{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2993-s1", "verdict_number": "2993", "title": "Warm bath × sleep efficiency—objective null result and evidence gaps", "view_version": "1.0", "view_created_date": "2026-10-16", "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": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "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": "Core R01 Maeda 2023 is a home crossover trial with 23 adults. Exact ages, sex, insomnia diagnoses, eligibility, recruitment and condition-specific analysis/completion denominators are unverified. Older women with insomnia and nine participants in original R02 Dorsey 1996 bibliography are a separate supporting context; another nine-person mention is unlinked to bibliography. Participants/nights are not added together.", "intervention": "Original R01 distinguishes 40°C shower alone, shower plus about five minutes of bathing and shower plus about 16 minutes. Chest-level immersion, mean long-bath exposure of 16.1 minutes and ending 1.5–2 hours before bed identify study exposure. They are not bathing, sleep or treatment instructions.", "dose": "Temperature, immersion, bathing duration and pre-bed interval are preserved only as original study exposure. Mean long-bath exposure of 16.1 minutes and sleep onset of 16.1±13.9 minutes after the short bath are different values. Individual distributions, temperature maintenance, interval adherence and actual deviations are unverified; no new doses, total times or schedules are calculated.", "comparator": "An active control that already received a 40°C shower. Original categorization as no bath does not mean no heating or no intervention. There was no shower-alone versus no-heating comparison, so results are not transferred into shower efficacy.", "endpoint": "The selected outcome is objective actigraphic sleep efficiency (SE). Shower 78.69%, short bath 80.30%, long bath 82.05% and the null between-condition result are preserved. Exact comparative SE effects, 95% CI, exact P, variance, condition-specific denominators and calculation definition are unverified. SOL of 20.3±14.3, 16.1±13.9 and 12.3±10.1 minutes, P<.05 and the original simple −8.0 minutes are context for a separate endpoint, not SE effects.", "duration": "The original records three conditions in randomized order over approximately three weeks, analyzing one qualifying night per condition. Distinguish single exposure, selected nights and the operational period; this is not extended into daily three-week treatment, long-term effects or insomnia treatment.", "excluded_extensions": [ "Calculating new percentage-point differences from the ordering of SE values or certifying a null result as an effect of 0 or equivalence", "Transferring SOL, perceived sleep quality or sleep-onset grade C into objective SE success or a change to grade D", "Replacing active shower control with no heating/no intervention or establishing shower-alone efficacy", "Expanding one selected night per condition into all nights, complete analysis of all 23 participants or long-term treatment", "Certifying supporting 9-person/unlinked other 9-person mentions or shared sheets as independent SE replication or new participant totals", "Inheriting parent C46/historical checks as a subclaim score or completed current review, or generating bathing/sleep/treatment instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What are the original values for the selected sleep-efficiency claim?", "needed": "Original sleep-efficiency subclaim, grade and note", "role": "Required", "role_reason": "This condition connects Original sleep-efficiency subclaim, grade and note with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Original sleep-efficiency subclaim, grade and note must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: A separate subclaim score, status and assessment axes, and the exact SE definition, conditions, timing and denominators are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The selected original claim is improved sleep efficiency, graded D, with the note that the key crossover trial found no condition difference. The subclaim has no score, status or assessment axes; parent C46 is not substituted.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "A separate subclaim score, status and assessment axes, and the exact SE definition, conditions, timing and denominators are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "A separate subclaim score, status and assessment axes, and the exact SE definition, conditions, timing and denominators are unverified." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What are the core original SE values and comparative result?", "needed": "Original condition-specific objective SE values and comparison", "role": "Required", "role_reason": "This condition connects Original condition-specific objective SE values and comparison with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Original condition-specific objective SE values and comparison must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: SE definition, denominators, model, exact P, comparative effects, CI and missingness are unverified. A null result does not certify an effect of 0 or equivalence. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Shower 78.69%, short bath 80.30%, long bath 82.05% and the null between-condition result are preserved. Their numerical ordering does not establish SE success or justify calculating new percentage-point differences.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "SE definition, denominators, model, exact P, comparative effects, CI and missingness are unverified. A null result does not certify an effect of 0 or equivalence.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SE definition, denominators, model, exact P, comparative effects, CI and missingness are unverified. A null result does not certify an effect of 0 or equivalence." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Is the sleep-onset signal a sleep-efficiency effect?", "needed": "Distinguishing SOL, SE and the original simple mean difference", "role": "Required", "role_reason": "This condition connects Distinguishing SOL, SE and the original simple mean difference with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Distinguishing SOL, SE and the original simple mean difference must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original SE tables, exact comparative effects, CIs and tests are needed. No new effect is calculated from original numbers for another endpoint. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "SOL 20.3±14.3, 16.1±13.9 and 12.3±10.1 minutes, long bath versus shower P<.05 and the original simple −8.0 minutes concern sleep onset. They are not transferred into SE effects, P values or CIs; exact SOL CI and the definition of ± are also unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Original SE tables, exact comparative effects, CIs and tests are needed. No new effect is calculated from original numbers for another endpoint.