection and denominators from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: Absent material is not converted into zero discontinuation, zero missingness or safety of every completer.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were harm-related discontinuation and missing PSG established?
Referenced methods: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application

N37 · Was independent harm evidence or separate event material obtained?

Required materials and conditions: Independent harm reports for the same device, population and duration
Conditions for verification: Distinguish original information on Independent harm reports for the same device, population and duration from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: No separate current entry does not establish absence of every external harm report.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Was independent harm evidence or separate event material obtained?
Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

N38 · What is known about safety in vulnerable populations, other diseases and repeated exposure?

Required materials and conditions: Population- and disease-specific and long-term device-safety scope
Conditions for verification: Distinguish original information on Population- and disease-specific and long-term device-safety scope from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: No new eligibility, device-setting, cooling, sleep-care or insomnia-treatment instructions are created.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What is known about safety in vulnerable populations, other diseases and repeated exposure?
Referenced methods: M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed

N39 · How are null PSG efficacy and safety or causal judgments separated?

Required materials and conditions: Separation of sleep efficiency, harm comparisons, original caution and causality
Conditions for verification: Distinguish original information on Separation of sleep efficiency, harm comparisons, original caution and causality from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: Null sleep efficiency is not converted into safety benefits or harms, or treatment-replacement instructions.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are null PSG efficacy and safety or causal judgments separated?
Referenced methods: Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries

N40 · How are subsequent material, condition versions, historical candidates and incomplete review linked?

Required materials and conditions: Identity, units and denominators, outcome hierarchy, reading and change events, and original candidates
Conditions for verification: Distinguish original information on Identity, units and denominators, outcome hierarchy, reading and change events, and original candidates from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Requirement and applicability: Supplementary
Application exceptions: Historical full-text cross-checking or completed production is not invented as current model or clinical content review or completed publication.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are subsequent material, condition versions, historical candidates and incomplete review linked?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

What the statuses mean

Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
Review incomplete: Review of existing content or actual review incomplete.
Not reported: Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
Inaccessible: Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
Insufficient evidence for the conditions: Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
Not applicable: Used when the reason it does not apply to the original question is stated.
Conflicting data: Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

Change history

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

The public page and data were prepared from the existing 40 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.

View all item details

N01 · How is the selected sleep-efficiency claim distinguished from the related latency claim?

Current findings: The selected existing question is improved absolute sleep efficiency. Its subclaim record is linked while improved absolute latency to persistent sleep and parent context are retained. These are not counted as new questions, subdivisions or trials.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Clinical independence has not been newly certified.
Reason for missing information: Clinical independence was not newly certified.
Required materials and conditions: Sleep-efficiency question and verdict record versus parent and latency context
Materials to obtain first: Original question, device, population, comparator and endpoint, and scope-change records
Further research: A prespecified plan distinguishing sleep-efficiency and latency effects of interest
Remaining uncertainty: Clinical independence was not newly certified.
Conditions for verification: Distinguish original information on Sleep-efficiency question and verdict record versus parent and latency context from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How is the selected sleep-efficiency claim distinguished from the related latency claim?
Application exceptions: Related claims and co-primary context do not add new units to the selected question.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application

Related sources R01

N02 · What are the subclaim grade, note and absent values?

Current findings: The selected grade D and original note that P=.759 was null are retained. Subclaim score, status and axes fields are absent; parent D with 28 points and axes are separate historical values.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. The original subclaim lacks a score, status and axes.
Reason for missing information: Subclaim score/status/axes are absent in the original.
Required materials and conditions: Subclaim D and note, absent score, status and axes, and parent history
Materials to obtain first: Original subclaim and an explicit change event
Further research: Records separating existing grades and values from updates with additional evidence
Remaining uncertainty: Subclaim score/status/axes are absent in the original.
Conditions for verification: Distinguish original information on Subclaim D and note, absent score, status and axes, and parent history from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the subclaim grade, note and absent values?
Application exceptions: Parent 28 points and axes such as C0 are not transferred into subclaim scores or axes, or a passed current review.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources R01

N03 · Which people with insomnia were studied?

Current findings: The original research description records randomization of 106 adults with diagnosed insomnia to active or sham devices. This is not direct material for every sleep problem or other disease population.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Exact diagnostic criteria, duration, severity, inclusion and exclusion criteria, and demographic characteristics are unverified.
Reason for missing information: Exact diagnostic criteria, duration, severity, inclusion and exclusion criteria, and demographic characteristics are unverified.
Required materials and conditions: Diagnosed adults with insomnia and recruitment and baseline scope
Materials to obtain first: Diagnostic and eligibility records and baseline tables
Further research: Research specifying the population with insomnia
Remaining uncertainty: Exact diagnostic criteria, duration, severity, inclusion and exclusion criteria, and demographic characteristics are unverified.
Conditions for verification: Distinguish original information on Diagnosed adults with insomnia and recruitment and baseline scope from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Which people with insomnia were studied?
Application exceptions: Efficacy is not newly extended to other sleep disorders, vulnerable populations or the general population.
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

Related sources R01

N04 · Were comorbidities, medications and baseline sleep established?

