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

Verdict 2982 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-09-07  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-15

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: 106 adults with insomnia, two nights
- Ingredient, formulation and route: A forehead temperature-regulating device delivering frontal thermal therapy at 14-16°C
- Dose: Original active frontal thermal exposure at 14-16°C; not device-setting, cooling or sleep-care instructions
- Comparator: Original sham device; detailed operation, temperature, blinding and shared conditions unverified
- Measured outcome: Original between-group difference in the absolute sleep-efficiency co-primary PSG endpoint, in percentage points; separate from related latency and supportive findings
- Duration: Two nights
- Questions outside this scope: Replacing a null absolute sleep-efficiency co-primary result with positive supportive latency findings; Converting a between-group percentage-point difference into group or individual changes, relative percentages or time; Adding related sheets, groups, nights, visits or the same report as independent trials or participants; Extending two-night tolerability or PSG findings into long-term efficacy, safety or overall treatment success; Device, forehead-cooling, sleep, insomnia or treatment-replacement implementation instructions

## Checklist items

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The selected existing question is improved absolute sleep efficiency. Its subclaim record is linked while improved absolute latency to persistent sleep and parent context are retained. These are not counted as new questions, subdivisions or trials.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Clinical independence has not been newly certified.
- Reason for missing information: Clinical independence was not newly certified.
- Required materials and conditions: Sleep-efficiency question and verdict record versus parent and latency context
- Materials to obtain first: Original question, device, population, comparator and endpoint, and scope-change records
- Further research: A prespecified plan distinguishing sleep-efficiency and latency effects of interest
- Conditions for verification: Distinguish original information on Sleep-efficiency question and verdict record versus parent and latency context from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How is the selected sleep-efficiency claim distinguished from the related latency claim?
- Application exceptions: Related claims and co-primary context do not add new units to the selected question.
- Remaining uncertainty: Clinical independence was not newly certified.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The selected grade D and original note that P=.759 was null are retained. Subclaim score, status and axes fields are absent; parent D with 28 points and axes are separate historical values.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. The original subclaim lacks a score, status and axes.
- Reason for missing information: Subclaim score/status/axes are absent in the original.
- Required materials and conditions: Subclaim D and note, absent score, status and axes, and parent history
- Materials to obtain first: Original subclaim and an explicit change event
- Further research: Records separating existing grades and values from updates with additional evidence
- Conditions for verification: Distinguish original information on Subclaim D and note, absent score, status and axes, and parent history from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the subclaim grade, note and absent values?
- Application exceptions: Parent 28 points and axes such as C0 are not transferred into subclaim scores or axes, or a passed current review.
- Remaining uncertainty: Subclaim score/status/axes are absent in the original.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
- Related sources: R01

### N03 · Which people with insomnia were studied?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original research description records randomization of 106 adults with diagnosed insomnia to active or sham devices. This is not direct material for every sleep problem or other disease population.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Exact diagnostic criteria, duration, severity, inclusion and exclusion criteria, and demographic characteristics are unverified.
- Reason for missing information: Exact diagnostic criteria, duration, severity, inclusion and exclusion criteria, and demographic characteristics are unverified.
- Required materials and conditions: Diagnosed adults with insomnia and recruitment and baseline scope
- Materials to obtain first: Diagnostic and eligibility records and baseline tables
- Further research: Research specifying the population with insomnia
- Conditions for verification: Distinguish original information on Diagnosed adults with insomnia and recruitment and baseline scope from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Which people with insomnia were studied?
- Application exceptions: Efficacy is not newly extended to other sleep disorders, vulnerable populations or the general population.
- Remaining uncertainty: Exact diagnostic criteria, duration, severity, inclusion and exclusion criteria, and demographic characteristics are unverified.
- Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application
- Related sources: R01

### N04 · Were comorbidities, medications and baseline sleep established?

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original summary does not separately present baseline sleep efficiency or latency, medications, comorbidities, or selection and control of other treatments.
- Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Baseline sleep, medical history and medications, concurrent treatment and between-group differences are unverified.
- Reason for missing information: Baseline sleep, medical history and medications, concurrent treatment and between-group differences are unverified.
- Required materials and conditions: Baseline insomnia, medication and concurrent treatment, and assessment criteria
- Materials to obtain first: Baseline assessments, medication and treatment, and eligibility records
- Further research: Research specifying shared conditions and concurrent treatment
- Conditions for verification: Distinguish original information on Baseline insomnia, medication and concurrent treatment, and assessment criteria from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were comorbidities, medications and baseline sleep established?
- Application exceptions: Use, discontinuation or replacement of sleep medication or other treatments is not added to the original study.
- Remaining uncertainty: Baseline sleep, medical history and medications, concurrent treatment and between-group differences are unverified.
- Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original device delivered frontal thermal therapy regulating forehead temperature at 14-16°C. The existing study-conditions description records that it is not the same intervention as an ordinary cold pack.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Device model and components, wearing and operating duration, temperature measurement and actual adherence are unverified.
- Reason for missing information: Device model and components, wearing and operating duration, temperature measurement and actual adherence are unverified.
- Required materials and conditions: Device type, active temperature and study exposure
- Materials to obtain first: Device specifications and actual study exposure and adherence
- Further research: Research specifying the device and active exposure
- Conditions for verification: Distinguish original information on Device type, active temperature and study exposure from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What distinguishes the active device from an ordinary cold pack?
- Application exceptions: 14-16°C is not converted into instructions for device settings, forehead cooling or cold packs.
- Remaining uncertainty: Device model and components, wearing and operating duration, temperature measurement and actual adherence are unverified.
- Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed
- Related sources: R01