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original SE tables, exact comparative effects, CIs and tests are needed. No new effect is calculated from original numbers for another endpoint." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Does perceived sleep quality replace objective sleep efficiency?", "needed": "Separate subjective and actigraphic SE outcomes", "role": "Required", "role_reason": "This condition connects Separate subjective and actigraphic SE outcomes with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Separate subjective and actigraphic SE outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: The subjective scale, timing, effect, respective denominators, CI and prospective hierarchy, and SE definition/measurement are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The stored account records improved perceived sleep quality after the long bath but says it does not replace null objective SE. The subjective scale and SE are separate outcomes.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "The subjective scale, timing, effect, respective denominators, CI and prospective hierarchy, and SE definition/measurement are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The subjective scale, timing, effect, respective denominators, CI and prospective hierarchy, and SE definition/measurement are unverified." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Was the actual comparator a warm shower?", "needed": "Distinguishing active shower control from the no-bath label", "role": "Required", "role_reason": "This condition connects Distinguishing active shower control from the no-bath label with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Distinguishing active shower control from the no-bath label must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Protocols, heating, exposure, timing and concurrent behaviors per condition are unverified. An untested shower-versus-no-heating comparison is not converted into shower efficacy. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The actual comparison was 40°C shower alone versus shower followed by a short or long bath. The original no-bath classification already included a warm shower; it was not no heating or no intervention.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Protocols, heating, exposure, timing and concurrent behaviors per condition are unverified. An untested shower-versus-no-heating comparison is not converted into shower efficacy.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocols, heating, exposure, timing and concurrent behaviors per condition are unverified. An untested shower-versus-no-heating comparison is not converted into shower efficacy." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What do temperature, bath duration and bedtime interval describe?", "needed": "Original research exposure and identification", "role": "Required", "role_reason": "This condition connects Original research exposure and identification with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Original research exposure and identification must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Individual actual exposure, temperature maintenance, time definitions, sequence, interval adherence and intervention deviations are unverified. No new total exposure is calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "40°C, approximately 5-minute/16-minute baths, mean long-bath duration 16.1 minutes, ending 1.5–2 hours before bed and chest-level immersion identify the original research exposure. They are not bathing, sleep or treatment instructions.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Individual actual exposure, temperature maintenance, time definitions, sequence, interval adherence and intervention deviations are unverified. No new total exposure is calculated.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual actual exposure, temperature maintenance, time definitions, sequence, interval adherence and intervention deviations are unverified. No new total exposure is calculated." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "How was sleep efficiency actually measured?", "needed": "Actigraphic SE, definition, device and measurement rules", "role": "Required", "role_reason": "This condition connects Actigraphic SE, definition, device and measurement rules with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Actigraphic SE, definition, device and measurement rules must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: The device, algorithm, SE calculation definition, sleep records, measurement rules, valid nights and participant denominators are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "R01 analyzed one qualifying night per condition with actigraphy. The SE algorithm, bedtime/wake-time references, missing records and comparison with PSG are not established by this summary.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "The device, algorithm, SE calculation definition, sleep records, measurement rules, valid nights and participant denominators are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The device, algorithm, SE calculation definition, sleep records, measurement rules, valid nights and participant denominators are unverified." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What are the analysis denominators for the selected night?", "needed": "23 adults, operational period and condition-specific selected nights", "role": "Required", "role_reason": "This condition connects 23 adults, operational period and condition-specific selected nights with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for 23 adults, operational period and condition-specific selected nights must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Eligibility, night selection/exclusion, valid participants/nights, prospective plans, missing-data handling and condition-specific analysis denominators are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "23 adults experienced three conditions in randomized order over approximately 3 weeks, with one qualifying night analyzed per condition. This is not expanded into all nights or complete analysis of everyone, and total nights/participants are not newly calculated.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Eligibility, night selection/exclusion, valid participants/nights, prospective plans, missing-data handling and condition-specific analysis denominators are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility, night selection/exclusion, valid participants/nights, prospective plans, missing-data handling and condition-specific analysis denominators are unverified." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are crossover order and period effects known?", "needed": "Randomized order, washout, carryover and within-person analysis", "role": "Required", "role_reason": "This condition connects Randomized order, washout, carryover and within-person analysis with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Randomized order, washout, carryover and within-person analysis must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Sequence generation, concealment, intervals between conditions, period/carryover effects, within-person repeated-measures models and attrition are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "R01 Maeda2023 was a randomized-order home crossover trial. The design label alone does not verify allocation concealment, sufficient washout or control of period/carryover effects.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Sequence generation, concealment, intervals between conditions, period/carryover effects, within-person repeated-measures models and attrition are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sequence generation, concealment, intervals between conditions, period/carryover effects, within-person repeated-measures models and attrition are unverified." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Was SE a prospective primary endpoint?", "needed": "Prospective endpoint hierarchy and analysis plan", "role": "Required", "role_reason": "This condition connects Prospective endpoint hierarchy and analysis plan with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Prospective endpoint hierarchy and analysis plan must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Dated registration, protocol, SAP, SE hierarchy, night selection, multiple testing and change history are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The stored account records an unverified prospective primary endpoint. Listing SOL, SE and perceived sleep quality together does not establish that all were prospective primary outcomes or that prospective success/failure rules were verified.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Dated registration, protocol, SAP, SE hierarchy, night selection, multiple testing and change history are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Dated registration, protocol, SAP, SE hierarchy, night selection, multiple testing and change history are unverified." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are exact comparative SE effects and confidence intervals available?", "needed": "SE estimates, variance, denominators and testing", "role": "Required", "role_reason": "This condition connects SE estimates, variance, denominators and testing with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for SE estimates, variance, denominators and testing must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original comparative SE statistical tables, models, denominators, CIs, multiple testing and relevance thresholds are needed. No hypothetical examples or new effect/CI calculations are made. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original SE values for the three conditions and the null-result wording are preserved. Exact comparative SE estimates, 95% CI, exact P, variance and denominators are unverified, separately from the SOL CI gap.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Original comparative SE statistical tables, models, denominators, CIs, multiple testing and relevance thresholds are needed. No hypothetical examples or new effect/CI calculations are made.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original comparative SE statistical tables, models, denominators, CIs, multiple testing and relevance thresholds are needed. No hypothetical examples or new effect/CI calculations are made." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Does the supporting Dorsey report provide the same SE outcome?", "needed": "Citation-only support in older women with insomnia", "role": "Required", "role_reason": "This condition connects Citation-only support in older women with insomnia with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Citation-only support in older women with insomnia must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Exact SE, SOL, conditions, timing, denominators, effects, CIs and study relationships are unverified. The external abstract/full text were unread in this work. This records needed materials; no new research was executed.", "current_reports": [ "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "R02 Dorsey1996 is a supporting citation describing older women with insomnia, 9 participants and a historical abstract check. Without a separate evidence row or individual SE values, effects or CIs, it is not treated as core SE replication or verified positive SE.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact SE, SOL, conditions, timing, denominators, effects, CIs and study relationships are unverified. The external abstract/full text were unread in this work.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact SE, SOL, conditions, timing, denominators, effects, CIs and study relationships are unverified. The external abstract/full text were unread in this work." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are both older experiments linked to bibliography?", "needed": "Supporting-trial mentions and population/timing/bibliographic correspondence", "role": "Required", "role_reason": "This condition connects Supporting-trial mentions and population/timing/bibliographic correspondence with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Supporting-trial mentions and population/timing/bibliographic correspondence must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Exact bibliography, population, timing, outcomes and direct SE relevance of each supporting experiment are unverified. All features are not assigned to Dorsey and no new report is created. This records needed materials; no new research was executed.", "current_reports": [ "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The stored account mentions two older crossover experiments with 9 participants each and differences including older women with insomnia, healthy women and 30 minutes before bed. Current citations are Maeda and Dorsey; a separate citation for the other older experiment is unlinked.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact bibliography, population, timing, outcomes and direct SE relevance of each supporting experiment are unverified. All features are not assigned to Dorsey and no new report is created.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact bibliography, population, timing, outcomes and direct SE relevance of each supporting experiment are unverified. All features are not assigned to Dorsey and no new report is created." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are the core adult and older insomnia samples equivalent?", "needed": "Selected populations, baseline sleep and generalization", "role": "Required", "role_reason": "This condition connects Selected populations, baseline sleep and generalization with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Selected populations, baseline sleep and generalization must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Population, age, sex, baseline sleep/disease, medication, screening, exclusions and condition-specific denominators per report are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The core involved 23 adults; older women with insomnia in R02 are a different supporting context. Eligibility, baseline sleep, medication and heating exposure are not established as identical or generalized into SE findings for all insomnia patients.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Population, age, sex, baseline sleep/disease, medication, screening, exclusions and condition-specific denominators per report are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Population, age, sex, baseline sleep/disease, medication, screening, exclusions and condition-specific denominators per report are unverified." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Do single conditions over approximately 3 weeks establish sustained treatment effects?", "needed": "Single exposure, operational period and long-term SE", "role": "Required", "role_reason": "This condition connects Single exposure, operational period and long-term SE with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Single exposure, operational period and long-term SE must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct evidence for repeated use, post-intervention SE, long-term clinical sleep outcomes, exposure, denominators and comparators is not linked. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The core comparison involved crossover experience of single pre-bed conditions over approximately 3 weeks. This is not converted into daily treatment for 3 weeks, long-term SE improvement, insomnia treatment or medication replacement.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Direct evidence for repeated use, post-intervention SE, long-term clinical sleep outcomes, exposure, denominators and comparators is not linked.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct evidence for repeated use, post-intervention SE, long-term clinical sleep outcomes, exposure, denominators and comparators is not linked." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What is the interpretation boundary of the null SE result?", "needed": "Null result, effect of 0, equivalence and other sleep effects", "role": "Required", "role_reason": "This condition connects Null result, effect of 0, equivalence and other sleep effects with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Null result, effect of 0, equivalence and other sleep effects must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: SE relevance thresholds, exact effects/CIs and direct evidence for other sleep endpoints/times are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The null between-condition objective SE result is retained as the original finding. A null result does not certify an effect of 0, equivalence, absence of all sleep effects, safety or subjective restorative-sleep success. Original selected grade D is not reassessed.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "SE relevance thresholds, exact effects/CIs and direct evidence for other sleep endpoints/times are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SE relevance thresholds, exact effects/CIs and direct evidence for other sleep endpoints/times are unverified." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are shared reports distinguished from independent replication?", "needed": "Parent, two subclaim sheets, reports and population relationships", "role": "Required", "role_reason": "This condition connects Parent, two subclaim sheets, reports and population relationships with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Parent, two subclaim sheets, reports and population relationships must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Report-specific cohorts, periods, analysis populations, shared relationships and exact independent SE replication are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Parent 2993 and the two subclaim sheets share the same preserved report context. Reports, sheets, selected nights and repeated measurements are not summed into new independent trials/participants; unique trial/participant totals are unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Report-specific cohorts, periods, analysis populations, shared relationships and exact independent SE replication are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific cohorts, periods, analysis populations, shared relationships and exact independent SE replication are unverified." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What was actually read?", "needed": "Complete stored summary and unread external material", "role": "Required", "role_reason": "This condition connects Complete stored summary and unread external material with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Complete stored summary and unread external material must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: External originals, supplements, registration, plans, actual reading records and content review remain outstanding. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The complete parent stored summary was read and preserved in full. External abstracts, full texts, registration, protocols and SAPs are unread; URLs/identifiers alone do not upgrade public availability, access, reading or condition fulfillment.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "External originals, supplements, registration, plans, actual reading records and content review remain outstanding.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External originals, supplements, registration, plans, actual reading records and content review remain outstanding." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Were original Korean/English and historical verification narratives preserved?", "needed": "Original languages, subclaim note and historical verification scope", "role": "Required", "role_reason": "This condition connects Original languages, subclaim note and historical verification scope with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Original languages, subclaim note and historical verification scope must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Details of the original external checks and current content, translation and claim-boundary review remain incomplete. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original Korean/English, subclaims/notes and historical original-table, PubMed, comparator and citation-check narratives are preserved unchanged internally. They do not become current external reading, completed content review or independent clinical validation.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Details of the original external checks and current content, translation and claim-boundary review remain incomplete.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Details of the original external checks and current content, translation and claim-boundary review remain incomplete." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are subclaim D and parent score/axes distinguished?", "needed": "Original subclaim values, parent C46, axes and safety", "role": "Required", "role_reason": "This condition connects Original subclaim values, parent C46, axes and safety with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Original subclaim values, parent C46, axes and safety must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: A separate subclaim score, status and axes are absent from the source. No new score, grade, axes, efficacy or independence certification is created. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Subclaim D, its note and the absence of a separate score, status or axes are retained. Parent C46, Unknown, B/S/R1/I1/EX/B2/CX, four false flags, an empty override and the other sleep-onset subclaim C concern the parent and separate outcome; they do not supply an SE score.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "A separate subclaim score, status and axes are absent from the source. No new score, grade, axes, efficacy or independence certification is created.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "A separate subclaim score, status and axes are absent from the source. No new score, grade, axes, efficacy or independence certification is created." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are evidence cut-off, corrections and production dates distinguished?", "needed": "Original date and empty correction/deliberation records", "role": "Required", "role_reason": "This condition connects Original date and empty correction/deliberation records with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Original date and empty correction/deliberation records must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Latest corrections, follow-up materials, complete prior history and current content review remain outstanding. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Original evidence cut-off 2026-09-07, an empty correction array and an empty deliberation string are retained. The unrecorded material-review date stays unrecorded; the production date is not used as a new clinical-review date or certification of no external corrections.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Latest corrections, follow-up materials, complete prior history and current content review remain outstanding.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Latest corrections, follow-up materials, complete prior history and current content review remain outstanding." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are bibliographic/registration identities different from actual access?", "needed": "Original PMID, DOI, PMCID and registration presence/absence", "role": "Required", "role_reason": "This condition connects Original PMID, DOI, PMCID and registration presence/absence with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Original PMID, DOI, PMCID and registration presence/absence must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Identifiers/URLs do not establish reading, prospective status or accessibility. No new full-text/registration URLs are inferred. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "R01 PMID37684642, PMCID PMC10486043, DOI10.1186/s40101-023-00337-0, and R02 PMID8736588, DOI10.1177/089198879600900203 are preserved. Registration identifiers are unrecorded; only the two original PubMed URLs are linked.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Identifiers/URLs do not establish reading, prospective status or accessibility. No new full-text/registration URLs are inferred.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Identifiers/URLs do not establish reading, prospective status or accessibility. No new full-text/registration URLs are inferred." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are funding, employee authors, product support and analysis/reporting involvement distinguished?", "needed": "Report-specific funding, support, affiliation and roles", "role": "Required", "role_reason": "This condition connects Report-specific funding, support, affiliation and roles with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Report-specific funding, support, affiliation and roles must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original funding roles, COI, product/equipment support, employee affiliations and analysis/publication roles per report are unread. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "R01 records funding not applicable alongside 2 authors affiliated with Noritz research and development. The funding wording is not converted into absence of employee involvement; product support, analysis/reporting roles and R02 support remain separately unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Original funding roles, COI, product/equipment support, employee affiliations and analysis/publication roles per report are unread.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding roles, COI, product/equipment support, employee affiliations and analysis/publication roles per report are unread." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are details of allocation, measurement and selective reporting available?", "needed": "Randomized crossover, masking, denominators and plans", "role": "Required", "role_reason": "This condition connects Randomized crossover, masking, denominators and plans with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Randomized crossover, masking, denominators and plans must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Allocation concealment, assessor/analyst masking, devices, algorithms, missingness, prospective plans and change history are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Home crossover, selected nights, active shower control and SOL, SE and subjective outcomes are distinguished. Actigraphy alone does not verify analyst masking or control of expectations, missingness or selective reporting.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Allocation concealment, assessor/analyst masking, devices, algorithms, missingness, prospective plans and change history are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation concealment, assessor/analyst masking, devices, algorithms, missingness, prospective plans and change history are unverified." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are actual exposure, adherence and concurrent conditions known?", "needed": "Original research exposure, cointerventions and deviations", "role": "Required", "role_reason": "This condition connects Original research exposure, cointerventions and deviations with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Original research exposure, cointerventions and deviations must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Report-specific exposure, adherence, deviations, sleep schedules, environment, caffeine, alcohol, medication, concurrent care and denominators are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Temperature, duration and shower-followed-by-bath conditions identify research exposure. Actual exposure, selected nights, other bedtime behaviors, medication and adherence are not established as identical across conditions.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Report-specific exposure, adherence, deviations, sleep schedules, environment, caffeine, alcohol, medication, concurrent care and denominators are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific exposure, adherence, deviations, sleep schedules, environment, caffeine, alcohol, medication, concurrent care and denominators are unverified." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are original safety wording and actual adverse-event rates distinguished?", "needed": "Adverse-event collection, exposure, comparator and denominators", "role": "Supplementary", "role_reason": "This condition connects Adverse-event collection, exposure, comparator and denominators with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Adverse-event collection, exposure, comparator and denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Report-specific event definitions, collection, exposure, denominators, deviations, comparators, severity and links to original reports are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "Parent safety is Unknown, with systematic adverse-event denominators/rates unverified. Burns, dizziness and falls are original generalization limitations, not actual event rates or harms newly verified in this work.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Report-specific event definitions, collection, exposure, denominators, deviations, comparators, severity and links to original reports are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific event definitions, collection, exposure, denominators, deviations, comparators, severity and links to original reports are unverified." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Can this extend to long-term/rare harms and clinical outcomes?", "needed": "Selected adults, short observation and long-term/rare harms", "role": "Supplementary", "role_reason": "This condition connects Selected adults, short observation and long-term/rare harms with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Selected adults, short observation and long-term/rare harms must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Long-term follow-up, population, exposure, harm surveillance, endpoint-specific denominators, CIs and clinical sleep outcomes are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "The stored account says risks cannot be assumed identical beyond selected adults and the research temperature. Short SE findings are not expanded into long-term SE, insomnia treatment, absence of rare harms or safety certification.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Long-term follow-up, population, exposure, harm surveillance, endpoint-specific denominators, CIs and clinical sleep outcomes are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term follow-up, population, exposure, harm surveillance, endpoint-specific denominators, CIs and clinical sleep outcomes are unverified." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Which materials would trigger an update?", "needed": "Original material, conditions, observations and change events", "role": "Required", "role_reason": "This condition connects Original material, conditions, observations and change events with objective sleep efficiency, active shower control, original condition-specific values and the null result, sleep-onset/subjective outcomes, crossover order, selected nights, denominators and harms.", "application_exception": "Preserve original numbers, ±, P values and study exposure only. Distinguish null between-condition SE from SOL/subjective outcomes, active shower control from no heating, one selected night from the operational period, mean exposure of 16.1 minutes from short-bath mean SOL of 16.1 minutes, and the core report from supporting bibliography/unlinked mentions. A null result does not certify an effect of 0, equivalence or absence of all sleep effects. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, bathing/sleep methods, treatment or procedure instructions are created.", "criterion": "Material for Original material, conditions, observations and change events must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Complete prior texts/materials, condition versions, separate application records and change history must be retained. No new research, calculations, grades, independence certification or bathing/sleep instructions were executed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread", "observation": "This is a reader projection of existing sleep-efficiency material. Relevant observations may be updated when original SE tables, protocols, registration, report mapping, exact effects/denominators, support/harms material and content review become available.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Complete prior texts/materials, condition versions, separate application records and change history must be retained. No new research, calculations, grades, independence certification or bathing/sleep instructions were executed.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete prior texts/materials, condition versions, separate application records and change history must be retained. No new research, calculations, grades, independence certification or bathing/sleep instructions were executed." } ], "reports": [ { "report_id": "R01", "title": "Maeda T et al. 2023", "url": "https://pubmed.ncbi.nlm.nih.gov/37684642/", "report_type": "Randomized-order home crossover trial", "existence": "Bibliography is present in the original stored citation list. External public availability and access status are unverified in this work.