{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2982-s0",
  "verdict_number": "2982",
  "title": "Forehead-cooling device × Absolute latency to persistent sleep: Null co-primary findings and separate supportive measures",
  "view_version": "1.0",
  "view_created_date": "2026-10-15",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-09-07",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "population": "106 adults with diagnosed insomnia were randomized; detailed analyses and withdrawals by group, night and endpoint are unverified.",
    "intervention": "A frontal thermal-therapy device regulating forehead temperature at 14–16°C, distinguished from ordinary cold packs",
    "dose": "Original study-device identification: 14–16°C for two nights. This is not an instruction on duration of use, settings, cooling or sleep care.",
    "comparator": "Sham device; actual temperature and operation, blinding and concurrent exposures are not verified in detail.",
    "endpoint": "Co-primary PSG result for absolute latency to persistent sleep, distinguished from sleep efficiency, relative LPS and supportive latency to stages 1 and 2",
    "duration": "Two-night assessment; baseline and adaptation nights, night-specific analyses, persistence after exposure and long-term follow-up are not verified in detail.",
    "excluded_extensions": [
      "Transferring positive relative or stage-specific supportive findings into co-primary success for absolute LPS",
      "Rejudging a null between-group finding as an exactly zero effect, equivalence or noninferiority",
      "Converting sleep-efficiency percentage points into sleep-latency minutes, subjective outcomes or long-term clinical effects",
      "Adding the same people, nights, endpoints, groups, references or related sheets as new independent trials or participants",
      "New calculations, hypothetical quantities, effects, CIs, grades or independence certification, or instructions for devices, forehead cooling, sleep care or replacement of treatment"
    ]
  },
  "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The selected claim is improved absolute latency to persistent sleep, with subclaim grade D and a note that P=.092 was null. Subclaim score, status and axes are absent and are retained separately from parent D with 28 points and its axes.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original material records randomization of 106 adults with diagnosed insomnia to active or sham devices. Age range, diagnostic details, comorbidities, sleep medication and other exposure details are not established in the stored summary.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "Original eligibility and exclusion criteria, diagnostic criteria, baseline characteristics, medication and concurrent treatment, and adherence. Application is not extended to every sleep problem.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original eligibility and exclusion criteria, diagnostic criteria, baseline characteristics, medication and concurrent treatment, and adherence. Application is not extended to every sleep problem."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original intervention was a frontal thermal-therapy device regulating forehead temperature at 14–16°C. The original statement that it is not equivalent to an ordinary cold pack is retained. Temperature identifies the study device and is not an implementation instruction.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original design was prospective, randomized and sham-controlled, and the classification information indicates sham intervention. Actual sham temperature, operation, sensation, successful blinding and concurrent-treatment details are not established in the summary.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original material records two-night assessment. Baseline measurement nights, adaptation nights, night-specific findings, averaging and follow-up after exposure are not verified in detail. Two nights are not added as separate trials or participant counts.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original co-primary endpoints were absolute latency to persistent sleep and absolute sleep efficiency. PSG rules for persistent sleep, timing definitions, scoring, night-specific aggregation and analysis timing are not established from the stored summary alone.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original material distinguishes null co-primary absolute LPS from favorable relative latency to persistent sleep in supportive analyses. Absolute values and relative changes are not combined as the same estimand or success criterion.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The between-group difference in absolute latency to persistent sleep was -7.9 minutes (95% CI -18.4 to 2.6), P=.092, and the original verdict was null. This is not rejudged as positive, an exactly zero effect, equivalence or noninferiority.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The absolute sleep-efficiency difference was +0.5 percentage points (95% CI -3.4 to 4.5), P=.759. This is another endpoint in the same 106-person, two-night trial, not the absolute-LPS effect or separate independent replication.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "Sleep-efficiency calculations, denominators, models, co-primary specifications and endpoint-specific analysis material. Percentage points are not converted into minutes or event effects.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Sleep-efficiency calculations, denominators, models, co-primary specifications and endpoint-specific analysis material. Percentage points are not converted into minutes or event effects."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original material states that both prespecified co-primary PSG endpoints were null and favorable supportive findings do not replace these failures. Prespecification is retained as an original statement, not certification of new reading of the registration or SAP.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "Registration, protocol and SAP versions and dates, co-primary success rules, multiplicity plans and amendment history. No new trial-success or grade judgment.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Registration, protocol and SAP versions and dates, co-primary success rules, multiplicity plans and amendment history. No new trial-success or grade judgment."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The stored summary provides the absolute-LPS between-group difference of -7.9 minutes, but not detailed baseline and final group means or variance, night-specific values or changes. Group values are not reverse-calculated from the between-group difference.",
