{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2981-s1", "verdict_number": "2981", "title": "Phase-locked closed-loop acoustic stimulation × Increased whole-night deep sleep", "view_version": "1.0", "view_created_date": "2026-10-15", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "13 healthy adults aged 60–84 in a within-person crossover sleep-laboratory trial, with one night each under active STIM and sham conditions. Detailed eligibility, baseline cognition and sleep, memory and EEG analysis denominators, withdrawals and missingness are unverified.", "intervention": "The study identity of brief closed-loop pink-noise pulses timed to the rising phase of EEG slow waves is retained. It is not converted into efficacy or setting instructions for ordinary continuous overnight playback, speakers or apps.", "dose": "One night per condition. Local ON-window aggregation is distinguished from whole-night or total NREM aggregation. Exact windows, counts, exposure and weighting methods are unverified; no new conversions or settings are produced.", "comparator": "Within-person STIM-versus-sham crossover. Actual sham conditions, contact and expectations, blinding, period models, and concurrent sleep, medication and lifestyle conditions are unverified.", "endpoint": "Nonsignificant whole-night NREM SWA of 121.7 versus 124.4 μV²/Hz, P=.80, and subclaim grade D are retained. An approximately 8% ON-window increase, P=.002, and recall change of 9.2 versus 3.1 words, P=.02, concern other scopes and endpoints. SWA power is not converted into N3 minutes, proportions or total sleep time. Exact whole-night effects, CIs and stage-specific times are unverified.", "duration": "One night per condition. Whole-night sleep effects under long-term or repeated exposure, or in other populations, devices and indications, are not linked. Subsequent multiple-night studies mentioned in the original Korean text have no linked specific reference and are not created as new reports.", "excluded_extensions": [ "Converting overnight recall improvement of 9.2 versus 3.1 words into final absolute next-day scores, new between-group differences or CIs, or individual response rates", "Combining whole-night NREM SWA of 121.7 versus 124.4 μV²/Hz and the approximately 8% ON-window signal as the same scope or unit", "Converting SWA power into N3 minutes, deep-sleep proportions or total sleep time", "Certifying P=.80 as an exactly zero effect, equivalence, or null findings for every sleep stage or other endpoint", "Extending the memory–SWA association into proof of causation or mediation, or therapeutic effects on durable cognition or everyday function", "Adding the same 13 participants, active and sham conditions, nights, words, stimuli, EEG windows, references or related sheets as independent trials or participants", "Creating a new report or independent replication from a subsequent multiple-night study mentioned without a linked specific reference", "Transferring research EEG phase-locked closed-loop stimulation findings to ordinary continuous sound, consumer apps or speakers, or other populations", "Inheriting parent values, axes and historical full-text cross-checks as subclaim scores or new content review or external reading", "New calculations, hypothetical numbers, effects, CIs, grades or independence certification, device, acoustic or stimulation settings, or instructions for sleep or cognitive training or replacement of treatment" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected whole-night question and original grade", "needed": "Selected wording, note and grade versus local-window and memory questions", "role": "Required", "role_reason": "This item distinguishes selected wording, note and grade versus local-window and memory questions to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for selected wording, note and grade versus local-window and memory questions must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Update the record while distinguishing the whole night from stimulation windows and memory questions. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected existing record is “Increased whole-night deep sleep”, with grade D and a note that whole-night NREM SWA was null, P=.80. Subclaim score, status and axes are absent; parent C54 and memory grade C are not used to fill them.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. Separate subclaim score, status and axes are absent from the original material. Review of existing content is incomplete.", "missingness": "Separate subclaim score, status and axes are absent from the original material.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Selected original version and comments" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Definitions of SWA and deep-sleep stages and time", "needed": "Whole-night NREM power, N3 and stages, proportions and time", "role": "Required", "role_reason": "This item distinguishes whole-night NREM power, N3 and stages, proportions and time to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for whole-night NREM power, N3 and stages, proportions and time must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material separating physiological power from stages and time. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original quantitative whole-night measure is NREM slow-wave activity in μV²/Hz. It is not recast as the same unit or finding as whole-night N3 minutes, deep-sleep proportions or total sleep time.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. N3 and stage definitions, time and proportions, total sleep denominators and correspondence with SWA are unverified. Review of existing content is incomplete.", "missingness": "N3 and stage definitions, time and proportions, total sleep denominators and correspondence with SWA are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 original whole-night SWA, sleep-stage and time tables, and measurement definitions" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Whole-night NREM 121.7 versus 124.4 and P", "needed": "Original whole-night values, comparisons and exact estimands", "role": "Required", "role_reason": "This item distinguishes original whole-night values, comparisons and exact estimands to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for original whole-night values, comparisons and exact estimands must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptations are internally designed. M08 §8.2.2 and M15 §15.3.1; internal application. M15 §15.3.1–15.3.3; internal application. M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing nonsignificance from estimation uncertainty. No new difference or CI is calculated. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Whole-night NREM SWA of 121.7 versus 124.4 μV²/Hz, P=.80, is nonsignificant in the original statement. It is not extended into an exactly zero effect, equivalence or no change in every sleep stage.