{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Forehead-cooling device × Absolute sleep efficiency: The original null result and remaining evidence gaps",
  "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    }
  ],
  "status_dictionary": {
    "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.",
    "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.",
    "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.",
    "Review incomplete": "Review of existing content or actual review incomplete.",
    "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.",
    "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.",
    "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.",
    "Not applicable": "Used when the reason it does not apply to the original question is stated.",
    "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "How is the selected sleep-efficiency claim distinguished from the related latency claim?",
      "needed": "Sleep-efficiency question and verdict record versus parent and latency context",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How is the selected sleep-efficiency claim distinguished from the related latency claim?",
      "application_exception": "Related claims and co-primary context do not add new units to the selected question.",
      "criterion": "Distinguish original information on Sleep-efficiency question and verdict record versus parent and latency context from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "A prespecified plan distinguishing sleep-efficiency and latency effects of interest"
    },
    {
      "item_id": "N02",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What are the subclaim grade, note and absent values?",
      "needed": "Subclaim D and note, absent score, status and axes, and parent history",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the subclaim grade, note and absent values?",
      "application_exception": "Parent 28 points and axes such as C0 are not transferred into subclaim scores or axes, or a passed current review.",
      "criterion": "Distinguish original information on Subclaim D and note, absent score, status and axes, and parent history from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Records separating existing grades and values from updates with additional evidence"
    },
    {
      "item_id": "N03",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Which people with insomnia were studied?",
      "needed": "Diagnosed adults with insomnia and recruitment and baseline scope",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Which people with insomnia were studied?",
      "application_exception": "Efficacy is not newly extended to other sleep disorders, vulnerable populations or the general population.",
      "criterion": "Distinguish original information on Diagnosed adults with insomnia and recruitment and baseline scope from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying the population with insomnia"
    },
    {
      "item_id": "N04",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Were comorbidities, medications and baseline sleep established?",
      "needed": "Baseline insomnia, medication and concurrent treatment, and assessment criteria",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were comorbidities, medications and baseline sleep established?",
      "application_exception": "Use, discontinuation or replacement of sleep medication or other treatments is not added to the original study.",
      "criterion": "Distinguish original information on Baseline insomnia, medication and concurrent treatment, and assessment criteria from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying shared conditions and concurrent treatment"
    },
    {
      "item_id": "N05",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What distinguishes the active device from an ordinary cold pack?",
      "needed": "Device type, active temperature and study exposure",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What distinguishes the active device from an ordinary cold pack?",
      "application_exception": "14-16°C is not converted into instructions for device settings, forehead cooling or cold packs.",
      "criterion": "Distinguish original information on Device type, active temperature and study exposure from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying the device and active exposure"
    },
    {
      "item_id": "N06",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What were the sham-device control conditions?",
      "needed": "Sham design, exposure and comparison, and feasibility of blinding",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What were the sham-device control conditions?",
      "application_exception": "Sham is not substituted with no treatment, a specified temperature, or a direct comparison with sleep medication.",
      "criterion": "Distinguish original information on Sham design, exposure and comparison, and feasibility of blinding from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction markers and assessment adaptation are internally designed; M08 §8.1–8.2.3; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying the sham intervention and comparison of interest"
    },
    {
      "item_id": "N07",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "How are two-night exposure and measurement separated from lasting effects?",
      "needed": "Actual measurement nights, exposure duration, and baseline and follow-up schedules",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are two-night exposure and measurement separated from lasting effects?",
      "application_exception": "Two nights are not counted as separate independent trials or additional participants, or extended into ongoing-use effects.",
      "criterion": "Distinguish original information on Actual measurement nights, exposure duration, and baseline and follow-up schedules from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research distinguishing baseline, measurement nights and follow-up in advance"
    },
    {
      "item_id": "N08",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "How is absolute sleep efficiency defined and measured by PSG?",
      "needed": "Sleep-efficiency definition, measurement and calculation units, and assessment procedures",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How is absolute sleep efficiency defined and measured by PSG?",
      "application_exception": "Percentage points are not converted into relative percentages, minutes asleep or individual efficacy.",