### N06 · What were the sham-device control conditions?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original records a randomized comparison of active cooling and a sham device. Sham temperature, sensation, appearance, operation and blinding details are not presented.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Sham specifications, actual adherence, recognition of conditions and shared procedures are unverified.
- Reason for missing information: Sham specifications, actual adherence, recognition of conditions and shared procedures are unverified.
- Required materials and conditions: Sham design, exposure and comparison, and feasibility of blinding
- Materials to obtain first: Active and sham specifications and condition-recognition and procedure material
- Further research: Research specifying the sham intervention and comparison of interest
- Conditions for verification: Distinguish original information on Sham design, exposure and comparison, and feasibility of blinding from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What were the sham-device control conditions?
- Application exceptions: Sham is not substituted with no treatment, a specified temperature, or a direct comparison with sleep medication.
- Remaining uncertainty: Sham specifications, actual adherence, recognition of conditions and shared procedures are unverified.
- Referenced methods: M03 §3.2.2–3.2.3; reverse-direction markers and assessment adaptation are internally designed; M08 §8.1–8.2.3; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original records 106 participants and two nights of assessment and efficacy follow-up. Night-specific values, order, baseline or adaptation nights, and long-term or post-treatment follow-up details are absent from the summary.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Each night's and baseline assessment schedules, analytical aggregation and long-term outcomes are unverified.
- Reason for missing information: Each night's and baseline assessment schedules, analytical aggregation and long-term outcomes are unverified.
- Required materials and conditions: Actual measurement nights, exposure duration, and baseline and follow-up schedules
- Materials to obtain first: Measurement and exposure schedules and night-specific result tables
- Further research: Research distinguishing baseline, measurement nights and follow-up in advance
- Conditions for verification: Distinguish original information on Actual measurement nights, exposure duration, and baseline and follow-up schedules from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are two-night exposure and measurement separated from lasting effects?
- Application exceptions: Two nights are not counted as separate independent trials or additional participants, or extended into ongoing-use effects.
- Remaining uncertainty: Each night's and baseline assessment schedules, analytical aggregation and long-term outcomes are unverified.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original selected outcome is absolute sleep efficiency, described as one co-primary PSG endpoint. Its between-group result uses percentage points. Detailed formulas, PSG scoring and criteria are not presented.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Sleep-efficiency formulas and denominators, measurement, scoring and eligibility criteria are unverified.
- Reason for missing information: Sleep-efficiency formulas and denominators, measurement, scoring and eligibility criteria are unverified.
- Required materials and conditions: Sleep-efficiency definition, measurement and calculation units, and assessment procedures
- Materials to obtain first: PSG methods, sleep-efficiency definitions and result tables
- Further research: Research with explicit sleep-efficiency and measurement plans
- Conditions for verification: Distinguish original information on Sleep-efficiency definition, measurement and calculation units, and assessment procedures from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How is absolute sleep efficiency defined and measured by PSG?
- Application exceptions: Percentage points are not converted into relative percentages, minutes asleep or individual efficacy.
- Remaining uncertainty: Sleep-efficiency formulas and denominators, measurement, scoring and eligibility criteria are unverified.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original reader answer records an absolute sleep-efficiency between-group difference of +0.5 percentage points (95% CI -3.4 to 4.5), P=.759. The null statement in the selected subclaim note is retained; no new effect or CI is calculated.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Detailed models, adjustment, denominators and aggregation of measurement nights for the contrast direction are unverified.
- Reason for missing information: Detailed models, adjustment, denominators and aggregation of measurement nights for the contrast direction are unverified.
- Required materials and conditions: Original comparison of +0.5 percentage points, 95% CI -3.4 to 4.5, P=.759
- Materials to obtain first: Analysis models and absolute sleep-efficiency result and denominator tables
- Further research: Research prespecifying effects of interest, intervals and measurement nights
- Conditions for verification: Distinguish original information on Original comparison of +0.5 percentage points, 95% CI -3.4 to 4.5, P=.759 from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the original sleep-efficiency between-group difference, CI and P value?
- Application exceptions: The original null result is not newly judged as an exactly zero effect, equivalence or nonresponse in every person.
- Remaining uncertainty: Detailed models, adjustment, denominators and aggregation of measurement nights for the contrast direction are unverified.
- Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application
- Related sources: R01