Current findings: The original summary does not separately present baseline sleep efficiency or latency, medications, comorbidities, or selection and control of other treatments.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Baseline sleep, medical history and medications, concurrent treatment and between-group differences are unverified.
Reason for missing information: Baseline sleep, medical history and medications, concurrent treatment and between-group differences are unverified.
Required materials and conditions: Baseline insomnia, medication and concurrent treatment, and assessment criteria
Materials to obtain first: Baseline assessments, medication and treatment, and eligibility records
Further research: Research specifying shared conditions and concurrent treatment
Remaining uncertainty: Baseline sleep, medical history and medications, concurrent treatment and between-group differences are unverified.
Conditions for verification: Distinguish original information on Baseline insomnia, medication and concurrent treatment, and assessment criteria from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were comorbidities, medications and baseline sleep established?
Application exceptions: Use, discontinuation or replacement of sleep medication or other treatments is not added to the original study.
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed

Related sources R01

N05 · What distinguishes the active device from an ordinary cold pack?

Current findings: The original device delivered frontal thermal therapy regulating forehead temperature at 14-16°C. The existing study-conditions description records that it is not the same intervention as an ordinary cold pack.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Device model and components, wearing and operating duration, temperature measurement and actual adherence are unverified.
Reason for missing information: Device model and components, wearing and operating duration, temperature measurement and actual adherence are unverified.
Required materials and conditions: Device type, active temperature and study exposure
Materials to obtain first: Device specifications and actual study exposure and adherence
Further research: Research specifying the device and active exposure
Remaining uncertainty: Device model and components, wearing and operating duration, temperature measurement and actual adherence are unverified.
Conditions for verification: Distinguish original information on Device type, active temperature and study exposure from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What distinguishes the active device from an ordinary cold pack?
Application exceptions: 14-16°C is not converted into instructions for device settings, forehead cooling or cold packs.
Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed

Related sources R01

N06 · What were the sham-device control conditions?

Current findings: The original records a randomized comparison of active cooling and a sham device. Sham temperature, sensation, appearance, operation and blinding details are not presented.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Sham specifications, actual adherence, recognition of conditions and shared procedures are unverified.
Reason for missing information: Sham specifications, actual adherence, recognition of conditions and shared procedures are unverified.
Required materials and conditions: Sham design, exposure and comparison, and feasibility of blinding
Materials to obtain first: Active and sham specifications and condition-recognition and procedure material
Further research: Research specifying the sham intervention and comparison of interest
Remaining uncertainty: Sham specifications, actual adherence, recognition of conditions and shared procedures are unverified.
Conditions for verification: Distinguish original information on Sham design, exposure and comparison, and feasibility of blinding from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What were the sham-device control conditions?
Application exceptions: Sham is not substituted with no treatment, a specified temperature, or a direct comparison with sleep medication.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction markers and assessment adaptation are internally designed; M08 §8.1–8.2.3; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application

Related sources R01

N07 · How are two-night exposure and measurement separated from lasting effects?

Current findings: The original records 106 participants and two nights of assessment and efficacy follow-up. Night-specific values, order, baseline or adaptation nights, and long-term or post-treatment follow-up details are absent from the summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Each night's and baseline assessment schedules, analytical aggregation and long-term outcomes are unverified.
Reason for missing information: Each night's and baseline assessment schedules, analytical aggregation and long-term outcomes are unverified.
Required materials and conditions: Actual measurement nights, exposure duration, and baseline and follow-up schedules
Materials to obtain first: Measurement and exposure schedules and night-specific result tables
Further research: Research distinguishing baseline, measurement nights and follow-up in advance
Remaining uncertainty: Each night's and baseline assessment schedules, analytical aggregation and long-term outcomes are unverified.
Conditions for verification: Distinguish original information on Actual measurement nights, exposure duration, and baseline and follow-up schedules from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are two-night exposure and measurement separated from lasting effects?
Application exceptions: Two nights are not counted as separate independent trials or additional participants, or extended into ongoing-use effects.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

Related sources R01

N08 · How is absolute sleep efficiency defined and measured by PSG?

Current findings: The original selected outcome is absolute sleep efficiency, described as one co-primary PSG endpoint. Its between-group result uses percentage points. Detailed formulas, PSG scoring and criteria are not presented.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Sleep-efficiency formulas and denominators, measurement, scoring and eligibility criteria are unverified.
Reason for missing information: Sleep-efficiency formulas and denominators, measurement, scoring and eligibility criteria are unverified.
Required materials and conditions: Sleep-efficiency definition, measurement and calculation units, and assessment procedures
Materials to obtain first: PSG methods, sleep-efficiency definitions and result tables
Further research: Research with explicit sleep-efficiency and measurement plans
Remaining uncertainty: Sleep-efficiency formulas and denominators, measurement, scoring and eligibility criteria are unverified.
Conditions for verification: Distinguish original information on Sleep-efficiency definition, measurement and calculation units, and assessment procedures from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How is absolute sleep efficiency defined and measured by PSG?
Application exceptions: Percentage points are not converted into relative percentages, minutes asleep or individual efficacy.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed

Related sources R01

N09 · What are the original sleep-efficiency between-group difference, CI and P value?