      "criterion": "Distinguish original information on Sleep-efficiency definition, measurement and calculation units, and assessment procedures from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research with explicit sleep-efficiency and measurement plans"
    },
    {
      "item_id": "N09",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What are the original sleep-efficiency between-group difference, CI and P value?",
      "needed": "Original comparison of +0.5 percentage points, 95% CI -3.4 to 4.5, P=.759",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the original sleep-efficiency between-group difference, CI and P value?",
      "application_exception": "The original null result is not newly judged as an exactly zero effect, equivalence or nonresponse in every person.",
      "criterion": "Distinguish original information on Original comparison of +0.5 percentage points, 95% CI -3.4 to 4.5, P=.759 from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research prespecifying effects of interest, intervals and measurement nights"
    },
    {
      "item_id": "N10",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Were group-specific absolute, baseline and final values and changes established?",
      "needed": "Group-specific sleep efficiency, baseline, final values and changes, and adjustment",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were group-specific absolute, baseline and final values and changes established?",
      "application_exception": "The between-group +0.5 percentage points is not copied as each group's change or an individual's increase.",
      "criterion": "Distinguish original information on Group-specific sleep efficiency, baseline, final values and changes, and adjustment from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Plans distinguishing absolute values and changes, and within-group and between-group comparisons"
    },
    {
      "item_id": "N11",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "How are the original CI and null statement separated from importance?",
      "needed": "Precision, importance, the original null result and clinical interpretation",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are the original CI and null statement separated from importance?",
      "application_exception": "A P value alone does not create new precision certification or equivalence or safety judgments.",
      "criterion": "Distinguish original information on Precision, importance, the original null result and clinical interpretation from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research prespecifying intervals, importance and effects of interest"
    },
    {
      "item_id": "N12",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What is the context of the related absolute-latency claim?",
      "needed": "Different units and effects for latency and selected sleep efficiency",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What is the context of the related absolute-latency claim?",
      "application_exception": "Related findings and the same report are not added as new independent trials or participants.",
      "criterion": "Distinguish original information on Different units and effects for latency and selected sleep efficiency from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internal extension boundaries",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Plans distinguishing latency and sleep efficiency"
    },
    {
      "item_id": "N13",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What are the relative-latency and sleep-stage supportive findings?",
      "needed": "Relative persistent-sleep latency and entry to stages 1 and 2 versus the selected finding",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the relative-latency and sleep-stage supportive findings?",
      "application_exception": "Positive supportive latency findings are not converted into success of the absolute sleep-efficiency co-primary endpoint or efficacy of replacing treatment.",
      "criterion": "Distinguish original information on Relative persistent-sleep latency and entry to stages 1 and 2 versus the selected finding from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4; internally defined extension boundaries",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Confirmatory research separating primary, secondary and exploratory findings"
    },
    {
      "item_id": "N14",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Were other sleep outcomes, symptoms and quality of life established?",
      "needed": "Objective selected endpoints versus subjective and everyday outcomes",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were other sleep outcomes, symptoms and quality of life established?",
      "application_exception": "PSG or supportive findings are not promoted into established overall sleep or insomnia-treatment success.",
      "criterion": "Distinguish original information on Objective selected endpoints versus subjective and everyday outcomes from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Plans distinguishing PSG, symptoms and function"
    },
    {
      "item_id": "N15",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Are original prespecified co-primary statements separated from reading external plans?",
      "needed": "Original co-primary hierarchy for absolute persistent-sleep latency and absolute sleep efficiency",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Are original prespecified co-primary statements separated from reading external plans?",
      "application_exception": "Unread external material does not erase the original prespecification statement or create current prespecification certification.",
      "criterion": "Distinguish original information on Original co-primary hierarchy for absolute persistent-sleep latency and absolute sleep efficiency from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying co-primary outcomes and success criteria"
    },
    {
      "item_id": "N16",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What separates the registration identifier from actual registration and plan content?",
      "needed": "Original NCT01966211 identifier versus versions, dates and reading",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What separates the registration identifier from actual registration and plan content?",
      "application_exception": "The original identifier and historical Codex full-text cross-check are not promoted into current reading or verification of registration content.",