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

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The current summary provides the absolute sleep-efficiency between-group difference, but does not separately provide each group's absolute values, baseline values, changes from baseline or night-specific values.
- Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Group- and night-specific absolute values, baseline values and changes, variance, CIs and adjustment are unverified.
- Reason for missing information: Group- and night-specific absolute values, baseline values and changes, variance, CIs and adjustment are unverified.
- Required materials and conditions: Group-specific sleep efficiency, baseline, final values and changes, and adjustment
- Materials to obtain first: Baseline, each night's and group-specific findings and analysis tables
- Further research: Plans distinguishing absolute values and changes, and within-group and between-group comparisons
- Conditions for verification: Distinguish original information on Group-specific sleep efficiency, baseline, final values and changes, and adjustment from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were group-specific absolute, baseline and final values and changes established?
- Application exceptions: The between-group +0.5 percentage points is not copied as each group's change or an individual's increase.
- Remaining uncertainty: Group- and night-specific absolute values, baseline values and changes, variance, CIs and adjustment are unverified.
- Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: Original CIs and P values are retained. Parent precision C0 and effect E0 are historical axes. Clinical importance, equivalence margins and individual responses have not been separately established.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Importance criteria, prespecified power and equivalence margins, and model details are unverified.
- Reason for missing information: Importance criteria, prespecified power and equivalence margins, and model details are unverified.
- Required materials and conditions: Precision, importance, the original null result and clinical interpretation
- Materials to obtain first: Effect, importance and testing plans, and original findings
- Further research: Research prespecifying intervals, importance and effects of interest
- Conditions for verification: Distinguish original information on Precision, importance, the original null result and clinical interpretation from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are the original CI and null statement separated from importance?
- Application exceptions: A P value alone does not create new precision certification or equivalence or safety judgments.
- Remaining uncertainty: Importance criteria, prespecified power and equivalence margins, and model details are unverified.
- Referenced methods: M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The latency sheet has grade D and a null P=.092; the original parent between-group difference is -7.9 minutes (95% CI -18.4 to 2.6), P=.092. This remains a latency result and is not transferred into selected sleep efficiency in percentage points.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Latency definitions, individual and night-specific values, and model details are unverified.
- Reason for missing information: Latency definitions, individual and night-specific values, and model details are unverified.
- Required materials and conditions: Different units and effects for latency and selected sleep efficiency
- Materials to obtain first: Separate definitions, denominators and result tables for each endpoint
- Further research: Plans distinguishing latency and sleep efficiency
- Conditions for verification: Distinguish original information on Different units and effects for latency and selected sleep efficiency from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What is the context of the related absolute-latency claim?
- Application exceptions: Related findings and the same report are not added as new independent trials or participants.
- Remaining uncertainty: Latency definitions, individual and night-specific values, and model details are unverified.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internal extension boundaries
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original states that relative latency to persistent sleep and some latencies to stages 1 and 2 favored treatment in supportive analyses. Exact values, CIs, denominators and analysis hierarchy are absent from the summary.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Exact definitions, effects, CIs, prespecified or exploratory plans, and denominators for supportive findings are unverified.
- Reason for missing information: Exact definitions, effects, CIs, prespecified or exploratory plans, and denominators for supportive findings are unverified.
- Required materials and conditions: Relative persistent-sleep latency and entry to stages 1 and 2 versus the selected finding
- Materials to obtain first: Supportive-result tables and protocol and SAP hierarchy
- Further research: Confirmatory research separating primary, secondary and exploratory findings
- Conditions for verification: Distinguish original information on Relative persistent-sleep latency and entry to stages 1 and 2 versus the selected finding from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the relative-latency and sleep-stage supportive findings?
- Application exceptions: Positive supportive latency findings are not converted into success of the absolute sleep-efficiency co-primary endpoint or efficacy of replacing treatment.
- Remaining uncertainty: Exact definitions, effects, CIs, prespecified or exploratory plans, and denominators for supportive findings are unverified.
- Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4; internally defined extension boundaries
- Related sources: R01