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread without access attempts", "study_family": "F01", "independent_replication": "The parent and two subclaim sheets share the same stored report context. Core 23 participants, supporting nine, another unlinked nine and selected nights are not counted as new unique trials, participants or independent replications. Confirmed totals are unrecorded and review of existing content remains incomplete.", "observed_result": "Actigraphic SE 78.69%, 80.30% and 82.05%: null between-condition result; SOL and perceived sleep quality are separate", "result_level": "Core evidence row for the selected sleep-efficiency question. This was a randomized-order home crossover in 23 adults with one analyzed night per condition; exact SE effects, CIs, denominators and prospective hierarchy are unverified. The null result is not extended to equivalence or absence of other sleep effects.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Original PubMed URL, PMID 37684642, PMCID PMC10486043 and DOI 10.1186/s40101-023-00337-0 are preserved. The original evidence row lacks a registration key and its citation lacks a registration number. Identifiers/URLs alone do not certify acquisition, reading, prior plans or condition fulfillment; new full-text/registration URLs are not inferred." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original PubMed URL, PMID 37684642, PMCID PMC10486043 and DOI 10.1186/s40101-023-00337-0 are preserved. The original evidence row lacks a registration key and its citation lacks a registration number. Identifiers/URLs alone do not certify acquisition, reading, prior plans or condition fulfillment; new full-text/registration URLs are not inferred." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original PubMed URL, PMID 37684642, PMCID PMC10486043 and DOI 10.1186/s40101-023-00337-0 are preserved. The original evidence row lacks a registration key and its citation lacks a registration number. Identifiers/URLs alone do not certify acquisition, reading, prior plans or condition fulfillment; new full-text/registration URLs are not inferred." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original PubMed URL, PMID 37684642, PMCID PMC10486043 and DOI 10.1186/s40101-023-00337-0 are preserved. The original evidence row lacks a registration key and its citation lacks a registration number. Identifiers/URLs alone do not certify acquisition, reading, prior plans or condition fulfillment; new full-text/registration URLs are not inferred." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original PubMed URL, PMID 37684642, PMCID PMC10486043 and DOI 10.1186/s40101-023-00337-0 are preserved. The original evidence row lacks a registration key and its citation lacks a registration number. Identifiers/URLs alone do not certify acquisition, reading, prior plans or condition fulfillment; new full-text/registration URLs are not inferred." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/37684642/" } ] }, { "report_id": "R02", "title": "Dorsey CM et al. 1996", "url": "https://pubmed.ncbi.nlm.nih.gov/8736588/", "report_type": "Supporting citation-only bibliography; not the core evidence row", "existence": "Bibliography is present in the original stored citation list. External public availability and access status are unverified in this work.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread without access attempts", "study_family": "F02", "independent_replication": "The parent and two subclaim sheets share the same stored report context. Core 23 participants, supporting nine, another unlinked nine and selected nights are not counted as new unique trials, participants or independent replications. Confirmed totals are unrecorded and review of existing content remains incomplete.", "observed_result": "Citation record of a supporting direction in older women with insomnia, 9 participants and a historical abstract check; individual SE values, effects and CIs unverified", "result_level": "Supporting bibliography present only in the original citations, without a separate evidence row or individual SE result. It is not treated as core SE replication or verified positive SE; the external abstract, full text and plans were unread in this work.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Original PubMed URL, PMID 8736588, DOI 10.1177/089198879600900203 and unrecorded PMCID/registration number are preserved. Historical abstract checking is not inherited as current reading; core exposure or details of another unlinked report are not filled from this bibliography." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original PubMed URL, PMID 8736588, DOI 10.1177/089198879600900203 and unrecorded PMCID/registration number are preserved. Historical abstract checking is not inherited as current reading; core exposure or details of another unlinked report are not filled from this bibliography." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original PubMed URL, PMID 8736588, DOI 10.1177/089198879600900203 and unrecorded PMCID/registration number are preserved. Historical abstract checking is not inherited as current reading; core exposure or details of another unlinked report are not filled from this bibliography." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original PubMed URL, PMID 8736588, DOI 10.1177/089198879600900203 and unrecorded PMCID/registration number are preserved. Historical abstract checking is not inherited as current reading; core exposure or details of another unlinked report are not filled from this bibliography." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original PubMed URL, PMID 8736588, DOI 10.1177/089198879600900203 and unrecorded PMCID/registration number are preserved. Historical abstract checking is not inherited as current reading; core exposure or details of another unlinked report are not filled from this bibliography." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/8736588/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Some information is present in the stored source, with detailed original materials still unverified; this does not mean review passed or clinical efficacy certified", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Awaiting user review", "Met": "Use only within the relevant condition's scope after user review; no automatic display in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Core R01 Maeda 2023 crossover trial and supporting R02 Dorsey 1996 bibliography differ in population, exposure, timing and directness. The parent and two subclaim sheets share the same stored context. The two older nine-person experiments mentioned in the text are not fully mapped one-to-one to the two current citations. Core 23, supporting nine, another unlinked nine, selected nights and two sheets are not added as unique trials, participants or independent replications; confirmed totals are unrecorded." }, "history": [ { "date": "2026-10-16", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-16" }