{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2982-s1", "verdict_number": "2982", "title": "Forehead-cooling device × Absolute sleep efficiency: The original null result and remaining evidence gaps", "view_version": "1.0", "view_created_date": "2026-10-15", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "106 adults with insomnia, two nights", "intervention": "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", "endpoint": "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", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "How is the selected sleep-efficiency claim distinguished from the related latency claim?", "needed": "Sleep-efficiency question and verdict record versus parent and latency context", "role": "Required", "role_reason": "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_exception": "Related claims and co-primary context do not add new units to the selected question.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "A prespecified plan distinguishing sleep-efficiency and latency effects of interest", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Clinical independence was not newly certified.", "uncertainty": "Clinical independence was not newly certified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original question, device, population, comparator and endpoint, and scope-change records" }, { "item_id": "N02", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What are the subclaim grade, note and absent values?", "needed": "Subclaim D and note, absent score, status and axes, and parent history", "role": "Required", "role_reason": "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_exception": "Parent 28 points and axes such as C0 are not transferred into subclaim scores or axes, or a passed current review.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Records separating existing grades and values from updates with additional evidence", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. The original subclaim lacks a score, status and axes.", "missingness": "Subclaim score/status/axes are absent in the original.", "uncertainty": "Subclaim score/status/axes are absent in the original.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original subclaim and an explicit change event" }, { "item_id": "N03", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Which people with insomnia were studied?", "needed": "Diagnosed adults with insomnia and recruitment and baseline scope", "role": "Required", "role_reason": "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_exception": "Efficacy is not newly extended to other sleep disorders, vulnerable populations or the general population.", "criterion": "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.", "basis": "M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying the population with insomnia", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact diagnostic criteria, duration, severity, inclusion and exclusion criteria, and demographic characteristics are unverified.", "uncertainty": "Exact diagnostic criteria, duration, severity, inclusion and exclusion criteria, and demographic characteristics are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Diagnostic and eligibility records and baseline tables" }, { "item_id": "N04", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Were comorbidities, medications and baseline sleep established?", "needed": "Baseline insomnia, medication and concurrent treatment, and assessment criteria", "role": "Required", "role_reason": "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_exception": "Use, discontinuation or replacement of sleep medication or other treatments is not added to the original study.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying shared conditions and concurrent treatment", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original summary does not separately present baseline sleep efficiency or latency, medications, comorbidities, or selection and control of other treatments.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Baseline sleep, medical history and medications, concurrent treatment and between-group differences are unverified.", "uncertainty": "Baseline sleep, medical history and medications, concurrent treatment and between-group differences are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline assessments, medication and treatment, and eligibility records" }, { "item_id": "N05", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What distinguishes the active device from an ordinary cold pack?", "needed": "Device type, active temperature and study exposure", "role": "Required", "role_reason": "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_exception": "14-16°C is not converted into instructions for device settings, forehead cooling or cold packs.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying the device and active exposure", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Device model and components, wearing and operating duration, temperature measurement and actual adherence are unverified.", "uncertainty": "Device model and components, wearing and operating duration, temperature measurement and actual adherence are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Device specifications and actual study exposure and adherence" }, { "item_id": "N06", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What were the sham-device control conditions?", "needed": "Sham design, exposure and comparison, and feasibility of blinding", "role": "Required", "role_reason": "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_exception": "Sham is not substituted with no treatment, a specified temperature, or a direct comparison with sleep medication.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying the sham intervention and comparison of interest", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original records a randomized comparison of active cooling and a sham device. Sham temperature, sensation, appearance, operation and blinding details are not presented.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Sham specifications, actual adherence, recognition of conditions and shared procedures are unverified.", "uncertainty": "Sham specifications, actual adherence, recognition of conditions and shared procedures are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Active and sham specifications and condition-recognition and procedure material" }, { "item_id": "N07", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "How are two-night exposure and measurement separated from lasting effects?", "needed": "Actual measurement nights, exposure duration, and baseline and follow-up schedules", "role": "Required", "role_reason": "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_exception": "Two nights are not counted as separate independent trials or additional participants, or extended into ongoing-use effects.