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

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The current summary's main findings concern PSG latency, sleep efficiency and supportive latency measures. Separate direct figures for subjective insomnia symptoms, quality of life, daytime function and other sleep outcomes are absent.
- Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Those outcome definitions, effects, CIs, denominators and duration are unverified.
- Reason for missing information: Those outcome definitions, effects, CIs, denominators and duration are unverified.
- Required materials and conditions: Objective selected endpoints versus subjective and everyday outcomes
- Materials to obtain first: Subjective and patient-important outcomes and analysis tables
- Further research: Plans distinguishing PSG, symptoms and function
- Conditions for verification: Distinguish original information on Objective selected endpoints versus subjective and everyday outcomes from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were other sleep outcomes, symptoms and quality of life established?
- Application exceptions: PSG or supportive findings are not promoted into established overall sleep or insomnia-treatment success.
- Remaining uncertainty: Those outcome definitions, effects, CIs, denominators and duration are unverified.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original evidence and Korean and English texts record two PSG endpoints as prespecified co-primary outcomes and describe both as null. This original hierarchy is retained, without new reading or certification of external plans.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Actual hierarchy, dates and success rules in registration versions, protocols and SAPs have not been read.
- Reason for missing information: Actual hierarchy, dates and success rules in registration versions, protocols and SAPs have not been read.
- Required materials and conditions: Original co-primary hierarchy for absolute persistent-sleep latency and absolute sleep efficiency
- Materials to obtain first: Original registration, protocol and SAP versions and outcome plans
- Further research: Research specifying co-primary outcomes and success criteria
- Conditions for verification: Distinguish original information on Original co-primary hierarchy for absolute persistent-sleep latency and absolute sleep efficiency from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Are original prespecified co-primary statements separated from reading external plans?
- Application exceptions: Unread external material does not erase the original prespecification statement or create current prespecification certification.
- Remaining uncertainty: Actual hierarchy, dates and success rules in registration versions, protocols and SAPs have not been read.
- Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: NCT01966211 in the evidence and citation is linked in its original form. External registration, protocol and SAP have not been newly retrieved or read.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Actual registration content, amendments, versions, dates and plans are unverified.
- Reason for missing information: Actual registration content, amendments, versions, dates and plans are unverified.
- Required materials and conditions: Original NCT01966211 identifier versus versions, dates and reading
- Materials to obtain first: Original registration versions, protocol and SAP
- Further research: Records linking plan amendments and published findings
- Conditions for verification: Distinguish original information on Original NCT01966211 identifier versus versions, dates and reading from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What separates the registration identifier from actual registration and plan content?
- Application exceptions: The original identifier and historical Codex full-text cross-check are not promoted into current reading or verification of registration content.
- Remaining uncertainty: Actual registration content, amendments, versions, dates and plans are unverified.
- Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The parent primary-failed and secondary-positive indicator is true, and null co-primary and positive supportive findings are retained as historical context. Whether supportive findings were prespecified secondary or exploratory analyses, and detailed multiplicity handling, remain unverified.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Supportive versus exploratory classification, testing lists, multiplicity and selective-reporting plans are unverified.
- Reason for missing information: Supportive versus exploratory classification, testing lists, multiplicity and selective-reporting plans are unverified.
- Required materials and conditions: Positive supportive findings after primary failure, multiplicity and prespecified analyses
- Materials to obtain first: Protocol, SAP and complete result lists
- Further research: Research fixing the hierarchy of primary, secondary and exploratory outcomes
- Conditions for verification: Distinguish original information on Positive supportive findings after primary failure, multiplicity and prespecified analyses from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were supportive and exploratory findings, multiplicity and selective reporting addressed?
- Application exceptions: Positive supportive findings alone do not replace the selected sleep-efficiency failure or create a new effect judgment.
- Remaining uncertainty: Supportive versus exploratory classification, testing lists, multiplicity and selective-reporting plans are unverified.
- Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application
- Related sources: R01

### N18 · Were randomization, allocation concealment and blinding established?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original design is a prospective randomized sham-controlled trial. Allocation sequence, concealment, participant and assessor blinding, and recognition of conditions are not separately available in the summary.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Sequence generation, concealment, blinding, recognition of conditions and baseline balance are unverified.
- Reason for missing information: Sequence generation, concealment, blinding, recognition of conditions and baseline balance are unverified.
- Required materials and conditions: Actual procedures for the prospective randomized sham comparison
- Materials to obtain first: Allocation and blinding material, baseline tables and protocol
- Further research: Blinding and allocation plans for device-versus-sham comparisons
- Conditions for verification: Distinguish original information on Actual procedures for the prospective randomized sham comparison from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were randomization, allocation concealment and blinding established?
- Application exceptions: The name sham-controlled does not certify successful blinding or absence of bias.
- Remaining uncertainty: Sequence generation, concealment, blinding, recognition of conditions and baseline balance are unverified.
- Referenced methods: M08 §8.1–8.2.3; own application
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original records randomization of 106 adults with insomnia and two nights. Group-specific allocation and completion, and analysis denominators for each PSG endpoint, night and model are not separately presented.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Group-specific flow, completion and analysis, and valid night and endpoint denominators are unverified.
- Reason for missing information: Group-specific flow, completion and analysis, and valid night and endpoint denominators are unverified.
- Required materials and conditions: Overall allocation versus completion, analysis, and night- and endpoint-specific denominators
- Materials to obtain first: Participant flow and night- and outcome-specific analysis tables
- Further research: Plans distinguishing allocation, people, nights and analysis populations
- Conditions for verification: Distinguish original information on Overall allocation versus completion, analysis, and night- and endpoint-specific denominators from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are total 106 and group- and outcome-specific allocation and denominators?
- Application exceptions: 106 participants are not divided into invented group allocations, and two-night observations are not added as new participants.
- Remaining uncertainty: Group-specific flow, completion and analysis, and valid night and endpoint denominators are unverified.
- Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application
- Related sources: R01

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

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original states two nights, but night-specific and aggregated effects, baseline adjustment and repeated-measures correlation handling are not detailed. Nights from the same person are not counted as independent people or trials.
- Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Night-specific data, repeated-measures and aggregation methods, and baseline and period models are unverified.
- Reason for missing information: Night-specific data, repeated-measures and aggregation methods, and baseline and period models are unverified.
- Required materials and conditions: Nights and visits in the same participants, effects of interest and correlation
- Materials to obtain first: Night-specific and baseline data and analysis plans
- Further research: Research specifying repeated observations and participant-level effects of interest
- Conditions for verification: Distinguish original information on Nights and visits in the same participants, effects of interest and correlation from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the analysis units for nights, baseline and repeated measurements, and people?
- Application exceptions: Two-night findings are not duplicated to increase replication counts or sample size.
- Remaining uncertainty: Night-specific data, repeated-measures and aggregation methods, and baseline and period models are unverified.
- Referenced methods: Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application
- Related sources: R01