      "condition_status": "Unverified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original counterview records a favorable direction for relative latency to persistent sleep. Individual quantitative effects, CIs, P values and models are absent from the summary; absolute-LPS P=.092 is not copied as the value of this supportive finding.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original statement describes favorable latencies to stages 1 and 2 in supportive analyses. These are not the same findings as absolute latency to persistent sleep or sleep efficiency. Individual stage effects, CIs and P values are not newly filled in.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original material explains that foregrounding favorable supportive measures can obscure the core failures. The number of all supportive endpoints, testing plans and selective reporting are not newly established from this summary.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original material records randomization of 106 adults and assessment over two nights. Group-specific allocation, analysis and completion, valid PSG data by endpoint, withdrawals and missingness are not established in the stored summary.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original reader answer gives between-group differences, while supportive relative-latency change is separate. Detailed natural change in each group, sham responses, models and adjustment are absent; within-group improvement is not transferred into an additional active-treatment effect.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original material records broadly similar adverse-event patterns with the sham device over two nights and reports of headache and other events. Group-specific event counts, severity, attribution, discontinuation and exposure denominators are not verified in detail. Similar patterns are not converted into absence of harms or equivalence.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original material explains that separate trials are needed for long-term efficacy and safety. Some supportive sleep-latency signals are not extended into long-term insomnia improvement, daytime function, replacement of treatment or long-term safety.",
      "condition_status": "Unverified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The complete parent summary was read for production and preserved in its original form. Summary reading in material entries refers to the stored summary; external abstract, full text, registration, protocol and SAP were not read. The presence of a URL or PMCID is not promoted into external reading.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "NCT01966211 appears in the original evidence and citation. The identifier is retained; there has been no new reading or verification of registration content, versions, timing, results disclosure or agreement with plans. An official registration URL is not guessed.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "Specific protocol and SAP URLs, original text, versions and dates were not newly acquired or read. Parent statements about prespecified endpoints and historical cross-checking are retained as history and are not described as new content review.",
      "condition_status": "Unverified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "Original funding records list NIH and NHLBI support, Ebb Therapeutics device and study involvement, and a company founder and executive as author. Public support is distinguished from company device support, study involvement and employee or executive authors. Separate amounts of company funding and detailed analysis and design roles are not established.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original null absolute-LPS P=.092, favorable supportive signals and unverified external details are different states.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "Parent verdict 2982 and the latency and sleep-efficiency sheets share the same Roth2018 report and 106-person, two-night trial context. The same people, groups, nights, endpoints, supportive analyses, references and related sheets are not added as new independent trials or participants. One current report link is not a certified count of unique trials or participants.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "Original parent replication and independence axes R1/I0 are retained. Reuse of the current reference and related sheets is not certified as new independent efficacy or harm replication.",
      "condition_status": "Unverified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The selected subclaim grade and note are retained in their original form, and absent score, status and axes remain unrecorded. Parent D with 28 points, safety and axes are parent context. No new score, grade or official RoB2 or GRADE certification is produced.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The complete parent Korean and English texts, classification information, evidence and citations, and selected subclaim wording, grade and note are preserved in the complete stored summary. This is not a new comparison with the English original paper or another verdict.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The original reference date 2026-09-07, empty correction array and empty deliberation string are retained. Cross-checking in the historical verdict-decision record is original history, distinct from current production dates, condition-application times or completed content review.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "The null two-night absolute-LPS co-primary finding is retained together with supportive-measure signals. Confirmation of the question requires direct active-versus-sham material on prespecified absolute LPS and longer follow-up.",
      "condition_status": "Unverified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.",
      "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread",
      "observation": "This is a record of applied conditions based on a stored summary. Existing content and claim-boundary review is incomplete; candidate review-pending and production-eligibility indicators are retained as history. The original review status is recorded unchanged.",
      "condition_status": "Partly verified",
      "status_reason": "An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.",
      "missingness": "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.",
      "uncertainty": "External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "title": "Roth T, Mayleben D, Feldman N, et al. A novel forehead temperature-regulating device for insomnia: a randomized clinical trial. Sleep. 2018;41(5):zsy045. PMID: 29648642. PMCID: PMC5946849. DOI: 10.1093/sleep/zsy045. NCT01966211.",
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}