      "criterion": "Distinguish original information on Original NCT01966211 identifier versus versions, dates and reading from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Records linking plan amendments and published findings"
    },
    {
      "item_id": "N17",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Were supportive and exploratory findings, multiplicity and selective reporting addressed?",
      "needed": "Positive supportive findings after primary failure, multiplicity and prespecified analyses",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were supportive and exploratory findings, multiplicity and selective reporting addressed?",
      "application_exception": "Positive supportive findings alone do not replace the selected sleep-efficiency failure or create a new effect judgment.",
      "criterion": "Distinguish original information on Positive supportive findings after primary failure, multiplicity and prespecified analyses from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research fixing the hierarchy of primary, secondary and exploratory outcomes"
    },
    {
      "item_id": "N18",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Were randomization, allocation concealment and blinding established?",
      "needed": "Actual procedures for the prospective randomized sham comparison",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were randomization, allocation concealment and blinding established?",
      "application_exception": "The name sham-controlled does not certify successful blinding or absence of bias.",
      "criterion": "Distinguish original information on Actual procedures for the prospective randomized sham comparison from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M08 §8.1–8.2.3; own application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Blinding and allocation plans for device-versus-sham comparisons"
    },
    {
      "item_id": "N19",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What are total 106 and group- and outcome-specific allocation and denominators?",
      "needed": "Overall allocation versus completion, analysis, and night- and endpoint-specific denominators",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are total 106 and group- and outcome-specific allocation and denominators?",
      "application_exception": "106 participants are not divided into invented group allocations, and two-night observations are not added as new participants.",
      "criterion": "Distinguish original information on Overall allocation versus completion, analysis, and night- and endpoint-specific denominators from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Plans distinguishing allocation, people, nights and analysis populations"
    },
    {
      "item_id": "N20",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What are the analysis units for nights, baseline and repeated measurements, and people?",
      "needed": "Nights and visits in the same participants, effects of interest and correlation",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are the analysis units for nights, baseline and repeated measurements, and people?",
      "application_exception": "Two-night findings are not duplicated to increase replication counts or sample size.",
      "criterion": "Distinguish original information on Nights and visits in the same participants, effects of interest and correlation from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying repeated observations and participant-level effects of interest"
    },
    {
      "item_id": "N21",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "How are withdrawal, incomplete assessments, ineligible PSG and missing data handled?",
      "needed": "Missing participants and nights, reasons for missingness and discontinuation, and handling",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are withdrawal, incomplete assessments, ineligible PSG and missing data handled?",
      "application_exception": "Absent material is not declared zero withdrawal, complete two-night participation, ITT or PP.",
      "criterion": "Distinguish original information on Missing participants and nights, reasons for missingness and discontinuation, and handling from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research prespecifying missingness and effects of interest"
    },
    {
      "item_id": "N22",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Are within-group, between-group, adjusted, absolute and change effects distinguished?",
      "needed": "Original between-group contrast versus each group's changes, adjustment and models",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Are within-group, between-group, adjusted, absolute and change effects distinguished?",
      "application_exception": "+0.5 percentage points and -7.9 minutes are not transferred into other effects or denominators or newly analyzed.",
      "criterion": "Distinguish original information on Original between-group contrast versus each group's changes, adjustment and models from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research separating absolute values, changes, relative measures, within-group and between-group contrasts"
    },
    {
      "item_id": "N23",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What are actual device exposure, adherence, deviations and concurrent treatment?",
      "needed": "Actual device operation, wearing, discontinuation and shared conditions",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are actual device exposure, adherence, deviations and concurrent treatment?",
      "application_exception": "Original device exposure is not turned into implementation or sleep and insomnia treatment-replacement instructions.",
      "criterion": "Distinguish original information on Actual device operation, wearing, discontinuation and shared conditions from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research distinguishing actual exposure from assignment effects of interest"
    },
    {
      "item_id": "N24",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What original information describes developer and public support and author interests?",
      "needed": "NIH/NHLBI and Ebb Therapeutics support and author roles",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What original information describes developer and public support and author interests?",
      "application_exception": "Original historical I0 and B2 are not inherited as new review findings, and support information alone does not change judgments on the figures.",
      "criterion": "Distinguish original information on NIH/NHLBI and Ebb Therapeutics support and author roles from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Explicit reporting of support and design and analysis roles"