Current findings: The original reader answer records an absolute sleep-efficiency between-group difference of +0.5 percentage points (95% CI -3.4 to 4.5), P=.759. The null statement in the selected subclaim note is retained; no new effect or CI is calculated.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Detailed models, adjustment, denominators and aggregation of measurement nights for the contrast direction are unverified.
Reason for missing information: Detailed models, adjustment, denominators and aggregation of measurement nights for the contrast direction are unverified.
Required materials and conditions: Original comparison of +0.5 percentage points, 95% CI -3.4 to 4.5, P=.759
Materials to obtain first: Analysis models and absolute sleep-efficiency result and denominator tables
Further research: Research prespecifying effects of interest, intervals and measurement nights
Remaining uncertainty: Detailed models, adjustment, denominators and aggregation of measurement nights for the contrast direction are unverified.
Conditions for verification: Distinguish original information on Original comparison of +0.5 percentage points, 95% CI -3.4 to 4.5, P=.759 from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the original sleep-efficiency between-group difference, CI and P value?
Application exceptions: The original null result is not newly judged as an exactly zero effect, equivalence or nonresponse in every person.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources R01

N10 · Were group-specific absolute, baseline and final values and changes established?

Current findings: The current summary provides the absolute sleep-efficiency between-group difference, but does not separately provide each group's absolute values, baseline values, changes from baseline or night-specific values.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Group- and night-specific absolute values, baseline values and changes, variance, CIs and adjustment are unverified.
Reason for missing information: Group- and night-specific absolute values, baseline values and changes, variance, CIs and adjustment are unverified.
Required materials and conditions: Group-specific sleep efficiency, baseline, final values and changes, and adjustment
Materials to obtain first: Baseline, each night's and group-specific findings and analysis tables
Further research: Plans distinguishing absolute values and changes, and within-group and between-group comparisons
Remaining uncertainty: Group- and night-specific absolute values, baseline values and changes, variance, CIs and adjustment are unverified.
Conditions for verification: Distinguish original information on Group-specific sleep efficiency, baseline, final values and changes, and adjustment from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were group-specific absolute, baseline and final values and changes established?
Application exceptions: The between-group +0.5 percentage points is not copied as each group's change or an individual's increase.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources R01

N11 · How are the original CI and null statement separated from importance?

Current findings: Original CIs and P values are retained. Parent precision C0 and effect E0 are historical axes. Clinical importance, equivalence margins and individual responses have not been separately established.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Importance criteria, prespecified power and equivalence margins, and model details are unverified.
Reason for missing information: Importance criteria, prespecified power and equivalence margins, and model details are unverified.
Required materials and conditions: Precision, importance, the original null result and clinical interpretation
Materials to obtain first: Effect, importance and testing plans, and original findings
Further research: Research prespecifying intervals, importance and effects of interest
Remaining uncertainty: Importance criteria, prespecified power and equivalence margins, and model details are unverified.
Conditions for verification: Distinguish original information on Precision, importance, the original null result and clinical interpretation from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are the original CI and null statement separated from importance?
Application exceptions: A P value alone does not create new precision certification or equivalence or safety judgments.
Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design

Related sources R01

N12 · What is the context of the related absolute-latency claim?

Current findings: The latency sheet has grade D and a null P=.092; the original parent between-group difference is -7.9 minutes (95% CI -18.4 to 2.6), P=.092. This remains a latency result and is not transferred into selected sleep efficiency in percentage points.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Latency definitions, individual and night-specific values, and model details are unverified.
Reason for missing information: Latency definitions, individual and night-specific values, and model details are unverified.
Required materials and conditions: Different units and effects for latency and selected sleep efficiency
Materials to obtain first: Separate definitions, denominators and result tables for each endpoint
Further research: Plans distinguishing latency and sleep efficiency
Remaining uncertainty: Latency definitions, individual and night-specific values, and model details are unverified.
Conditions for verification: Distinguish original information on Different units and effects for latency and selected sleep efficiency from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What is the context of the related absolute-latency claim?
Application exceptions: Related findings and the same report are not added as new independent trials or participants.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internal extension boundaries

Related sources R01

N13 · What are the relative-latency and sleep-stage supportive findings?

Current findings: The original states that relative latency to persistent sleep and some latencies to stages 1 and 2 favored treatment in supportive analyses. Exact values, CIs, denominators and analysis hierarchy are absent from the summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Exact definitions, effects, CIs, prespecified or exploratory plans, and denominators for supportive findings are unverified.
Reason for missing information: Exact definitions, effects, CIs, prespecified or exploratory plans, and denominators for supportive findings are unverified.
Required materials and conditions: Relative persistent-sleep latency and entry to stages 1 and 2 versus the selected finding
Materials to obtain first: Supportive-result tables and protocol and SAP hierarchy
Further research: Confirmatory research separating primary, secondary and exploratory findings
Remaining uncertainty: Exact definitions, effects, CIs, prespecified or exploratory plans, and denominators for supportive findings are unverified.
Conditions for verification: Distinguish original information on Relative persistent-sleep latency and entry to stages 1 and 2 versus the selected finding from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the relative-latency and sleep-stage supportive findings?
Application exceptions: Positive supportive latency findings are not converted into success of the absolute sleep-efficiency co-primary endpoint or efficacy of replacing treatment.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4; internally defined extension boundaries

Related sources R01

N14 · Were other sleep outcomes, symptoms and quality of life established?

Current findings: The current summary's main findings concern PSG latency, sleep efficiency and supportive latency measures. Separate direct figures for subjective insomnia symptoms, quality of life, daytime function and other sleep outcomes are absent.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Those outcome definitions, effects, CIs, denominators and duration are unverified.
Reason for missing information: Those outcome definitions, effects, CIs, denominators and duration are unverified.
Required materials and conditions: Objective selected endpoints versus subjective and everyday outcomes
Materials to obtain first: Subjective and patient-important outcomes and analysis tables
Further research: Plans distinguishing PSG, symptoms and function
Remaining uncertainty: Those outcome definitions, effects, CIs, denominators and duration are unverified.
Conditions for verification: Distinguish original information on Objective selected endpoints versus subjective and everyday outcomes from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were other sleep outcomes, symptoms and quality of life established?
Application exceptions: PSG or supportive findings are not promoted into established overall sleep or insomnia-treatment success.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension

Related sources R01

N15 · Are original prespecified co-primary statements separated from reading external plans?