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. Exact within-person effects and CIs, models, total NREM denominators and variance are unverified. Review of existing content is incomplete.", "missingness": "Exact within-person effects and CIs, models, total NREM denominators and variance are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 original total NREM tables, models, denominators and CIs" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Approximately 8% during ON windows versus the whole night", "needed": "Short windows, whole-night averages, denominators and units", "role": "Required", "role_reason": "This item distinguishes short windows, whole-night averages, denominators and units to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for short windows, whole-night averages, denominators and units must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material disclosing separate specifications for local windows and the whole night. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The approximately 8% increase during stimulation ON windows, P=.002, is a physiological signal during short stimulation windows. It is not transferred into a whole-night NREM effect, N3 time or proportion, or increased whole-night deep sleep.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. ON/OFF window definitions, exposure lengths and repetitions, window and whole-night weighting, and exact effects and CIs are unverified. Review of existing content is incomplete.", "missingness": "ON/OFF window definitions, exposure lengths and repetitions, window and whole-night weighting, and exact effects and CIs are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 window and whole-night material, definitions, denominators and models" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Phase-locked closed-loop study stimulation", "needed": "EEG detection, brief pulses, intervention identity and actual exposure", "role": "Required", "role_reason": "This item distinguishes EEG detection, brief pulses, intervention identity and actual exposure to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for EEG detection, brief pulses, intervention identity and actual exposure must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing intervention identity from actual study exposure. No stimulation or acoustic-setting instructions are produced. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original study used brief closed-loop pink-noise stimulation timed to real-time detection of the rising EEG phase during sleep. It is not recast as ordinary continuous overnight playback or exposure from apps or speakers.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. Device and algorithm details, actual exposure, phase and window matching, discontinuation and implementation are unverified. Review of existing content is incomplete.", "missingness": "Device and algorithm details, actual exposure, phase and window matching, discontinuation and implementation are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 research-device and algorithm specifications and actual exposure material" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Actual sham control and awareness of conditions", "needed": "Sham exposure, sensory and contact conditions, and assessment specifications", "role": "Required", "role_reason": "This item distinguishes sham exposure, sensory and contact conditions, and assessment specifications to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for sham exposure, sensory and contact conditions, and assessment specifications must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction indicators and test adaptations are internally designed. M08 §8.1–8.2.3; internal application. M08 Table 8.2.a and M03 §3.2.4; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing control and assessment conditions. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "This was a randomized STIM-versus-sham crossover sleep-laboratory trial. The sham-intervention name is not extended into confirmation of blinding of everyone or identical contact in stage, time or arousal assessments.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. Sham composition, actual exposure, contact and expectations, awareness of conditions and assessment blinding are unverified. Review of existing content is incomplete.", "missingness": "Sham composition, actual exposure, contact and expectations, awareness of conditions and assessment blinding are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 sham, contact, blinding and condition-specific assessment records" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Population, age and baseline sleep", "needed": "Eligibility of 13 participants, health status, sleep characteristics and denominators", "role": "Required", "role_reason": "This item distinguishes eligibility of 13 participants, health status, sleep characteristics and denominators to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for eligibility of 13 participants, health status, sleep characteristics and denominators must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.1; detailed population conditions are internally designed. M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing direct population-specific evidence. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The direct population consisted of 13 healthy adults aged 60–84. Findings are not extended into whole-night effects in people with insomnia or sleep disorders, or every age group and baseline sleep status.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. Recruitment, sex, baseline sleep and cognition, eligibility and condition-specific denominators are unverified. Review of existing content is incomplete.", "missingness": "Recruitment, sex, baseline sleep and cognition, eligibility and condition-specific denominators are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 eligibility, baseline sleep, characteristics and flow diagram" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "One night per condition and crossover duration", "needed": "People, conditions, nights, adaptation and washout", "role": "Required", "role_reason": "This item distinguishes people, conditions, nights, adaptation and washout to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for people, conditions, nights, adaptation and washout must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M04 §4.6.1–4.6.2 distinguishes studies and reports; cohort and outcome linkage is an internal application. M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed. M08 §8.2.2 and M15 §15.3.1; internal application. M03 §3.2.1–3.2.4; detailed dose, duration and effect-modification distinctions are internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing people from conditions and nights. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "13 participants experienced one active and one sham night each. Two conditions or nights and slow-wave windows are not added as new participants, independent trials or long-term exposure counts.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. Adaptation nights, intervals and washout, period, order and carryover effects are unverified. Review of existing content is incomplete.", "missingness": "Adaptation nights, intervals and washout, period, order and carryover effects are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 night schedule, order and crossover analyses" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Randomized balance, concealment and analysis", "needed": "Condition order, allocation processes and models", "role": "Required", "role_reason": "This item distinguishes condition order, allocation processes and models to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for condition order, allocation processes and models must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 §8.1–8.2.3; internal application. M08 §8.2.2 and M15 §15.3.1; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material disclosing the crossover structure. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original text records randomized-order within-person comparison. Sequence generation, allocation concealment, period and carryover effects are not confirmed to have been fully controlled.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. Exact sequence and concealment procedures, period models and within-person analysis models are unverified. Review of existing content is incomplete.", "missingness": "Exact sequence and concealment procedures, period models and within-person analysis models are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 allocation methods, crossover SAP and original tables" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "EEG power calculation and measurement conditions", "needed": "Signals and windows, analysis units, quality and blinding", "role": "Required", "role_reason": "This item distinguishes signals and windows, analysis units, quality and blinding to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for signals and windows, analysis units, quality and blinding must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 Table 8.2.a and M03 §3.2.4; internal application. M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed. M08 §8.2.2 and M15 §15.3.1; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing physiological-power calculation from denominators. No EEG or device-setting methods are provided. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original whole-night measure is NREM SWA in μV²/Hz. Measurement conditions, frequencies and signal processing, electrodes and quality, and scoring definitions are not treated as all verified by the original summary.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Signal processing, window and stage definitions, quality exclusions, blinding, denominators and correlations are unverified. Review of existing content is incomplete.", "missingness": "Signal processing, window and stage definitions, quality exclusions, blinding, denominators and correlations are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 EEG measurement and analysis, quality and blinding material" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "NREM denominators and whole-night aggregation", "needed": "Valid NREM windows, stages, time and weighting", "role": "Required", "role_reason": "This item distinguishes valid NREM windows, stages, time and weighting to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for valid NREM windows, stages, time and weighting must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material disclosing whole-night and valid-NREM aggregation. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Null whole-night NREM SWA and positive stimulation-window findings are different aggregations. Findings are not filled in as confirmation of every whole-night stage or the same NREM duration.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Valid NREM times and windows by condition, stage composition, weighting and averaging, and missingness are unverified. Review of existing content is incomplete.", "missingness": "Valid NREM times and windows by condition, stage composition, weighting and averaging, and missingness are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 sleep-stage and window material, valid denominators and aggregation methods" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Gaps in deep-sleep time and other sleep outcomes", "needed": "Stages and proportions, total sleep, sleep efficiency and quality", "role": "Required", "role_reason": "This item distinguishes stages and proportions, total sleep, sleep efficiency and quality to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for stages and proportions, total sleep, sleep efficiency and quality must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed. M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is internally designed. M08 Table 8.2.a and M04 §4.6.3; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material reporting sleep stages and time separately from physiological power. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original quantitative values are not converted into original values or effects for N3 time, total sleep time, sleep efficiency or subjective sleep quality. Whole-night SWA P=.80 does not establish null findings for each other endpoint.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Exact stage and time values, efficiency and quality, arousals and fragmentation, denominators, CIs and P values, and hierarchy are unverified. Review of existing content is incomplete.", "missingness": "Exact stage and time values, efficiency and quality, arousals and fragmentation, denominators, CIs and P values, and hierarchy are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 complete sleep outcomes, definitions, denominators and analysis tables" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Effects, CIs, relevance and equivalence", "needed": "Whole-night estimands, uncertainty and adjudication specifications", "role": "Required", "role_reason": "This item distinguishes whole-night estimands, uncertainty and adjudication specifications to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for whole-night estimands, uncertainty and adjudication specifications must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptations are internally designed. M15 §15.3.1–15.3.3; internal application. M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing nonsignificance from uncertainty. No new effect or CI is produced. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Nonsignificant P=.80 is retained and is not converted into proof of an exactly zero effect or equivalence. The approximately 8% ON-window signal is not used as a whole-night effect size or CI.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Exact whole-night SWA effects and CIs, relevance criteria and equivalence specifications are unverified. Review of existing content is incomplete.", "missingness": "Exact whole-night SWA effects and CIs, relevance criteria and equivalence specifications are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 whole-night effects, CIs and prespecified interpretation material" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Memory improvement is another endpoint", "needed": "Paired-word change, sleep physiology and directness", "role": "Required", "role_reason": "This item distinguishes paired-word change, sleep physiology and directness to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for paired-word change, sleep physiology and directness must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap designs; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is a Chamgap design; M03 §3.2.4; Chamgap's own extrapolation boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material reporting functional and physiological endpoints separately. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Overnight recall improvement of 9.2 versus 3.1 words, P=.02, is a memory finding. It is not used as a substitute outcome showing that whole-night SWA or deep-sleep stages or time increased.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. Direct correspondence and relevance between memory and sleep stages or time are unverified. Review of existing content is incomplete.", "missingness": "Direct correspondence and relevance between memory and sleep stages or time are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 original endpoint-specific memory and sleep tables and denominators" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Memory–SWA association is not a whole-night effect", "needed": "Windows included in association analyses, models, causation and mediation", "role": "Required", "role_reason": "This item distinguishes windows included in association analyses, models, causation and mediation to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for windows included in association analyses, models, causation and mediation must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 §8.2.2 and M15 §15.3.1; internal application. M08 Table 8.2.a and M04 §4.6.3; internal application. M03 §3.2.4; internally defined limits on extension.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing association from whole-night effects. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original text describes an association between memory and slow-wave changes. It is not converted into causal proof of increased whole-night slow waves or deep sleep, or individual treatment effects.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. Association windows and denominators, coefficients and CIs, prespecification and mediation specifications are unverified. Review of existing content is incomplete.", "missingness": "Association windows and denominators, coefficients and CIs, prespecification and mediation specifications are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 association analyses, window definitions and plans" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Person, night, stimulus and window denominators", "needed": "Within-person repetition, aggregation, clustering and correlation", "role": "Required", "role_reason": "This item distinguishes within-person repetition, aggregation, clustering and correlation to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for within-person repetition, aggregation, clustering and correlation must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptations are internally designed. M04 §4.6.1–4.6.2 distinguishes studies and reports; cohort and outcome linkage is an internal application. M08 §8.2.2 and M15 §15.3.1; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing units in repeated data. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "13 participants with one night per condition is the original denominator description. Stimulation pulses, EEG windows, repeated tests and related sheets are not added as new independent people or trial denominators.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Person-specific stimulation and window counts, valid nights, clustering and correlation, and endpoint-specific denominators are unverified. Review of existing content is incomplete.", "missingness": "Person-specific stimulation and window counts, valid nights, clustering and correlation, and endpoint-specific denominators are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 denominators and models by person, condition and window" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Valid nights, withdrawals, missingness and ITT", "needed": "Analyses and exclusions by condition, signal and stage", "role": "Required", "role_reason": "This item distinguishes analyses and exclusions by condition, signal and stage to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for analyses and exclusions by condition, signal and stage must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing participants from actual analysis data. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "13 participants in the original material is not used as confirmation of complete EEG, stage and time analyses, completion by everyone, or ITT and PP populations.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Valid nights and windows, missing conditions and endpoints, withdrawals, exclusions and handling, and analysis populations are unverified. Review of existing content is incomplete.", "missingness": "Valid nights and windows, missing conditions and endpoints, withdrawals, exclusions and handling, and analysis populations are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 flow diagram, missing signals and endpoints, and analysis populations" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Concurrent exposures and sleep conditions during each night", "needed": "Baseline sleep, lifestyle and medication, actual exposure and arousals", "role": "Required", "role_reason": "This item distinguishes baseline sleep, lifestyle and medication, actual exposure and arousals to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for baseline sleep, lifestyle and medication, actual exposure and arousals must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; our own application; M08 §8.2.2, M15 §15.3.1; our own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material linking concurrent exposures to sleep analyses. No sleep or treatment instructions are provided. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original statement describes a crossover sleep-laboratory experiment. It is not automatically interpreted as absence of differences in baseline sleep, medication and lifestyle, night-specific contact or stimulation, and arousals.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Concurrent care, lifestyle and medication, baseline and night-specific sleep, and exposure by group or condition are unverified. Review of existing content is incomplete.", "missingness": "Concurrent care, lifestyle and medication, baseline and night-specific sleep, and exposure by group or condition are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 sleep, lifestyle, concurrent care and actual stimulation and arousal records" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Registration and prespecified whole-night and local hierarchy", "needed": "Endpoint classification, plans and registration, and amendments", "role": "Required", "role_reason": "This item distinguishes endpoint classification, plans and registration, and amendments to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for endpoint classification, plans and registration, and amendments must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M08 Table 8.2.a and M04 §4.6.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing prespecified specifications from actual aggregation scope. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The first evidence record has no registration-identifier entry, and the citation has no registration number. The parent's grouping of whole-night and stimulation-window SWA and memory is not used to establish the first prespecified endpoint or verification of every analysis specification.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Existence of registration, protocol, SAP, whole-night, local-window and stage hierarchy, and amendments are unverified. Review of existing content is incomplete.", "missingness": "Existence of registration, protocol, SAP, whole-night, local-window and stage hierarchy, and amendments are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 registration, protocol, SAP and original version" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Multiple windows, endpoints and nonsignificant findings", "needed": "Testing contrasts, selection, multiplicity and complete outcomes", "role": "Required", "role_reason": "This item distinguishes testing contrasts, selection, multiplicity and complete outcomes to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for testing contrasts, selection, multiplicity and complete outcomes must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is internally designed. M08 Table 8.2.a and M04 §4.6.3; internal application. M08 §8.2.2 and M15 §15.3.1; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material disclosing nonsignificant and local findings together. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Whole-night P=.80, ON-window P=.002 and memory P=.02 concern different endpoints. Whole-night nonsignificance is not omitted, and a positive ON finding is not used to create whole-night or all-stage success.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. Prespecified window selection, testing models, multiplicity, complete endpoints and SAP are unverified. Review of existing content is incomplete.", "missingness": "Prespecified window selection, testing models, multiplicity, complete endpoints and SAP are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 whole-night, window and memory analyses and prespecified plans" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Same report and mentions of subsequent multiple nights", "needed": "Core and subsequent references, conditions and sheet relationships", "role": "Required", "role_reason": "This item distinguishes core and subsequent references, conditions and sheet relationships to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for core and subsequent references, conditions and sheet relationships must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose separate studies with the same specifications. Counts are not added together and independence is not certified. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The two sheets share one 2017 report and a crossover trial with 13 participants. Subsequent multiple-night exploration mentioned in the original Korean text has no linked specific reference and is not created as separate confirmation. Nights, windows and references are not counted as totals of independent trials or participants.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. Subsequent identities and findings, replication with the same whole-night endpoint specifications, and actual independence of study families are not linked. Review of existing content is incomplete.", "missingness": "Subsequent identities and findings, replication with the same whole-night endpoint specifications, and actual independence of study families are not linked.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact subsequent references, trial relationships and separate direct material" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "One night versus long-term use and generalization to devices and populations", "needed": "Direct material on repetition and persistence, other devices and indications", "role": "Required", "role_reason": "This item distinguishes direct material on repetition and persistence, other devices and indications to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for direct material on repetition and persistence, other devices and indications must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M03 §3.2.4; custom extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose separate direct research for different questions. No device, acoustic, cognitive-training or treatment-replacement instructions are provided. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "This was a one-night study per condition; ordinary continuous sound, speakers and apps were not tested. Effects are not extended to other populations and devices, repeated or long-term sleep, cognition or treatment of disorders.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Other ages, disorders and devices, repeated or long-term whole-night sleep, and clinical outcomes are not linked. Review of existing content is incomplete.", "missingness": "Other ages, disorders and devices, repeated or long-term whole-night sleep, and clinical outcomes are not linked.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct effects and safety material for different specifications" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Funding, patents and product involvement", "needed": "Public support, development and patents, and COI roles", "role": "Required", "role_reason": "This item distinguishes public support, development and patents, and COI roles to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for public support, development and patents, and COI roles must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing roles and support. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Public NIA, NSF and NINDS support and disclosure of related technology patent applications are recorded. Public funding or a university reference is not used as verification of complete product involvement, patents or COI, or certification of independent efficacy.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. Support roles, devices and free support, developers and employee authors, and complete patent and COI information are unverified. Review of existing content is incomplete.", "missingness": "Support roles, devices and free support, developers and employee authors, and complete patent and COI information are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 original support, development and products, contributions and affiliations, patents and COI" }, { "item_id": "N24", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Unknown safety and fragmentation and arousal gaps", "needed": "Events and fragmentation, exposure, denominators, discontinuation and repeated-exposure harms", "role": "Supplementary", "role_reason": "This item distinguishes events and fragmentation, exposure, denominators, discontinuation and repeated-exposure harms to connect the material needed for the selected question with the material currently available.", "application_exception": "This supplements safety evidence gaps for the selected subclaim. Memory findings, stimulation-window or whole-night sleep physiology, or a parent caution are not used to adjudicate safety, create harm rates or produce new use instructions.", "criterion": "Relevant original material and analysis scope for events and fragmentation, exposure, denominators, discontinuation and repeated-exposure harms must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M19 §19.1.2–19.2.4; internal application. M19 §19.1.2–19.2.4; detailed distinctions are internally designed. M19 §19.2 covers design-specific harm questions; detailed temporal relationships are internally designed. M19 §19.2.2–19.2.4 and M03 §3.2.3; internal application. M19 §19.1.2–19.2.4; internal application. M19 §19.2.2–19.2.4 considers design; detailed confounding records are internally designed. M19 §19.1.2–19.2.4 and M04 §4.6.3; internal application. M19 §19.1.2–19.2.4; internal application. Interpretation boundaries are internally defined, informed by M19 principles; no official causality tool is executed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material collecting efficacy and safety separately. No implementation or treatment instructions are provided. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The parent's unknown safety status and original statement that a 13-person, one-night study cannot assess uncommon adverse effects or sleep fragmentation with repeated use are retained. Null whole-night SWA and an ON-window signal are not converted into absence of harms or sleep safety.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Adverse-event, arousal and fragmentation definitions, collection, condition-specific denominators, and repeated-exposure, long-term and vulnerable-population harms are unverified. 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It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for stored-summary use, unread material and additional material must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M04 §4.5–4.6 covers material collection and selection; distinctions between access and reading and hyperlink specifications are internally designed. M04 §4.6.1–4.6.2 distinguishes studies and reports; cohort and outcome linkage is an internal application. M04 §4.5 and §4.6.3; current evidence-conversion limits reflect review scope and internal design.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "If material is provided, update the content while recording its original form and actual access scope. This is a proposal; no new investigation, calculation or experiment has been performed.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The stored summary and reference were used for production, and links are retained. Abstract, full text, registration, protocol, SAP, patents and COI material were unread, access was not attempted, and link-function testing was not performed.", "condition_status": "Partly verified", "status_reason": "Only the relevant stored-summary information is recorded; detailed original material has not been read and review of existing content is incomplete. Acquisition of original material, external reading, link verification and review of existing content are pending. Review of existing content is incomplete.", "missingness": "Acquisition of original material, external reading, link verification and review of existing content are pending.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific original material, registration, plans, patent and support material, and comments" } ], "reports": [ { "report_id": "S01", "title": "Papalambros NA et al. 2017", "url": "https://pubmed.ncbi.nlm.nih.gov/28337134/", "report_type": "Randomized STIM-versus-sham crossover sleep-laboratory trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2981-PAPALAMBROS-2017", "independent_replication": null, "observed_result": "Whole-night SWA P=.80; ON-window SWA approximately +8%, P=.002; recall improvement +9.2 versus +3.1 words, P=.02", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/28337134/" } ] } ], "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review remains incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01, Papalambros2017, is a randomized within-person STIM-versus-sham crossover sleep-laboratory report involving 13 healthy adults aged 60–84, with one night per condition. The two sheets share the same reference, trial and participants. Overnight paired-word recall improvement of 9.2 versus 3.1 words, P=.02, whole-night NREM SWA of 121.7 versus 124.4 μV²/Hz, P=.80, and an approximately 8% ON-window increase, P=.002, are separate endpoints or aggregations. Recall change is not converted into final absolute scores, and a local SWA signal is not converted into whole-night N3 time or proportion. Subsequent multiple-night studies mentioned in the original Korean text have no linked specific reference, denominator or result and are not created as new reports. Conditions, nights, words, EEG windows and related sheets are not added as new independent trials or participants. Report counts are not totals of unique clinical trials, participants or independent replications." }, "history": [ { "date": "2026-10-15", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The reader view and materials were prepared from the existing 26 items. No new clinical search, verification-status changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-15" }