    },
    {
      "item_id": "N25",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "How are reports, trials, related claims, nights and groups linked within the same family?",
      "needed": "The single Roth2018 reference and trial versus duplicate observations",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are reports, trials, related claims, nights and groups linked within the same family?",
      "application_exception": "One report entry is not certification of a final count of clinical independence.",
      "criterion": "Distinguish original information on The single Roth2018 reference and trial versus duplicate observations from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Records distinguishing reports from study families"
    },
    {
      "item_id": "N26",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What independent confirmation or replication supports selected sleep efficiency?",
      "needed": "Direct independent research on the same absolute sleep-efficiency question",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What independent confirmation or replication supports selected sleep efficiency?",
      "application_exception": "An original single-trial statement is not converted into verification of no current research worldwide, and related sheets are not counted as independent replication.",
      "criterion": "Distinguish original information on Direct independent research on the same absolute sleep-efficiency question from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Separate confirmatory research addressing the same question"
    },
    {
      "item_id": "N27",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Can findings apply to other devices, populations, durations or subgroups?",
      "needed": "Extrapolation beyond the original device and population to general cooling and subgroups",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Can findings apply to other devices, populations, durations or subgroups?",
      "application_exception": "No new claims of null effects for every cooling method, specific-population benefits, or device recommendations and use instructions are created.",
      "criterion": "Distinguish original information on Extrapolation beyond the original device and population to general cooling and subgroups from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying direct applicability"
    },
    {
      "item_id": "N28",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Are PSG findings distinguished from long-term and patient-important insomnia effects?",
      "needed": "Two-night objective measures versus symptoms, everyday function and persistence",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Are PSG findings distinguished from long-term and patient-important insomnia effects?",
      "application_exception": "Positive supportive latency findings are not extended into drug-like efficacy, replacement of treatment or long-term success.",
      "criterion": "Distinguish original information on Two-night objective measures versus symptoms, everyday function and persistence from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.2.4; internally defined extension boundaries; M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research separating PSG from long-term clinical questions"
    },
    {
      "item_id": "N29",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What has actually been obtained and read, and what do URLs and registration links mean?",
      "needed": "Local stored summary versus external abstract, full text and plans",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What has actually been obtained and read, and what do URLs and registration links mean?",
      "application_exception": "Presence of a URL, PMCID or NCT identifier is not presented as external acquisition, reading or a successful link check.",
      "criterion": "Distinguish original information on Local stored summary versus external abstract, full text and plans from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Records separating summary preservation from new acquisition and reading"
    },
    {
      "item_id": "N30",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "How are Korean and English texts, dates, corrections, empty values and historical axes preserved?",
      "needed": "Original language texts, dates, corrections, axes and verification statements",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are Korean and English texts, dates, corrections, empty values and historical axes preserved?",
      "application_exception": "Historical Codex full-text cross-checking is not inherited as passed current clinical review or external reading.",
      "criterion": "Distinguish original information on Original language texts, dates, corrections, axes and verification statements from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Separation of original-value preservation from new evidence and changes"
    },
    {
      "item_id": "N31",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Were adverse-event collection, definitions and scope established?",
      "needed": "Active and passive collection, event definitions, severity and discontinuation",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were adverse-event collection, definitions and scope established?",
      "application_exception": "A statement of similar patterns is not converted into zero harms, equivalent safety or absence of every risk.",
      "criterion": "Distinguish original information on Active and passive collection, event definitions, severity and discontinuation from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying harm collection separately from efficacy"
    },
    {
      "item_id": "N32",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Which group, event and denominator does the headache report refer to?",
      "needed": "Headache groups, people, events, attribution and denominators",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Which group, event and denominator does the headache report refer to?",
      "application_exception": "Headache is not transferred into a confirmed active-group event, and absent counts or incidence rates are not invented.",
      "criterion": "Distinguish original information on Headache groups, people, events, attribution and denominators from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are internally designed; M19 §19.1.2–19.2.4; Internal application; Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Harm research with explicit event, person and exposure units"