Current findings: The original evidence and Korean and English texts record two PSG endpoints as prespecified co-primary outcomes and describe both as null. This original hierarchy is retained, without new reading or certification of external plans.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Actual hierarchy, dates and success rules in registration versions, protocols and SAPs have not been read.
Reason for missing information: Actual hierarchy, dates and success rules in registration versions, protocols and SAPs have not been read.
Required materials and conditions: Original co-primary hierarchy for absolute persistent-sleep latency and absolute sleep efficiency
Materials to obtain first: Original registration, protocol and SAP versions and outcome plans
Further research: Research specifying co-primary outcomes and success criteria
Remaining uncertainty: Actual hierarchy, dates and success rules in registration versions, protocols and SAPs have not been read.
Conditions for verification: Distinguish original information on Original co-primary hierarchy for absolute persistent-sleep latency and absolute sleep efficiency from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Are original prespecified co-primary statements separated from reading external plans?
Application exceptions: Unread external material does not erase the original prespecification statement or create current prespecification certification.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application

Related sources R01

N16 · What separates the registration identifier from actual registration and plan content?

Current findings: NCT01966211 in the evidence and citation is linked in its original form. External registration, protocol and SAP have not been newly retrieved or read.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Actual registration content, amendments, versions, dates and plans are unverified.
Reason for missing information: Actual registration content, amendments, versions, dates and plans are unverified.
Required materials and conditions: Original NCT01966211 identifier versus versions, dates and reading
Materials to obtain first: Original registration versions, protocol and SAP
Further research: Records linking plan amendments and published findings
Remaining uncertainty: Actual registration content, amendments, versions, dates and plans are unverified.
Conditions for verification: Distinguish original information on Original NCT01966211 identifier versus versions, dates and reading from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What separates the registration identifier from actual registration and plan content?
Application exceptions: The original identifier and historical Codex full-text cross-check are not promoted into current reading or verification of registration content.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

Related sources R01

N17 · Were supportive and exploratory findings, multiplicity and selective reporting addressed?

Current findings: The parent primary-failed and secondary-positive indicator is true, and null co-primary and positive supportive findings are retained as historical context. Whether supportive findings were prespecified secondary or exploratory analyses, and detailed multiplicity handling, remain unverified.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Supportive versus exploratory classification, testing lists, multiplicity and selective-reporting plans are unverified.
Reason for missing information: Supportive versus exploratory classification, testing lists, multiplicity and selective-reporting plans are unverified.
Required materials and conditions: Positive supportive findings after primary failure, multiplicity and prespecified analyses
Materials to obtain first: Protocol, SAP and complete result lists
Further research: Research fixing the hierarchy of primary, secondary and exploratory outcomes
Remaining uncertainty: Supportive versus exploratory classification, testing lists, multiplicity and selective-reporting plans are unverified.
Conditions for verification: Distinguish original information on Positive supportive findings after primary failure, multiplicity and prespecified analyses from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were supportive and exploratory findings, multiplicity and selective reporting addressed?
Application exceptions: Positive supportive findings alone do not replace the selected sleep-efficiency failure or create a new effect judgment.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application

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N18 · Were randomization, allocation concealment and blinding established?

Current findings: The original design is a prospective randomized sham-controlled trial. Allocation sequence, concealment, participant and assessor blinding, and recognition of conditions are not separately available in the summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Sequence generation, concealment, blinding, recognition of conditions and baseline balance are unverified.
Reason for missing information: Sequence generation, concealment, blinding, recognition of conditions and baseline balance are unverified.
Required materials and conditions: Actual procedures for the prospective randomized sham comparison
Materials to obtain first: Allocation and blinding material, baseline tables and protocol
Further research: Blinding and allocation plans for device-versus-sham comparisons
Remaining uncertainty: Sequence generation, concealment, blinding, recognition of conditions and baseline balance are unverified.
Conditions for verification: Distinguish original information on Actual procedures for the prospective randomized sham comparison from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were randomization, allocation concealment and blinding established?
Application exceptions: The name sham-controlled does not certify successful blinding or absence of bias.
Referenced methods: M08 §8.1–8.2.3; own application

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N19 · What are total 106 and group- and outcome-specific allocation and denominators?

Current findings: The original records randomization of 106 adults with insomnia and two nights. Group-specific allocation and completion, and analysis denominators for each PSG endpoint, night and model are not separately presented.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Group-specific flow, completion and analysis, and valid night and endpoint denominators are unverified.
Reason for missing information: Group-specific flow, completion and analysis, and valid night and endpoint denominators are unverified.
Required materials and conditions: Overall allocation versus completion, analysis, and night- and endpoint-specific denominators
Materials to obtain first: Participant flow and night- and outcome-specific analysis tables
Further research: Plans distinguishing allocation, people, nights and analysis populations
Remaining uncertainty: Group-specific flow, completion and analysis, and valid night and endpoint denominators are unverified.
Conditions for verification: Distinguish original information on Overall allocation versus completion, analysis, and night- and endpoint-specific denominators from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are total 106 and group- and outcome-specific allocation and denominators?
Application exceptions: 106 participants are not divided into invented group allocations, and two-night observations are not added as new participants.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

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N20 · What are the analysis units for nights, baseline and repeated measurements, and people?

