{ "schema_version": "chamgap-public-criteria-1.0", "title": "Forehead-cooling device × Absolute latency to persistent sleep: Null co-primary findings and separate supportive measures", "language": "en", "translation_date": "2026-10-15", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." } ], "status_dictionary": { "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Review of existing content incomplete", "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which existing absolute-latency claim is being presented?", "needed": "Separate the selected subclaim wording and original grade from parent context", "role": "Required", "role_reason": "This is needed to connect separate the selected subclaim wording and original grade from parent context with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on separate the selected subclaim wording and original grade from parent context, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: The selected endpoint's exact definition and effect of interest, and review of the claim boundary. Parent scores are not used to fill subclaim scores. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which population with insomnia produced these findings?", "needed": "Diagnosed adults, eligibility and concurrent exposures", "role": "Required", "role_reason": "This is needed to connect diagnosed adults, eligibility and concurrent exposures with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on diagnosed adults, eligibility and concurrent exposures, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original eligibility and exclusion criteria, diagnostic criteria, baseline characteristics, medication and concurrent treatment, and adherence. Application is not extended to every sleep problem. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Is the active device equivalent to an ordinary cold pack?", "needed": "Study device and actual active intervention", "role": "Required", "role_reason": "This is needed to connect study device and actual active intervention with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on study device and actual active intervention, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Actual device model and settings, exposure, duration of use, adherence and product-support material. No new equivalence with other cooling or sleep devices or instructions for use are produced. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What were the actual sham-device control conditions?", "needed": "Sham device, measurement and concurrent treatment", "role": "Required", "role_reason": "This is needed to connect sham device, measurement and concurrent treatment with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on sham device, measurement and concurrent treatment, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original active and sham implementation, allocation concealment, blinding, sensation and expectations, and concurrent exposures in both groups. Sham is not substituted with no intervention or an ordinary cold pack. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "How many nights were used to assess efficacy?", "needed": "Measurement nights, duration and repeated measurements", "role": "Required", "role_reason": "This is needed to connect measurement nights, duration and repeated measurements with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on measurement nights, duration and repeated measurements, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Actual PSG measurement schedules, baseline and treatment nights, repeated-measures models and long-term follow-up. No new total night count or observation time is calculated. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What exactly defines latency to persistent sleep?", "needed": "PSG absolute latency to persistent sleep", "role": "Required", "role_reason": "This is needed to connect PSG absolute latency to persistent sleep with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on PSG absolute latency to persistent sleep, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original PSG LPS definitions, scoring blinding, stage and continuity rules, measurement times and analysis units. Subjective sleep onset or entry into a sleep stage is not substituted for LPS. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are absolute results distinguished from relative changes?", "needed": "Effects of interest for absolute LPS and relative sleep-latency change", "role": "Required", "role_reason": "This is needed to connect effects of interest for absolute LPS and relative sleep-latency change with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on effects of interest for absolute LPS and relative sleep-latency change, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original formulas, denominators, analysis models, prespecified hierarchy and endpoint-specific effects and CIs for absolute values, change from baseline and relative change. No new conversion is calculated. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What are the selected absolute-LPS between-group effect and uncertainty?", "needed": "Original LPS between-group difference, CI and P value", "role": "Required", "role_reason": "This is needed to connect original LPS between-group difference, CI and P value with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on original LPS between-group difference, CI and P value, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original effect of interest, analysis population, models, CI and P calculations, and separate confirmatory material. No new effect, CI, P value or quantitative example is calculated. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Is the co-primary sleep-efficiency result separated from LPS?", "needed": "The other co-primary PSG endpoint", "role": "Required", "role_reason": "This is needed to connect the other co-primary PSG endpoint with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on the other co-primary PSG endpoint, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Sleep-efficiency calculations, denominators, models, co-primary specifications and endpoint-specific analysis material. Percentage points are not converted into minutes or event effects. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "How do prespecified co-primary success criteria relate to supportive findings?", "needed": "Failure of both co-primary endpoints and prespecified plans", "role": "Required", "role_reason": "This is needed to connect failure of both co-primary endpoints and prespecified plans with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on failure of both co-primary endpoints and prespecified plans, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Registration, protocol and SAP versions and dates, co-primary success rules, multiplicity plans and amendment history. No new trial-success or grade judgment. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Were actual group-specific absolute latency values provided?", "needed": "Baseline and final absolute values by group versus between-group differences", "role": "Required", "role_reason": "This is needed to connect baseline and final absolute values by group versus between-group differences with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on baseline and final absolute values by group versus between-group differences, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Baseline and final LPS values by group and measurement night, variance, analysis populations, models and missingness. No new group values, rates or changes are calculated. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What is the positive relative-latency signal?", "needed": "Relative-latency supportive analysis versus the absolute primary result", "role": "Supplementary", "role_reason": "This is needed to connect relative-latency supportive analysis versus the absolute primary result with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on relative-latency supportive analysis versus the absolute primary result, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original tables, definitions, denominators, effects and CIs, prespecified hierarchy and multiplicity plans for that relative measure. The signal is not promoted into established long-term efficacy. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Is latency to sleep stages 1 and 2 the same as latency to persistent sleep?", "needed": "Distinguish supportive measures for each sleep stage", "role": "Supplementary", "role_reason": "This is needed to connect distinguish supportive measures for each sleep stage with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on distinguish supportive measures for each sleep stage, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Stage-specific PSG definitions, original findings, denominators, measurement nights, primary and supportive hierarchy and multiplicity plans. Stage-specific findings are not added as new participants or trials. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Is material available to assess selection and multiplicity of supportive findings?", "needed": "Retain positive supportive measures together with failed primary findings", "role": "Required", "role_reason": "This is needed to connect retain positive supportive measures together with failed primary findings with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on retain positive supportive measures together with failed primary findings, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Complete endpoint lists, registration and SAP, amendment history, all findings, multiple-testing plans and comparisons with the paper. No new formal RoB assessment or rejudging. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Do 106 participants form the analysis denominator for every endpoint?", "needed": "Allocation, analysis, completion, withdrawal and night-specific missingness", "role": "Required", "role_reason": "This is needed to connect allocation, analysis, completion, withdrawal and night-specific missingness with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on allocation, analysis, completion, withdrawal and night-specific missingness, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Group-specific flow diagrams, analysis populations, missing data by night and endpoint, withdrawal reasons and handling. No new 53/53 allocation, completion count, missing-data count or rate, or total night count is created. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are within-group improvements separated from the between-group effect of interest?", "needed": "Active-versus-sham comparison and change from baseline", "role": "Required", "role_reason": "This is needed to connect active-versus-sham comparison and change from baseline with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on active-versus-sham comparison and change from baseline, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original baseline and final group values, prespecified estimands, repeated-measures and adjustment models, concurrent exposures and sham responses. No new difference or ratio is calculated. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N17", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What is the scope of two-night harms and tolerability statements?", "needed": "Short-term AE patterns versus long-term safety", "role": "Supplementary", "role_reason": "This is needed to connect short-term AE patterns versus long-term safety with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on short-term AE patterns versus long-term safety, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: AE collection methods, group-specific exposure and harm denominators, headache and other events, discontinuation, attribution and long-term harms. No new harm rates or device-care or implementation instructions. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N18", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Do findings extend to long-term sleep efficacy and safety?", "needed": "Two-night effects versus persistence and long-term outcomes", "role": "Supplementary", "role_reason": "This is needed to connect two-night effects versus persistence and long-term outcomes with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on two-night effects versus persistence and long-term outcomes, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Longer active-versus-sham confirmatory trials with prespecified absolute LPS, clinical sleep and function, long-term exposure and harms, discontinuation and recurrence. No device, cooling, sleep-care or treatment-replacement implementation instructions are provided. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What materials were actually read in this work?", "needed": "Stored summary and access status of external material", "role": "Required", "role_reason": "This is needed to connect stored summary and access status of external material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on stored summary and access status of external material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What does the registration number establish?", "needed": "Registration identifier in references and evidence versus actual registration reading", "role": "Required", "role_reason": "This is needed to connect registration identifier in references and evidence versus actual registration reading with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on registration identifier in references and evidence versus actual registration reading, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Were the protocol and SAP acquired?", "needed": "Separate entries for prespecified plans, amendments and analysis material", "role": "Required", "role_reason": "This is needed to connect separate entries for prespecified plans, amendments and analysis material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on separate entries for prespecified plans, amendments and analysis material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are funding, support, authors and research involvement separated?", "needed": "Four categories of company involvement versus public and academic support", "role": "Required", "role_reason": "This is needed to connect four categories of company involvement versus public and academic support with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on four categories of company involvement versus public and academic support, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Separate original funding sources, food or device support, employee and executive authors, design, analysis and data control, and conflicts of interest. Original independence axes are not used as new independence certification. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are unmeasured outcomes, unverified details and null results distinguished?", "needed": "Reasons for question-specific result and access statuses", "role": "Required", "role_reason": "This is needed to connect reasons for question-specific result and access statuses with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on reasons for question-specific result and access statuses, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Material to establish direct measurement, original tables, analysis plans and material access. Unread material is not substituted for unreported findings, zero studies or zero effects. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are reports, trials, people, measurements and related sheets separated?", "needed": "Reference linkage and meaning without double counting", "role": "Required", "role_reason": "This is needed to connect reference linkage and meaning without double counting with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on reference linkage and meaning without double counting, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Is there evidence of separate independent replication?", "needed": "Report identity versus independent confirmation", "role": "Supplementary", "role_reason": "This is needed to connect report identity versus independent confirmation with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on report identity versus independent confirmation, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Reports with separate prespecified plans, populations, interventions and controls, direct endpoints, follow-up, effects and CIs, and funding and author relationships appropriate to the question. No new search or independence adjudication. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are subclaim grades separated from parent scores and axes?", "needed": "Selected-record absences versus the parent verdict", "role": "Required", "role_reason": "This is needed to connect selected-record absences versus the parent verdict with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on selected-record absences versus the parent verdict, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are Korean, English and classification scopes preserved as the same original record?", "needed": "Original Korean and English texts and structured fields", "role": "Required", "role_reason": "This is needed to connect original Korean and English texts and structured fields with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on original Korean and English texts and structured fields, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Material for review of differences in original languages, selected and parent claims, terminology, visits and measurement definitions. General wording is not extended into new clinical proof. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are reference dates, corrections and historical verification separated?", "needed": "Original reference date versus creation and application times", "role": "Required", "role_reason": "This is needed to connect original reference date versus creation and application times with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on original reference date versus creation and application times, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: If new material or corrections arise, preserve original text and separate events, conditions and observations, and verdict decisions for review. Existing records are not retrospectively certified. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What material would directly fill this gap?", "needed": "Question-specific direct comparisons, follow-up and denominator material", "role": "Supplementary", "role_reason": "This is needed to connect question-specific direct comparisons, follow-up and denominator material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on question-specific direct comparisons, follow-up and denominator material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Prespecified absolute LPS and co-primary plans, actual active and sham exposure, PSG measurements and denominators, models, effects and CIs, and long-term sleep and harm material. Only the need for material or research is recorded; no new retrieval or research is performed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Is production separated from content review and implementation advice?", "needed": "Production request and responsibility for review of existing content", "role": "Supplementary", "role_reason": "This is needed to connect production request and responsibility for review of existing content with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the absolute LPS between-group difference, each group's absolute values, changes and relative measures, co-primary and supportive findings, PSG definitions, sleep efficiency and stages, active and sham exposure, population, nights and denominators, harms and developer involvement. Only original numbers are retained. No new calculations, hypothetical quantitative examples, effects, CIs, grades, rejudging or independence certification, or diet, device or treatment implementation instructions are produced.", "criterion": "Present original data on production request and responsibility for review of existing content, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Review of existing content and subsequent actual material and correction records. During the original production, clinical original-material comparisons, external reading, new calculations, grade changes, and device, diet or treatment implementation advice were not performed. Only the need for material or research is recorded; no new retrieval or research is performed." } ] }