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

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original 106-person, two-night summary does not separately present group-specific withdrawal, incomplete or ineligible PSG, missing endpoints or handling methods.
- Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Reasons for missingness and discontinuation, denominators, imputation, sensitivity analyses and analysis populations are unverified.
- Reason for missing information: Reasons for missingness and discontinuation, denominators, imputation, sensitivity analyses and analysis populations are unverified.
- Required materials and conditions: Missing participants and nights, reasons for missingness and discontinuation, and handling
- Materials to obtain first: PSG eligibility, participant flow, missing-data handling and SAP
- Further research: Research prespecifying missingness and effects of interest
- Conditions for verification: Distinguish original information on Missing participants and nights, reasons for missingness and discontinuation, and handling from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are withdrawal, incomplete assessments, ineligible PSG and missing data handled?
- Application exceptions: Absent material is not declared zero withdrawal, complete two-night participation, ITT or PP.
- Remaining uncertainty: Reasons for missingness and discontinuation, denominators, imputation, sensitivity analyses and analysis populations are unverified.
- Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original reader answer provides between-group differences for absolute PSG endpoints. Within-group changes, adjustment models, change contrasts and relative supportive analyses are distinguished from these values.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Models, adjustment, baseline values, changes, within-group and between-group contrasts, and supportive definitions are unverified.
- Reason for missing information: Models, adjustment, baseline values, changes, within-group and between-group contrasts, and supportive definitions are unverified.
- Required materials and conditions: Original between-group contrast versus each group's changes, adjustment and models
- Materials to obtain first: Definitions, denominators, models and SAP for each effect of interest
- Further research: Research separating absolute values, changes, relative measures, within-group and between-group contrasts
- Conditions for verification: Distinguish original information on Original between-group contrast versus each group's changes, adjustment and models from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Are within-group, between-group, adjusted, absolute and change effects distinguished?
- Application exceptions: +0.5 percentage points and -7.9 minutes are not transferred into other effects or denominators or newly analyzed.
- Remaining uncertainty: Models, adjustment, baseline values, changes, within-group and between-group contrasts, and supportive definitions are unverified.
- Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.
- Related sources: R01

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

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: Only original active exposure at 14-16°C, sham and two-night information are retained. Actual device operation, wearing, discontinuation, cross-use and concurrent sleep-treatment details are not presented.
- Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Adherence, deviations, shared care, and medication and treatment changes are unverified.
- Reason for missing information: Adherence, deviations, shared care, and medication and treatment changes are unverified.
- Required materials and conditions: Actual device operation, wearing, discontinuation and shared conditions
- Materials to obtain first: Device logs, exposure, shared treatment and deviation records
- Further research: Research distinguishing actual exposure from assignment effects of interest
- Conditions for verification: Distinguish original information on Actual device operation, wearing, discontinuation and shared conditions from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are actual device exposure, adherence, deviations and concurrent treatment?
- Application exceptions: Original device exposure is not turned into implementation or sleep and insomnia treatment-replacement instructions.
- Remaining uncertainty: Adherence, deviations, shared care, and medication and treatment changes are unverified.
- Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: Original funding information records NIH/NHLBI support, Ebb Therapeutics device and study involvement, and company founder and executive authorship. Public support does not erase developer involvement or guarantee independence.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Financial and in-kind support, design, analysis and data-access roles, and detailed disclosures are unverified.
- Reason for missing information: Financial and in-kind support, design, analysis and data-access roles, and detailed disclosures are unverified.
- Required materials and conditions: NIH/NHLBI and Ebb Therapeutics support and author roles
- Materials to obtain first: Support, author-interest and role disclosures
- Further research: Explicit reporting of support and design and analysis roles
- Conditions for verification: Distinguish original information on NIH/NHLBI and Ebb Therapeutics support and author roles from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What original information describes developer and public support and author interests?
- Application exceptions: Original historical I0 and B2 are not inherited as new review findings, and support information alone does not change judgments on the figures.
- Remaining uncertainty: Financial and in-kind support, design, analysis and data-access roles, and detailed disclosures are unverified.
- Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The Roth2018 report is linked through one existing evidence entry and one citation entry. Active and sham groups, two nights, co-primary and supportive outcomes, and latency and sleep-efficiency sheets share the same original context and are not added as new independent trials or participants.
- Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Related report/trial relationships and unique trial/participant totals are unverified.
- Reason for missing information: Related report/trial relationships and unique trial/participant totals are unverified.
- Required materials and conditions: The single Roth2018 reference and trial versus duplicate observations
- Materials to obtain first: Trial and report identity, related reports and observation units
- Further research: Records distinguishing reports from study families
- Conditions for verification: Distinguish original information on The single Roth2018 reference and trial versus duplicate observations from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are reports, trials, related claims, nights and groups linked within the same family?
- Application exceptions: One report entry is not certification of a final count of clinical independence.
- Remaining uncertainty: Related report/trial relationships and unique trial/participant totals are unverified.
- Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
- Related sources: R01