Current findings: The original states two nights, but night-specific and aggregated effects, baseline adjustment and repeated-measures correlation handling are not detailed. Nights from the same person are not counted as independent people or trials.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Night-specific data, repeated-measures and aggregation methods, and baseline and period models are unverified.
Reason for missing information: Night-specific data, repeated-measures and aggregation methods, and baseline and period models are unverified.
Required materials and conditions: Nights and visits in the same participants, effects of interest and correlation
Materials to obtain first: Night-specific and baseline data and analysis plans
Further research: Research specifying repeated observations and participant-level effects of interest
Remaining uncertainty: Night-specific data, repeated-measures and aggregation methods, and baseline and period models are unverified.
Conditions for verification: Distinguish original information on Nights and visits in the same participants, effects of interest and correlation from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the analysis units for nights, baseline and repeated measurements, and people?
Application exceptions: Two-night findings are not duplicated to increase replication counts or sample size.
Referenced methods: Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application

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N21 · How are withdrawal, incomplete assessments, ineligible PSG and missing data handled?

Current findings: The original 106-person, two-night summary does not separately present group-specific withdrawal, incomplete or ineligible PSG, missing endpoints or handling methods.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Reasons for missingness and discontinuation, denominators, imputation, sensitivity analyses and analysis populations are unverified.
Reason for missing information: Reasons for missingness and discontinuation, denominators, imputation, sensitivity analyses and analysis populations are unverified.
Required materials and conditions: Missing participants and nights, reasons for missingness and discontinuation, and handling
Materials to obtain first: PSG eligibility, participant flow, missing-data handling and SAP
Further research: Research prespecifying missingness and effects of interest
Remaining uncertainty: Reasons for missingness and discontinuation, denominators, imputation, sensitivity analyses and analysis populations are unverified.
Conditions for verification: Distinguish original information on Missing participants and nights, reasons for missingness and discontinuation, and handling from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are withdrawal, incomplete assessments, ineligible PSG and missing data handled?
Application exceptions: Absent material is not declared zero withdrawal, complete two-night participation, ITT or PP.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application

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N22 · Are within-group, between-group, adjusted, absolute and change effects distinguished?

Current findings: The original reader answer provides between-group differences for absolute PSG endpoints. Within-group changes, adjustment models, change contrasts and relative supportive analyses are distinguished from these values.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Models, adjustment, baseline values, changes, within-group and between-group contrasts, and supportive definitions are unverified.
Reason for missing information: Models, adjustment, baseline values, changes, within-group and between-group contrasts, and supportive definitions are unverified.
Required materials and conditions: Original between-group contrast versus each group's changes, adjustment and models
Materials to obtain first: Definitions, denominators, models and SAP for each effect of interest
Further research: Research separating absolute values, changes, relative measures, within-group and between-group contrasts
Remaining uncertainty: Models, adjustment, baseline values, changes, within-group and between-group contrasts, and supportive definitions are unverified.
Conditions for verification: Distinguish original information on Original between-group contrast versus each group's changes, adjustment and models from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Are within-group, between-group, adjusted, absolute and change effects distinguished?
Application exceptions: +0.5 percentage points and -7.9 minutes are not transferred into other effects or denominators or newly analyzed.
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

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N23 · What are actual device exposure, adherence, deviations and concurrent treatment?

Current findings: Only original active exposure at 14-16°C, sham and two-night information are retained. Actual device operation, wearing, discontinuation, cross-use and concurrent sleep-treatment details are not presented.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Adherence, deviations, shared care, and medication and treatment changes are unverified.
Reason for missing information: Adherence, deviations, shared care, and medication and treatment changes are unverified.
Required materials and conditions: Actual device operation, wearing, discontinuation and shared conditions
Materials to obtain first: Device logs, exposure, shared treatment and deviation records
Further research: Research distinguishing actual exposure from assignment effects of interest
Remaining uncertainty: Adherence, deviations, shared care, and medication and treatment changes are unverified.
Conditions for verification: Distinguish original information on Actual device operation, wearing, discontinuation and shared conditions from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are actual device exposure, adherence, deviations and concurrent treatment?
Application exceptions: Original device exposure is not turned into implementation or sleep and insomnia treatment-replacement instructions.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed

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N24 · What original information describes developer and public support and author interests?

Current findings: Original funding information records NIH/NHLBI support, Ebb Therapeutics device and study involvement, and company founder and executive authorship. Public support does not erase developer involvement or guarantee independence.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Financial and in-kind support, design, analysis and data-access roles, and detailed disclosures are unverified.
Reason for missing information: Financial and in-kind support, design, analysis and data-access roles, and detailed disclosures are unverified.
Required materials and conditions: NIH/NHLBI and Ebb Therapeutics support and author roles
Materials to obtain first: Support, author-interest and role disclosures
Further research: Explicit reporting of support and design and analysis roles
Remaining uncertainty: Financial and in-kind support, design, analysis and data-access roles, and detailed disclosures are unverified.
Conditions for verification: Distinguish original information on NIH/NHLBI and Ebb Therapeutics support and author roles from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What original information describes developer and public support and author interests?
Application exceptions: Original historical I0 and B2 are not inherited as new review findings, and support information alone does not change judgments on the figures.
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application

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N25 · How are reports, trials, related claims, nights and groups linked within the same family?