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research distinguishing baseline, measurement nights and follow-up in advance", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Each night's and baseline assessment schedules, analytical aggregation and long-term outcomes are unverified.", "uncertainty": "Each night's and baseline assessment schedules, analytical aggregation and long-term outcomes are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Measurement and exposure schedules and night-specific result tables" }, { "item_id": "N08", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "How is absolute sleep efficiency defined and measured by PSG?", "needed": "Sleep-efficiency definition, measurement and calculation units, and assessment procedures", "role": "Required", "role_reason": "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_exception": "Percentage points are not converted into relative percentages, minutes asleep or individual efficacy.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research with explicit sleep-efficiency and measurement plans", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Sleep-efficiency formulas and denominators, measurement, scoring and eligibility criteria are unverified.", "uncertainty": "Sleep-efficiency formulas and denominators, measurement, scoring and eligibility criteria are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "PSG methods, sleep-efficiency definitions and result tables" }, { "item_id": "N09", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What are the original sleep-efficiency between-group difference, CI and P value?", "needed": "Original comparison of +0.5 percentage points, 95% CI -3.4 to 4.5, P=.759", "role": "Required", "role_reason": "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_exception": "The original null result is not newly judged as an exactly zero effect, equivalence or nonresponse in every person.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research prespecifying effects of interest, intervals and measurement nights", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Detailed models, adjustment, denominators and aggregation of measurement nights for the contrast direction are unverified.", "uncertainty": "Detailed models, adjustment, denominators and aggregation of measurement nights for the contrast direction are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis models and absolute sleep-efficiency result and denominator tables" }, { "item_id": "N10", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Were group-specific absolute, baseline and final values and changes established?", "needed": "Group-specific sleep efficiency, baseline, final values and changes, and adjustment", "role": "Required", "role_reason": "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_exception": "The between-group +0.5 percentage points is not copied as each group's change or an individual's increase.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Plans distinguishing absolute values and changes, and within-group and between-group comparisons", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Group- and night-specific absolute values, baseline values and changes, variance, CIs and adjustment are unverified.", "uncertainty": "Group- and night-specific absolute values, baseline values and changes, variance, CIs and adjustment are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline, each night's and group-specific findings and analysis tables" }, { "item_id": "N11", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "How are the original CI and null statement separated from importance?", "needed": "Precision, importance, the original null result and clinical interpretation", "role": "Required", "role_reason": "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_exception": "A P value alone does not create new precision certification or equivalence or safety judgments.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research prespecifying intervals, importance and effects of interest", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Importance criteria, prespecified power and equivalence margins, and model details are unverified.", "uncertainty": "Importance criteria, prespecified power and equivalence margins, and model details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Effect, importance and testing plans, and original findings" }, { "item_id": "N12", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What is the context of the related absolute-latency claim?", "needed": "Different units and effects for latency and selected sleep efficiency", "role": "Supplementary", "role_reason": "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_exception": "Related findings and the same report are not added as new independent trials or participants.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Plans distinguishing latency and sleep efficiency", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Latency definitions, individual and night-specific values, and model details are unverified.", "uncertainty": "Latency definitions, individual and night-specific values, and model details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate definitions, denominators and result tables for each endpoint" }, { "item_id": "N13", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What are the relative-latency and sleep-stage supportive findings?", "needed": "Relative persistent-sleep latency and entry to stages 1 and 2 versus the selected finding", "role": "Supplementary", "role_reason": "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_exception": "Positive supportive latency findings are not converted into success of the absolute sleep-efficiency co-primary endpoint or efficacy of replacing treatment.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Confirmatory research separating primary, secondary and exploratory findings", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact definitions, effects, CIs, prespecified or exploratory plans, and denominators for supportive findings are unverified.", "uncertainty": "Exact definitions, effects, CIs, prespecified or exploratory plans, and denominators for supportive findings are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Supportive-result tables and protocol and SAP hierarchy" }, { "item_id": "N14", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Were other sleep outcomes, symptoms and quality of life established?", "needed": "Objective selected endpoints versus subjective and everyday outcomes", "role": "Supplementary", "role_reason": "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_exception": "PSG or supportive findings are not promoted into established overall sleep or insomnia-treatment success.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Plans distinguishing PSG, symptoms and function", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Those outcome definitions, effects, CIs, denominators and duration are unverified.", "uncertainty": "Those outcome definitions, effects, CIs, denominators and duration are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Subjective and patient-important outcomes and analysis tables" }, { "item_id": "N15", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Are original prespecified co-primary statements separated from reading external plans?", "needed": "Original co-primary hierarchy for absolute persistent-sleep latency and absolute sleep efficiency", "role": "Required", "role_reason": "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_exception": "Unread external material does not erase the original prespecification statement or create current prespecification certification.