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

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The parent records the context of one small two-night trial and absent long-term confirmation. Other independent research has not been searched or verified here.
- Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Populations, devices, endpoints, duplication and independence of separate direct reports are unverified.
- Reason for missing information: Populations, devices, endpoints, duplication and independence of separate direct reports are unverified.
- Required materials and conditions: Direct independent research on the same absolute sleep-efficiency question
- Materials to obtain first: Direct confirmatory reports and trial identity
- Further research: Separate confirmatory research addressing the same question
- Conditions for verification: Distinguish original information on Direct independent research on the same absolute sleep-efficiency question from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What independent confirmation or replication supports selected sleep efficiency?
- Application exceptions: An original single-trial statement is not converted into verification of no current research worldwide, and related sheets are not counted as independent replication.
- Remaining uncertainty: Populations, devices, endpoints, duplication and independence of separate direct reports are unverified.
- Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The material concerns the original device and adults with insomnia over two nights. Direct effects or durations for other devices, ordinary cold packs, ages, diseases or baseline-sleep groups are not presented.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Direct population, device, subgroup and long-term findings and interactions are unverified.
- Reason for missing information: Direct population, device, subgroup and long-term findings and interactions are unverified.
- Required materials and conditions: Extrapolation beyond the original device and population to general cooling and subgroups
- Materials to obtain first: Direct population- and device-specific material and prespecified subgroup plans
- Further research: Research specifying direct applicability
- Conditions for verification: Distinguish original information on Extrapolation beyond the original device and population to general cooling and subgroups from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Can findings apply to other devices, populations, durations or subgroups?
- Application exceptions: No new claims of null effects for every cooling method, specific-population benefits, or device recommendations and use instructions are created.
- Remaining uncertainty: Direct population, device, subgroup and long-term findings and interactions are unverified.
- Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are internally designed
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: Current PSG sleep-efficiency and latency material and supportive signals have a short-term scope. Long-term insomnia course, daytime function, quality of life and treatment-replacement effects require separate material.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Direct persistence, post-discontinuation, patient-important and treatment-replacement outcomes are unverified.
- Reason for missing information: Direct persistence, post-discontinuation, patient-important and treatment-replacement outcomes are unverified.
- Required materials and conditions: Two-night objective measures versus symptoms, everyday function and persistence
- Materials to obtain first: Long-term and patient-important outcomes and follow-up
- Further research: Research separating PSG from long-term clinical questions
- Conditions for verification: Distinguish original information on Two-night objective measures versus symptoms, everyday function and persistence from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Are PSG findings distinguished from long-term and patient-important insomnia effects?
- Application exceptions: Positive supportive latency findings are not extended into drug-like efficacy, replacement of treatment or long-term success.
- Remaining uncertainty: Direct persistence, post-discontinuation, patient-important and treatment-replacement outcomes are unverified.
- Referenced methods: M03 §3.2.4; internally defined extension boundaries; M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are internally designed
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The complete stored verdict 2982 summary was read for production and saved as a copy. Original PubMed URL, PMCID and NCT identifiers link sources; external content and links have not been newly accessed or verified.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Current verification of detailed external original methods, findings, registration and plans is incomplete.
- Reason for missing information: Current verification of detailed external original methods, findings, registration and plans is incomplete.
- Required materials and conditions: Local stored summary versus external abstract, full text and plans
- Materials to obtain first: Obtained original material and actual reading and update events
- Further research: Records separating summary preservation from new acquisition and reading
- Conditions for verification: Distinguish original information on Local stored summary versus external abstract, full text and plans from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What has actually been obtained and read, and what do URLs and registration links mean?
- Application exceptions: Presence of a URL, PMCID or NCT identifier is not presented as external acquisition, reading or a successful link check.
- Remaining uncertainty: Current verification of detailed external original methods, findings, registration and plans is incomplete.
- Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: Complete Korean and English texts, reference date 2026-09-07, an empty correction array, empty deliberation string and parent D with 28 points are retained. Axes B/S/R1/I0/E0/B2/C0, a true primary-failed and secondary-positive indicator, three other false indicators, and empty grade-override reasons are history.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Detailed external translation and comparisons with original texts, corrections and registration were not performed here.
- Reason for missing information: Detailed external translation and comparisons with original texts, corrections and registration were not performed here.
- Required materials and conditions: Original language texts, dates, corrections, axes and verification statements
- Materials to obtain first: Original texts, language-specific changes, dates and correction events
- Further research: Separation of original-value preservation from new evidence and changes
- Conditions for verification: Distinguish original information on Original language texts, dates, corrections, axes and verification statements from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are Korean and English texts, dates, corrections, empty values and historical axes preserved?
- Application exceptions: Historical Codex full-text cross-checking is not inherited as passed current clinical review or external reading.
- Remaining uncertainty: Detailed external translation and comparisons with original texts, corrections and registration were not performed here.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The safety description records broadly similar adverse-event patterns to sham over two nights, with headache and other events reported. Collection, classification, severity and the full event scope are not detailed.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Collection, definitions, severity, complete harm events and discontinuation tables are unverified.
- Reason for missing information: Collection, definitions, severity, complete harm events and discontinuation tables are unverified.
- Required materials and conditions: Active and passive collection, event definitions, severity and discontinuation
- Materials to obtain first: Harm-collection plans and complete event and discontinuation tables
- Further research: Research specifying harm collection separately from efficacy
- Conditions for verification: Distinguish original information on Active and passive collection, event definitions, severity and discontinuation from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were adverse-event collection, definitions and scope established?
- Application exceptions: A statement of similar patterns is not converted into zero harms, equivalent safety or absence of every risk.
- Remaining uncertainty: Collection, definitions, severity, complete harm events and discontinuation tables are unverified.
- Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP
- Related sources: R01