Current findings: The Roth2018 report is linked through one existing evidence entry and one citation entry. Active and sham groups, two nights, co-primary and supportive outcomes, and latency and sleep-efficiency sheets share the same original context and are not added as new independent trials or participants.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Related report/trial relationships and unique trial/participant totals are unverified.
Reason for missing information: Related report/trial relationships and unique trial/participant totals are unverified.
Required materials and conditions: The single Roth2018 reference and trial versus duplicate observations
Materials to obtain first: Trial and report identity, related reports and observation units
Further research: Records distinguishing reports from study families
Remaining uncertainty: Related report/trial relationships and unique trial/participant totals are unverified.
Conditions for verification: Distinguish original information on The single Roth2018 reference and trial versus duplicate observations from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are reports, trials, related claims, nights and groups linked within the same family?
Application exceptions: One report entry is not certification of a final count of clinical independence.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

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N26 · What independent confirmation or replication supports selected sleep efficiency?

Current findings: The parent records the context of one small two-night trial and absent long-term confirmation. Other independent research has not been searched or verified here.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Populations, devices, endpoints, duplication and independence of separate direct reports are unverified.
Reason for missing information: Populations, devices, endpoints, duplication and independence of separate direct reports are unverified.
Required materials and conditions: Direct independent research on the same absolute sleep-efficiency question
Materials to obtain first: Direct confirmatory reports and trial identity
Further research: Separate confirmatory research addressing the same question
Remaining uncertainty: Populations, devices, endpoints, duplication and independence of separate direct reports are unverified.
Conditions for verification: Distinguish original information on Direct independent research on the same absolute sleep-efficiency question from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What independent confirmation or replication supports selected sleep efficiency?
Application exceptions: An original single-trial statement is not converted into verification of no current research worldwide, and related sheets are not counted as independent replication.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

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N27 · Can findings apply to other devices, populations, durations or subgroups?

Current findings: The material concerns the original device and adults with insomnia over two nights. Direct effects or durations for other devices, ordinary cold packs, ages, diseases or baseline-sleep groups are not presented.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Direct population, device, subgroup and long-term findings and interactions are unverified.
Reason for missing information: Direct population, device, subgroup and long-term findings and interactions are unverified.
Required materials and conditions: Extrapolation beyond the original device and population to general cooling and subgroups
Materials to obtain first: Direct population- and device-specific material and prespecified subgroup plans
Further research: Research specifying direct applicability
Remaining uncertainty: Direct population, device, subgroup and long-term findings and interactions are unverified.
Conditions for verification: Distinguish original information on Extrapolation beyond the original device and population to general cooling and subgroups from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Can findings apply to other devices, populations, durations or subgroups?
Application exceptions: No new claims of null effects for every cooling method, specific-population benefits, or device recommendations and use instructions are created.
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are internally designed

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N28 · Are PSG findings distinguished from long-term and patient-important insomnia effects?

Current findings: Current PSG sleep-efficiency and latency material and supportive signals have a short-term scope. Long-term insomnia course, daytime function, quality of life and treatment-replacement effects require separate material.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Direct persistence, post-discontinuation, patient-important and treatment-replacement outcomes are unverified.
Reason for missing information: Direct persistence, post-discontinuation, patient-important and treatment-replacement outcomes are unverified.
Required materials and conditions: Two-night objective measures versus symptoms, everyday function and persistence
Materials to obtain first: Long-term and patient-important outcomes and follow-up
Further research: Research separating PSG from long-term clinical questions
Remaining uncertainty: Direct persistence, post-discontinuation, patient-important and treatment-replacement outcomes are unverified.
Conditions for verification: Distinguish original information on Two-night objective measures versus symptoms, everyday function and persistence from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Are PSG findings distinguished from long-term and patient-important insomnia effects?
Application exceptions: Positive supportive latency findings are not extended into drug-like efficacy, replacement of treatment or long-term success.
Referenced methods: M03 §3.2.4; internally defined extension boundaries; M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are internally designed

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N29 · What has actually been obtained and read, and what do URLs and registration links mean?

Current findings: The complete stored verdict 2982 summary was read for production and saved as a copy. Original PubMed URL, PMCID and NCT identifiers link sources; external content and links have not been newly accessed or verified.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Current verification of detailed external original methods, findings, registration and plans is incomplete.
Reason for missing information: Current verification of detailed external original methods, findings, registration and plans is incomplete.
Required materials and conditions: Local stored summary versus external abstract, full text and plans
Materials to obtain first: Obtained original material and actual reading and update events
Further research: Records separating summary preservation from new acquisition and reading
Remaining uncertainty: Current verification of detailed external original methods, findings, registration and plans is incomplete.
Conditions for verification: Distinguish original information on Local stored summary versus external abstract, full text and plans from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What has actually been obtained and read, and what do URLs and registration links mean?
Application exceptions: Presence of a URL, PMCID or NCT identifier is not presented as external acquisition, reading or a successful link check.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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N30 · How are Korean and English texts, dates, corrections, empty values and historical axes preserved?