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying co-primary outcomes and success criteria", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual hierarchy, dates and success rules in registration versions, protocols and SAPs have not been read.", "uncertainty": "Actual hierarchy, dates and success rules in registration versions, protocols and SAPs have not been read.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration, protocol and SAP versions and outcome plans" }, { "item_id": "N16", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What separates the registration identifier from actual registration and plan content?", "needed": "Original NCT01966211 identifier versus versions, dates and reading", "role": "Required", "role_reason": "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_exception": "The original identifier and historical Codex full-text cross-check are not promoted into current reading or verification of registration content.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Records linking plan amendments and published findings", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "NCT01966211 in the evidence and citation is linked in its original form. External registration, protocol and SAP have not been newly retrieved or read.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual registration content, amendments, versions, dates and plans are unverified.", "uncertainty": "Actual registration content, amendments, versions, dates and plans are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration versions, protocol and SAP" }, { "item_id": "N17", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Were supportive and exploratory findings, multiplicity and selective reporting addressed?", "needed": "Positive supportive findings after primary failure, multiplicity and prespecified analyses", "role": "Required", "role_reason": "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_exception": "Positive supportive findings alone do not replace the selected sleep-efficiency failure or create a new effect judgment.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research fixing the hierarchy of primary, secondary and exploratory outcomes", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Supportive versus exploratory classification, testing lists, multiplicity and selective-reporting plans are unverified.", "uncertainty": "Supportive versus exploratory classification, testing lists, multiplicity and selective-reporting plans are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocol, SAP and complete result lists" }, { "item_id": "N18", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Were randomization, allocation concealment and blinding established?", "needed": "Actual procedures for the prospective randomized sham comparison", "role": "Required", "role_reason": "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_exception": "The name sham-controlled does not certify successful blinding or absence of bias.", "criterion": "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.", "basis": "M08 §8.1–8.2.3; own application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Blinding and allocation plans for device-versus-sham comparisons", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Sequence generation, concealment, blinding, recognition of conditions and baseline balance are unverified.", "uncertainty": "Sequence generation, concealment, blinding, recognition of conditions and baseline balance are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation and blinding material, baseline tables and protocol" }, { "item_id": "N19", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What are total 106 and group- and outcome-specific allocation and denominators?", "needed": "Overall allocation versus completion, analysis, and night- and endpoint-specific denominators", "role": "Required", "role_reason": "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_exception": "106 participants are not divided into invented group allocations, and two-night observations are not added as new participants.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Plans distinguishing allocation, people, nights and analysis populations", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Group-specific flow, completion and analysis, and valid night and endpoint denominators are unverified.", "uncertainty": "Group-specific flow, completion and analysis, and valid night and endpoint denominators are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow and night- and outcome-specific analysis tables" }, { "item_id": "N20", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What are the analysis units for nights, baseline and repeated measurements, and people?", "needed": "Nights and visits in the same participants, effects of interest and correlation", "role": "Required", "role_reason": "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_exception": "Two-night findings are not duplicated to increase replication counts or sample size.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying repeated observations and participant-level effects of interest", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Night-specific data, repeated-measures and aggregation methods, and baseline and period models are unverified.", "uncertainty": "Night-specific data, repeated-measures and aggregation methods, and baseline and period models are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Night-specific and baseline data and analysis plans" }, { "item_id": "N21", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "How are withdrawal, incomplete assessments, ineligible PSG and missing data handled?", "needed": "Missing participants and nights, reasons for missingness and discontinuation, and handling", "role": "Required", "role_reason": "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_exception": "Absent material is not declared zero withdrawal, complete two-night participation, ITT or PP.", "criterion": "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.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research prespecifying missingness and effects of interest", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original 106-person, two-night summary does not separately present group-specific withdrawal, incomplete or ineligible PSG, missing endpoints or handling methods.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Reasons for missingness and discontinuation, denominators, imputation, sensitivity analyses and analysis populations are unverified.", "uncertainty": "Reasons for missingness and discontinuation, denominators, imputation, sensitivity analyses and analysis populations are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "PSG eligibility, participant flow, missing-data handling and SAP" }, { "item_id": "N22", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Are within-group, between-group, adjusted, absolute and change effects distinguished?", "needed": "Original between-group contrast versus each group's changes, adjustment and models", "role": "Required", "role_reason": "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_exception": "+0.5 percentage points and -7.9 minutes are not transferred into other effects or denominators or newly analyzed.", "criterion": "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.", "basis": "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.", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research separating absolute values, changes, relative measures, within-group and between-group contrasts", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Models, adjustment, baseline values, changes, within-group and between-group contrasts, and supportive definitions are unverified.", "uncertainty": "Models, adjustment, baseline values, changes, within-group and between-group contrasts, and supportive definitions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Definitions, denominators, models and SAP for each effect of interest" }, { "item_id": "N23", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What are actual device exposure, adherence, deviations and concurrent treatment?", "needed": "Actual device operation, wearing, discontinuation and shared conditions", "role": "Required", "role_reason": "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_exception": "Original device exposure is not turned into implementation or sleep and insomnia treatment-replacement instructions.