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

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original states only that headache and other events were reported. Active or sham group, numbers of people and events, severity and attribution are not separately established in the summary.
- Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Group-specific headache counts, valid denominators, severity, causality and timing are unverified.
- Reason for missing information: Group-specific headache counts, valid denominators, severity, causality and timing are unverified.
- Required materials and conditions: Headache groups, people, events, attribution and denominators
- Materials to obtain first: Headache and other event tables, collection denominators and attribution records
- Further research: Harm research with explicit event, person and exposure units
- Conditions for verification: Distinguish original information on Headache groups, people, events, attribution and denominators from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Which group, event and denominator does the headache report refer to?
- Application exceptions: Headache is not transferred into a confirmed active-group event, and absent counts or incidence rates are not invented.
- Remaining uncertainty: Group-specific headache counts, valid denominators, severity, causality and timing are unverified.
- Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are internally designed; M19 §19.1.2–19.2.4; Internal application; Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool
- Related sources: R01

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

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original records broadly similar acute tolerability to sham. Group-specific harm-collection and event denominators, effects, CIs and equivalence tests are not presented.
- Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Group- and night-specific harm denominators, events, exposure and comparison CIs are unverified.
- Reason for missing information: Group- and night-specific harm denominators, events, exposure and comparison CIs are unverified.
- Required materials and conditions: Group-specific collection populations, event and exposure denominators, and comparisons
- Materials to obtain first: Harm-flow and group-specific tables and comparative analyses
- Further research: Plans distinguishing efficacy populations from harm-collection populations
- Conditions for verification: Distinguish original information on Group-specific collection populations, event and exposure denominators, and comparisons from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are short-term harm-comparison denominators, differences and CIs?
- Application exceptions: 106 participants and two nights are not automatically used as valid harm denominators or declared equivalence or zero difference.
- Remaining uncertainty: Group- and night-specific harm denominators, events, exposure and comparison CIs are unverified.
- Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: Original two-night tolerability is retained, but exact headache and event timing and delayed or long-term post-treatment observations are absent from the summary. The original states this is not material for determining long-term safety.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Harms by time and duration, and long-term and post-discontinuation material are unverified.
- Reason for missing information: Harms by time and duration, and long-term and post-discontinuation material are unverified.
- Required materials and conditions: Exposure and event timing and post-discontinuation follow-up
- Materials to obtain first: Harm and exposure timing and subsequent follow-up
- Further research: Research prespecifying delayed and long-term harms
- Conditions for verification: Distinguish original information on Exposure and event timing and post-discontinuation follow-up from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are harm timing and delayed or long-term findings after two nights?
- Application exceptions: Similar two-night tolerability is not extended into safety of repeated or long-term use.
- Remaining uncertainty: Harms by time and duration, and long-term and post-discontinuation material are unverified.
- Referenced methods: M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application
- Related sources: R01

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

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original supplies device, sham and headache context. Specific device and exposure details, alternative causes involving medical history and medications, and event attribution are absent from the summary.
- Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Actual event-specific exposure, medical history, concurrent treatment, attribution and alternative causes are unverified.
- Reason for missing information: Actual event-specific exposure, medical history, concurrent treatment, attribution and alternative causes are unverified.
- Required materials and conditions: Temperature, pressure and other exposure, alternative causes and concurrent conditions
- Materials to obtain first: Device logs, medical history, medications and event-assessment records
- Further research: Harm plans distinguishing exposure of interest from alternative causes
- Conditions for verification: Distinguish original information on Temperature, pressure and other exposure, alternative causes and concurrent conditions from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What links harms to the device, sham, medical history or medications?
- Application exceptions: Pressure, skin injury, causes, prevention or care absent from the summary are not added as new clinical facts.
- Remaining uncertainty: Actual event-specific exposure, medical history, concurrent treatment, attribution and alternative causes are unverified.
- Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation
- Related sources: R01

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

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The original 106-person, two-night and tolerability descriptions do not separately describe harm-related discontinuation or collection and handling for people with missing data.
- Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Group-specific discontinuation and missingness reasons, their relation to harms and missing-data handling are unverified.
- Reason for missing information: Group-specific discontinuation and missingness reasons, their relation to harms and missing-data handling are unverified.
- Required materials and conditions: Discontinuation and missingness reasons, completion of harm collection and denominators
- Materials to obtain first: Discontinuation, participant flow, harm collection and missing-data material
- Further research: Plans distinguishing missingness from harm-related discontinuation
- Conditions for verification: Distinguish original information on Discontinuation and missingness reasons, completion of harm collection and denominators from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were harm-related discontinuation and missing PSG established?
- Application exceptions: Absent material is not converted into zero discontinuation, zero missingness or safety of every completer.
- Remaining uncertainty: Group-specific discontinuation and missingness reasons, their relation to harms and missing-data handling are unverified.
- Referenced methods: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application
- Related sources: R01