Current findings: Complete Korean and English texts, reference date 2026-09-07, an empty correction array, empty deliberation string and parent D with 28 points are retained. Axes B/S/R1/I0/E0/B2/C0, a true primary-failed and secondary-positive indicator, three other false indicators, and empty grade-override reasons are history.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Detailed external translation and comparisons with original texts, corrections and registration were not performed here.
Reason for missing information: Detailed external translation and comparisons with original texts, corrections and registration were not performed here.
Required materials and conditions: Original language texts, dates, corrections, axes and verification statements
Materials to obtain first: Original texts, language-specific changes, dates and correction events
Further research: Separation of original-value preservation from new evidence and changes
Remaining uncertainty: Detailed external translation and comparisons with original texts, corrections and registration were not performed here.
Conditions for verification: Distinguish original information on Original language texts, dates, corrections, axes and verification statements from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are Korean and English texts, dates, corrections, empty values and historical axes preserved?
Application exceptions: Historical Codex full-text cross-checking is not inherited as passed current clinical review or external reading.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item

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N31 · Were adverse-event collection, definitions and scope established?

Current findings: The safety description records broadly similar adverse-event patterns to sham over two nights, with headache and other events reported. Collection, classification, severity and the full event scope are not detailed.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Collection, definitions, severity, complete harm events and discontinuation tables are unverified.
Reason for missing information: Collection, definitions, severity, complete harm events and discontinuation tables are unverified.
Required materials and conditions: Active and passive collection, event definitions, severity and discontinuation
Materials to obtain first: Harm-collection plans and complete event and discontinuation tables
Further research: Research specifying harm collection separately from efficacy
Remaining uncertainty: Collection, definitions, severity, complete harm events and discontinuation tables are unverified.
Conditions for verification: Distinguish original information on Active and passive collection, event definitions, severity and discontinuation from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were adverse-event collection, definitions and scope established?
Application exceptions: A statement of similar patterns is not converted into zero harms, equivalent safety or absence of every risk.
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP

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N32 · Which group, event and denominator does the headache report refer to?

Current findings: The original states only that headache and other events were reported. Active or sham group, numbers of people and events, severity and attribution are not separately established in the summary.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Group-specific headache counts, valid denominators, severity, causality and timing are unverified.
Reason for missing information: Group-specific headache counts, valid denominators, severity, causality and timing are unverified.
Required materials and conditions: Headache groups, people, events, attribution and denominators
Materials to obtain first: Headache and other event tables, collection denominators and attribution records
Further research: Harm research with explicit event, person and exposure units
Remaining uncertainty: Group-specific headache counts, valid denominators, severity, causality and timing are unverified.
Conditions for verification: Distinguish original information on Headache groups, people, events, attribution and denominators from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Which group, event and denominator does the headache report refer to?
Application exceptions: Headache is not transferred into a confirmed active-group event, and absent counts or incidence rates are not invented.
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are internally designed; M19 §19.1.2–19.2.4; Internal application; Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool

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N33 · What are short-term harm-comparison denominators, differences and CIs?

Current findings: The original records broadly similar acute tolerability to sham. Group-specific harm-collection and event denominators, effects, CIs and equivalence tests are not presented.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Group- and night-specific harm denominators, events, exposure and comparison CIs are unverified.
Reason for missing information: Group- and night-specific harm denominators, events, exposure and comparison CIs are unverified.
Required materials and conditions: Group-specific collection populations, event and exposure denominators, and comparisons
Materials to obtain first: Harm-flow and group-specific tables and comparative analyses
Further research: Plans distinguishing efficacy populations from harm-collection populations
Remaining uncertainty: Group- and night-specific harm denominators, events, exposure and comparison CIs are unverified.
Conditions for verification: Distinguish original information on Group-specific collection populations, event and exposure denominators, and comparisons from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are short-term harm-comparison denominators, differences and CIs?
Application exceptions: 106 participants and two nights are not automatically used as valid harm denominators or declared equivalence or zero difference.
Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application

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N34 · What are harm timing and delayed or long-term findings after two nights?

Current findings: Original two-night tolerability is retained, but exact headache and event timing and delayed or long-term post-treatment observations are absent from the summary. The original states this is not material for determining long-term safety.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Harms by time and duration, and long-term and post-discontinuation material are unverified.
Reason for missing information: Harms by time and duration, and long-term and post-discontinuation material are unverified.
Required materials and conditions: Exposure and event timing and post-discontinuation follow-up
Materials to obtain first: Harm and exposure timing and subsequent follow-up
Further research: Research prespecifying delayed and long-term harms
Remaining uncertainty: Harms by time and duration, and long-term and post-discontinuation material are unverified.
Conditions for verification: Distinguish original information on Exposure and event timing and post-discontinuation follow-up from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are harm timing and delayed or long-term findings after two nights?
Application exceptions: Similar two-night tolerability is not extended into safety of repeated or long-term use.
Referenced methods: M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application

Related sources R01

N35 · What links harms to the device, sham, medical history or medications?

Current findings: The original supplies device, sham and headache context. Specific device and exposure details, alternative causes involving medical history and medications, and event attribution are absent from the summary.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Actual event-specific exposure, medical history, concurrent treatment, attribution and alternative causes are unverified.
Reason for missing information: Actual event-specific exposure, medical history, concurrent treatment, attribution and alternative causes are unverified.
Required materials and conditions: Temperature, pressure and other exposure, alternative causes and concurrent conditions
Materials to obtain first: Device logs, medical history, medications and event-assessment records
Further research: Harm plans distinguishing exposure of interest from alternative causes
Remaining uncertainty: Actual event-specific exposure, medical history, concurrent treatment, attribution and alternative causes are unverified.
Conditions for verification: Distinguish original information on Temperature, pressure and other exposure, alternative causes and concurrent conditions from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What links harms to the device, sham, medical history or medications?
Application exceptions: Pressure, skin injury, causes, prevention or care absent from the summary are not added as new clinical facts.
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

Related sources R01

N36 · Were harm-related discontinuation and missing PSG established?