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research distinguishing actual exposure from assignment effects of interest", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Adherence, deviations, shared care, and medication and treatment changes are unverified.", "uncertainty": "Adherence, deviations, shared care, and medication and treatment changes are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Device logs, exposure, shared treatment and deviation records" }, { "item_id": "N24", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What original information describes developer and public support and author interests?", "needed": "NIH/NHLBI and Ebb Therapeutics support and author roles", "role": "Required", "role_reason": "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_exception": "Original historical I0 and B2 are not inherited as new review findings, and support information alone does not change judgments on the figures.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Explicit reporting of support and design and analysis roles", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Financial and in-kind support, design, analysis and data-access roles, and detailed disclosures are unverified.", "uncertainty": "Financial and in-kind support, design, analysis and data-access roles, and detailed disclosures are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Support, author-interest and role disclosures" }, { "item_id": "N25", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "How are reports, trials, related claims, nights and groups linked within the same family?", "needed": "The single Roth2018 reference and trial versus duplicate observations", "role": "Required", "role_reason": "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_exception": "One report entry is not certification of a final count of clinical independence.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Records distinguishing reports from study families", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Some original summary information was linked for production; clinical verification/review is incomplete. Related report/trial relationships and unique trial/participant totals are unverified.", "missingness": "Related report/trial relationships and unique trial/participant totals are unverified.", "uncertainty": "Related report/trial relationships and unique trial/participant totals are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial and report identity, related reports and observation units" }, { "item_id": "N26", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What independent confirmation or replication supports selected sleep efficiency?", "needed": "Direct independent research on the same absolute sleep-efficiency question", "role": "Required", "role_reason": "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_exception": "An original single-trial statement is not converted into verification of no current research worldwide, and related sheets are not counted as independent replication.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Separate confirmatory research addressing the same question", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Populations, devices, endpoints, duplication and independence of separate direct reports are unverified.", "uncertainty": "Populations, devices, endpoints, duplication and independence of separate direct reports are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct confirmatory reports and trial identity" }, { "item_id": "N27", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Can findings apply to other devices, populations, durations or subgroups?", "needed": "Extrapolation beyond the original device and population to general cooling and subgroups", "role": "Supplementary", "role_reason": "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_exception": "No new claims of null effects for every cooling method, specific-population benefits, or device recommendations and use instructions are created.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying direct applicability", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct population, device, subgroup and long-term findings and interactions are unverified.", "uncertainty": "Direct population, device, subgroup and long-term findings and interactions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct population- and device-specific material and prespecified subgroup plans" }, { "item_id": "N28", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Are PSG findings distinguished from long-term and patient-important insomnia effects?", "needed": "Two-night objective measures versus symptoms, everyday function and persistence", "role": "Supplementary", "role_reason": "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_exception": "Positive supportive latency findings are not extended into drug-like efficacy, replacement of treatment or long-term success.", "criterion": "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.", "basis": "M03 §3.2.4; internally defined extension boundaries; M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are internally designed", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research separating PSG from long-term clinical questions", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct persistence, post-discontinuation, patient-important and treatment-replacement outcomes are unverified.", "uncertainty": "Direct persistence, post-discontinuation, patient-important and treatment-replacement outcomes are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term and patient-important outcomes and follow-up" }, { "item_id": "N29", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What has actually been obtained and read, and what do URLs and registration links mean?", "needed": "Local stored summary versus external abstract, full text and plans", "role": "Required", "role_reason": "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_exception": "Presence of a URL, PMCID or NCT identifier is not presented as external acquisition, reading or a successful link check.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Records separating summary preservation from new acquisition and reading", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Current verification of detailed external original methods, findings, registration and plans is incomplete.", "uncertainty": "Current verification of detailed external original methods, findings, registration and plans is incomplete.