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

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: The current preserved list concerns this two-night efficacy-trial report. Separate harm reports have not been searched or obtained here; safety statements from related claims or nights are not counted as independent reports.
- Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Identity, populations, devices, durations and duplication of independent harm reports are unverified.
- Reason for missing information: Identity, populations, devices, durations and duplication of independent harm reports are unverified.
- Required materials and conditions: Independent harm reports for the same device, population and duration
- Materials to obtain first: Separate harm/surveillance and event information
- Further research: Independent safety research specifying population, device and exposure
- Conditions for verification: Distinguish original information on Independent harm reports for the same device, population and duration from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Was independent harm evidence or separate event material obtained?
- Application exceptions: No separate current entry does not establish absence of every external harm report.
- Remaining uncertainty: Identity, populations, devices, durations and duplication of independent harm reports are unverified.
- Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations
- Related sources: R01

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

Verification status: Unverified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: Two-night material in adults with insomnia is not used to judge other diseases, populations, repeated use or long-term harms. Original safety caution and long-term limitations are retained.
- Why unverified: Required direct material has not been verified within the current summary and unread-external-material scope. Direct harm outcomes for vulnerable populations, diseases and repeated or long-term exposure are unverified.
- Reason for missing information: Direct harm outcomes for vulnerable populations, diseases and repeated or long-term exposure are unverified.
- Required materials and conditions: Population- and disease-specific and long-term device-safety scope
- Materials to obtain first: Population-specific medical history, exposure and direct harm material
- Further research: Research specifying population and repeated or long-term safety questions
- Conditions for verification: Distinguish original information on Population- and disease-specific and long-term device-safety scope from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What is known about safety in vulnerable populations, other diseases and repeated exposure?
- Application exceptions: No new eligibility, device-setting, cooling, sleep-care or insomnia-treatment instructions are created.
- Remaining uncertainty: Direct harm outcomes for vulnerable populations, diseases and repeated or long-term exposure are unverified.
- Referenced methods: M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: Null absolute sleep efficiency, broadly similar short-term tolerability to sham, headache reports and parent safety caution are recorded separately. Failed efficacy does not establish harm or certify harmlessness.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Comparative and causal safety and direct long-term material are unverified.
- Reason for missing information: Comparative and causal safety and direct long-term material are unverified.
- Required materials and conditions: Separation of sleep efficiency, harm comparisons, original caution and causality
- Materials to obtain first: Harm, causality and follow-up material separate from efficacy
- Further research: Plans separating different effects of interest and outcomes
- Conditions for verification: Distinguish original information on Separation of sleep efficiency, harm comparisons, original caution and causality from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are null PSG efficacy and safety or causal judgments separated?
- Application exceptions: Null sleep efficiency is not converted into safety benefits or harms, or treatment-replacement instructions.
- Remaining uncertainty: Comparative and causal safety and direct long-term material are unverified.
- Referenced methods: Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries
- Related sources: R01

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

Verification status: Partly verified  
Reading scope: Summary read; external materials unread, access not attempted

- Current findings: Conditions were preserved and frozen before separate application. Existing candidate review-pending and production-eligibility indicators are retained as history. Current content and claim-boundary review is incomplete, with false completion indicators, zero new units and an unrecorded final independent count.
- Why unverified: Some information from the original summary is linked for production; clinical verification and content review are not complete. Subsequent original material, actual reading and change events, and final user decisions on review and independence are not yet available.
- Reason for missing information: Subsequent original material, actual reading and change events, and final user decisions on review and independence are not yet available.
- Required materials and conditions: Identity, units and denominators, outcome hierarchy, reading and change events, and original candidates
- Materials to obtain first: Additional original material, before-and-after values, versions and decision records
- Further research: Research directly addressing the selected absolute sleep-efficiency gap
- Conditions for verification: Distinguish original information on Identity, units and denominators, outcome hierarchy, reading and change events, and original candidates from unverified details and extensions to other sleep outcomes, harms and long-term findings.
- Why this condition is needed: This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are subsequent material, condition versions, historical candidates and incomplete review linked?
- Application exceptions: Historical full-text cross-checking or completed production is not invented as current model or clinical content review or completed publication.
- Remaining uncertainty: Subsequent original material, actual reading and change events, and final user decisions on review and independence are not yet available.
- Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application
- Related sources: R01

## Evidence and sources

### R01

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

[PubMed](https://pubmed.ncbi.nlm.nih.gov/29648642/)

Materials actually read: Summary read; external materials unread, access not attempted  
Findings recorded in the summary: -7.9 minutes (95% CI -18.4 to 2.6), P=.092; +0.5 percentage points (-3.4 to 4.5), P=.759  
Record level: Selected absolute sleep efficiency +0.5 percentage points (CI -3.4 to 4.5), P=.759 is the original between-group finding. Latency -7.9 minutes (CI -18.4 to 2.6), P=.092 is related-claim context. Group-specific absolute values and changes, night-specific denominators and adjustment details are unverified. Positive supportive latency findings concern other outcomes.  
Independent replication: Link Roth2018 active and sham groups, people, two nights, absolute, supportive and co-primary findings, and parent, latency and sleep-efficiency sheets within the same trial and reference. These are not added as new independent trials or participants.

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

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

## What the statuses mean

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

## Change history

2026-10-15 · Public page/materials 1.0. The public page and data were prepared from the existing 40 items. No new clinical search, verification-status change or scoring was performed.