Current findings: The original 106-person, two-night and tolerability descriptions do not separately describe harm-related discontinuation or collection and handling for people with missing data.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Group-specific discontinuation and missingness reasons, their relation to harms and missing-data handling are unverified.
Reason for missing information: Group-specific discontinuation and missingness reasons, their relation to harms and missing-data handling are unverified.
Required materials and conditions: Discontinuation and missingness reasons, completion of harm collection and denominators
Materials to obtain first: Discontinuation, participant flow, harm collection and missing-data material
Further research: Plans distinguishing missingness from harm-related discontinuation
Remaining uncertainty: Group-specific discontinuation and missingness reasons, their relation to harms and missing-data handling are unverified.
Conditions for verification: Distinguish original information on Discontinuation and missingness reasons, completion of harm collection and denominators from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were harm-related discontinuation and missing PSG established?
Application exceptions: Absent material is not converted into zero discontinuation, zero missingness or safety of every completer.
Referenced methods: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application

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N37 · Was independent harm evidence or separate event material obtained?

Current findings: The current preserved list concerns this two-night efficacy-trial report. Separate harm reports have not been searched or obtained here; safety statements from related claims or nights are not counted as independent reports.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Identity, populations, devices, durations and duplication of independent harm reports are unverified.
Reason for missing information: Identity, populations, devices, durations and duplication of independent harm reports are unverified.
Required materials and conditions: Independent harm reports for the same device, population and duration
Materials to obtain first: Separate harm/surveillance and event information
Further research: Independent safety research specifying population, device and exposure
Remaining uncertainty: Identity, populations, devices, durations and duplication of independent harm reports are unverified.
Conditions for verification: Distinguish original information on Independent harm reports for the same device, population and duration from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Was independent harm evidence or separate event material obtained?
Application exceptions: No separate current entry does not establish absence of every external harm report.
Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

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N38 · What is known about safety in vulnerable populations, other diseases and repeated exposure?

Current findings: Two-night material in adults with insomnia is not used to judge other diseases, populations, repeated use or long-term harms. Original safety caution and long-term limitations are retained.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Direct harm outcomes for vulnerable populations, diseases and repeated or long-term exposure are unverified.
Reason for missing information: Direct harm outcomes for vulnerable populations, diseases and repeated or long-term exposure are unverified.
Required materials and conditions: Population- and disease-specific and long-term device-safety scope
Materials to obtain first: Population-specific medical history, exposure and direct harm material
Further research: Research specifying population and repeated or long-term safety questions
Remaining uncertainty: Direct harm outcomes for vulnerable populations, diseases and repeated or long-term exposure are unverified.
Conditions for verification: Distinguish original information on Population- and disease-specific and long-term device-safety scope from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What is known about safety in vulnerable populations, other diseases and repeated exposure?
Application exceptions: No new eligibility, device-setting, cooling, sleep-care or insomnia-treatment instructions are created.
Referenced methods: M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed

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N39 · How are null PSG efficacy and safety or causal judgments separated?

Current findings: Null absolute sleep efficiency, broadly similar short-term tolerability to sham, headache reports and parent safety caution are recorded separately. Failed efficacy does not establish harm or certify harmlessness.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Comparative and causal safety and direct long-term material are unverified.
Reason for missing information: Comparative and causal safety and direct long-term material are unverified.
Required materials and conditions: Separation of sleep efficiency, harm comparisons, original caution and causality
Materials to obtain first: Harm, causality and follow-up material separate from efficacy
Further research: Plans separating different effects of interest and outcomes
Remaining uncertainty: Comparative and causal safety and direct long-term material are unverified.
Conditions for verification: Distinguish original information on Separation of sleep efficiency, harm comparisons, original caution and causality from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are null PSG efficacy and safety or causal judgments separated?
Application exceptions: Null sleep efficiency is not converted into safety benefits or harms, or treatment-replacement instructions.
Referenced methods: Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries

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N40 · How are subsequent material, condition versions, historical candidates and incomplete review linked?

Current findings: Conditions were preserved and frozen before separate application. Existing candidate review-pending and production-eligibility indicators are retained as history. Current content and claim-boundary review is incomplete, with false completion indicators, zero new units and an unrecorded final independent count.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Subsequent original material, actual reading and change events, and final user decisions on review and independence are not yet available.
Reason for missing information: Subsequent original material, actual reading and change events, and final user decisions on review and independence are not yet available.
Required materials and conditions: Identity, units and denominators, outcome hierarchy, reading and change events, and original candidates
Materials to obtain first: Additional original material, before-and-after values, versions and decision records
Further research: Research directly addressing the selected absolute sleep-efficiency gap
Remaining uncertainty: Subsequent original material, actual reading and change events, and final user decisions on review and independence are not yet available.
Conditions for verification: Distinguish original information on Identity, units and denominators, outcome hierarchy, reading and change events, and original candidates from unverified details and extensions to other sleep outcomes, harms and long-term findings.
Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are subsequent material, condition versions, historical candidates and incomplete review linked?
Application exceptions: Historical full-text cross-checking or completed production is not invented as current model or clinical content review or completed publication.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

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