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Obtained original material and actual reading and update events" }, { "item_id": "N30", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "How are Korean and English texts, dates, corrections, empty values and historical axes preserved?", "needed": "Original language texts, dates, corrections, axes and verification statements", "role": "Required", "role_reason": "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_exception": "Historical Codex full-text cross-checking is not inherited as passed current clinical review or external reading.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Separation of original-value preservation from new evidence and changes", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Detailed external translation and comparisons with original texts, corrections and registration were not performed here.", "uncertainty": "Detailed external translation and comparisons with original texts, corrections and registration were not performed here.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original texts, language-specific changes, dates and correction events" }, { "item_id": "N31", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Were adverse-event collection, definitions and scope established?", "needed": "Active and passive collection, event definitions, severity and discontinuation", "role": "Supplementary", "role_reason": "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_exception": "A statement of similar patterns is not converted into zero harms, equivalent safety or absence of every risk.", "criterion": "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.", "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying harm collection separately from efficacy", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Collection, definitions, severity, complete harm events and discontinuation tables are unverified.", "uncertainty": "Collection, definitions, severity, complete harm events and discontinuation tables are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm-collection plans and complete event and discontinuation tables" }, { "item_id": "N32", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Which group, event and denominator does the headache report refer to?", "needed": "Headache groups, people, events, attribution and denominators", "role": "Supplementary", "role_reason": "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_exception": "Headache is not transferred into a confirmed active-group event, and absent counts or incidence rates are not invented.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Harm research with explicit event, person and exposure units", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Group-specific headache counts, valid denominators, severity, causality and timing are unverified.", "uncertainty": "Group-specific headache counts, valid denominators, severity, causality and timing are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Headache and other event tables, collection denominators and attribution records" }, { "item_id": "N33", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What are short-term harm-comparison denominators, differences and CIs?", "needed": "Group-specific collection populations, event and exposure denominators, and comparisons", "role": "Supplementary", "role_reason": "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_exception": "106 participants and two nights are not automatically used as valid harm denominators or declared equivalence or zero difference.", "criterion": "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.", "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Plans distinguishing efficacy populations from harm-collection populations", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original records broadly similar acute tolerability to sham. Group-specific harm-collection and event denominators, effects, CIs and equivalence tests are not presented.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Group- and night-specific harm denominators, events, exposure and comparison CIs are unverified.", "uncertainty": "Group- and night-specific harm denominators, events, exposure and comparison CIs are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm-flow and group-specific tables and comparative analyses" }, { "item_id": "N34", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What are harm timing and delayed or long-term findings after two nights?", "needed": "Exposure and event timing and post-discontinuation follow-up", "role": "Supplementary", "role_reason": "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_exception": "Similar two-night tolerability is not extended into safety of repeated or long-term use.", "criterion": "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.", "basis": "M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research prespecifying delayed and long-term harms", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Harms by time and duration, and long-term and post-discontinuation material are unverified.", "uncertainty": "Harms by time and duration, and long-term and post-discontinuation material are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm and exposure timing and subsequent follow-up" }, { "item_id": "N35", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What links harms to the device, sham, medical history or medications?", "needed": "Temperature, pressure and other exposure, alternative causes and concurrent conditions", "role": "Supplementary", "role_reason": "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_exception": "Pressure, skin injury, causes, prevention or care absent from the summary are not added as new clinical facts.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Harm plans distinguishing exposure of interest from alternative causes", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Actual event-specific exposure, medical history, concurrent treatment, attribution and alternative causes are unverified.", "uncertainty": "Actual event-specific exposure, medical history, concurrent treatment, attribution and alternative causes are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Device logs, medical history, medications and event-assessment records" }, { "item_id": "N36", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Were harm-related discontinuation and missing PSG established?", "needed": "Discontinuation and missingness reasons, completion of harm collection and denominators", "role": "Supplementary", "role_reason": "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_exception": "Absent material is not converted into zero discontinuation, zero missingness or safety of every completer.", "criterion": "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.", "basis": "M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Plans distinguishing missingness from harm-related discontinuation", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Group-specific discontinuation and missingness reasons, their relation to harms and missing-data handling are unverified.", "uncertainty": "Group-specific discontinuation and missingness reasons, their relation to harms and missing-data handling are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Discontinuation, participant flow, harm collection and missing-data material" }, { "item_id": "N37", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "Was independent harm evidence or separate event material obtained?", "needed": "Independent harm reports for the same device, population and duration", "role": "Supplementary", "role_reason": "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_exception": "No separate current entry does not establish absence of every external harm report.