    },
    {
      "item_id": "N33",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What are short-term harm-comparison denominators, differences and CIs?",
      "needed": "Group-specific collection populations, event and exposure denominators, and comparisons",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are short-term harm-comparison denominators, differences and CIs?",
      "application_exception": "106 participants and two nights are not automatically used as valid harm denominators or declared equivalence or zero difference.",
      "criterion": "Distinguish original information on Group-specific collection populations, event and exposure denominators, and comparisons from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Plans distinguishing efficacy populations from harm-collection populations"
    },
    {
      "item_id": "N34",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What are harm timing and delayed or long-term findings after two nights?",
      "needed": "Exposure and event timing and post-discontinuation follow-up",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What are harm timing and delayed or long-term findings after two nights?",
      "application_exception": "Similar two-night tolerability is not extended into safety of repeated or long-term use.",
      "criterion": "Distinguish original information on Exposure and event timing and post-discontinuation follow-up from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research prespecifying delayed and long-term harms"
    },
    {
      "item_id": "N35",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What links harms to the device, sham, medical history or medications?",
      "needed": "Temperature, pressure and other exposure, alternative causes and concurrent conditions",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What links harms to the device, sham, medical history or medications?",
      "application_exception": "Pressure, skin injury, causes, prevention or care absent from the summary are not added as new clinical facts.",
      "criterion": "Distinguish original information on Temperature, pressure and other exposure, alternative causes and concurrent conditions from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Harm plans distinguishing exposure of interest from alternative causes"
    },
    {
      "item_id": "N36",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Were harm-related discontinuation and missing PSG established?",
      "needed": "Discontinuation and missingness reasons, completion of harm collection and denominators",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Were harm-related discontinuation and missing PSG established?",
      "application_exception": "Absent material is not converted into zero discontinuation, zero missingness or safety of every completer.",
      "criterion": "Distinguish original information on Discontinuation and missingness reasons, completion of harm collection and denominators from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Plans distinguishing missingness from harm-related discontinuation"
    },
    {
      "item_id": "N37",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "Was independent harm evidence or separate event material obtained?",
      "needed": "Independent harm reports for the same device, population and duration",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: Was independent harm evidence or separate event material obtained?",
      "application_exception": "No separate current entry does not establish absence of every external harm report.",
      "criterion": "Distinguish original information on Independent harm reports for the same device, population and duration from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Independent safety research specifying population, device and exposure"
    },
    {
      "item_id": "N38",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "What is known about safety in vulnerable populations, other diseases and repeated exposure?",
      "needed": "Population- and disease-specific and long-term device-safety scope",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: What is known about safety in vulnerable populations, other diseases and repeated exposure?",
      "application_exception": "No new eligibility, device-setting, cooling, sleep-care or insomnia-treatment instructions are created.",
      "criterion": "Distinguish original information on Population- and disease-specific and long-term device-safety scope from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying population and repeated or long-term safety questions"
    },
    {
      "item_id": "N39",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "How are null PSG efficacy and safety or causal judgments separated?",
      "needed": "Separation of sleep efficiency, harm comparisons, original caution and causality",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are null PSG efficacy and safety or causal judgments separated?",
      "application_exception": "Null sleep efficiency is not converted into safety benefits or harms, or treatment-replacement instructions.",
      "criterion": "Distinguish original information on Separation of sleep efficiency, harm comparisons, original caution and causality from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Plans separating different effects of interest and outcomes"
    },
    {
      "item_id": "N40",
      "question_type": "Absolute sleep efficiency and evidence gaps",
      "question": "How are subsequent material, condition versions, historical candidates and incomplete review linked?",
      "needed": "Identity, units and denominators, outcome hierarchy, reading and change events, and original candidates",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original device and population, endpoints and denominators, and unverified scope for the question: How are subsequent material, condition versions, historical candidates and incomplete review linked?",
      "application_exception": "Historical full-text cross-checking or completed production is not invented as current model or clinical content review or completed publication.",
      "criterion": "Distinguish original information on Identity, units and denominators, outcome hierarchy, reading and change events, and original candidates from unverified details and extensions to other sleep outcomes, harms and long-term findings.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research directly addressing the selected absolute sleep-efficiency gap"
    }
  ]
}