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Independent safety research specifying population, device and exposure", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Identity, populations, devices, durations and duplication of independent harm reports are unverified.", "uncertainty": "Identity, populations, devices, durations and duplication of independent harm reports are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate harm/surveillance and event information" }, { "item_id": "N38", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "What is known about safety in vulnerable populations, other diseases and repeated exposure?", "needed": "Population- and disease-specific and long-term device-safety scope", "role": "Supplementary", "role_reason": "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_exception": "No new eligibility, device-setting, cooling, sleep-care or insomnia-treatment instructions are created.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research specifying population and repeated or long-term safety questions", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Direct harm outcomes for vulnerable populations, diseases and repeated or long-term exposure are unverified.", "uncertainty": "Direct harm outcomes for vulnerable populations, diseases and repeated or long-term exposure are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Population-specific medical history, exposure and direct harm material" }, { "item_id": "N39", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "How are null PSG efficacy and safety or causal judgments separated?", "needed": "Separation of sleep efficiency, harm comparisons, original caution and causality", "role": "Supplementary", "role_reason": "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_exception": "Null sleep efficiency is not converted into safety benefits or harms, or treatment-replacement instructions.", "criterion": "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.", "basis": "Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Plans separating different effects of interest and outcomes", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Comparative and causal safety and direct long-term material are unverified.", "uncertainty": "Comparative and causal safety and direct long-term material are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm, causality and follow-up material separate from efficacy" }, { "item_id": "N40", "question_type": "Absolute sleep efficiency and evidence gaps", "question": "How are subsequent material, condition versions, historical candidates and incomplete review linked?", "needed": "Identity, units and denominators, outcome hierarchy, reading and change events, and original candidates", "role": "Supplementary", "role_reason": "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_exception": "Historical full-text cross-checking or completed production is not invented as current model or clinical content review or completed publication.", "criterion": "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.", "basis": "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", "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete", "proposed_research": "Research directly addressing the selected absolute sleep-efficiency gap", "current_reports": [ "R01" ], "existence": "A stored device-trial summary exists; external details and follow-up are unread and require material", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Subsequent original material, actual reading and change events, and final user decisions on review and independence are not yet available.", "uncertainty": "Subsequent original material, actual reading and change events, and final user decisions on review and independence are not yet available.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional original material, before-and-after values, versions and decision records" } ], "reports": [ { "report_id": "R01", "title": "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.", "url": "https://pubmed.ncbi.nlm.nih.gov/29648642/", "report_type": "Stored report of Roth2018 two-night active-versus-sham device PSG findings", "existence": "Reference and stored summary exist; external original texts, registration and details unread", "acquired_read": "Summary read; external materials unread, access not attempted", "study_family": "SF01", "independent_replication": "The same people, groups, nights, visits, co-primary and supportive findings, and related sheets are not added as new independent trials or participants.", "observed_result": "-7.9 minutes (95% CI -18.4 to 2.6), P=.092; +0.5 percentage points (-3.4 to 4.5), P=.759", "result_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.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved summary", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Only acquisition and reading of the complete parent summary are meant; original paper and registration have not been obtained." }, { "material_type": "Abstract", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the original citation link is connected. External access, content verification and link tests have not been attempted." }, { "material_type": "Full paper", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original PMCID reference is retained; full-text content has not been newly obtained or read." }, { "material_type": "Registration material", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original NCT01966211 identifier retained. Registration versions and content unread; access not attempted." }, { "material_type": "Protocol", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original active and sham, PSG and night, co-primary and supportive, and harm plans are needed. Public availability and existence are unverified." }, { "material_type": "Statistical analysis plan", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original plans for absolute values, changes, between-group and within-group contrasts, repeated nights, missingness, hierarchy and multiplicity are needed." }, { "material_type": "Result tables and PSG, denominator and harm records", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Group, night and endpoint denominators, absolute and baseline values and changes, supportive findings, headache and other harm details are needed. No new calculations." }, { "material_type": "Funding/conflict-of-interest disclosures", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original disclosures on NIH/NHLBI, developer device and study involvement, and author roles are currently unread." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/29648642/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." } ], "status_dictionary": { "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-15", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public page and data were prepared from the existing 40 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-15" }