{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2981-s0", "verdict_number": "2981", "title": "Phase-locked closed-loop acoustic stimulation × Improved next-day paired-word memory", "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": "Brief closed-loop pink-noise pulses timed by real-time detection of the rising phase of EEG slow waves during sleep. Ordinary continuous sound and consumer apps or speakers were not tested. No device, acoustic or stimulation settings or instructions for sleep or cognitive training are produced.", "dose": "Only original study exposure of one night per condition is retained. Actual pulse counts, phases and windows, and exposure settings are unverified; no new conversion or implementation settings are produced.", "comparator": "Randomized within-person STIM-versus-sham crossover. Actual sham composition, contact, awareness of conditions, blinding, order, washout and period models are unverified.", "endpoint": "Overnight paired-word recall improvement of 9.2 versus 3.1 words, P=.02, is a change measure, not the final absolute next-day raw score or a newly calculated difference or CI. Whole-night NREM SWA of 121.7 versus 124.4 μV²/Hz, P=.80, and an approximately 8% increase during ON windows, P=.002, are physiological findings with different scopes. Association between memory and SWA changes is not confirmation of causation or mediation.", "duration": "One night each under active and sham conditions, with next-day paired-word testing. Specific reports and clinical outcomes for durable cognition, everyday memory, repeated exposure or subsequent multiple nights are not linked.", "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 memory question and original grade", "needed": "Selected wording, note and grade versus the parent verdict", "role": "Required", "role_reason": "This item distinguishes selected wording, note and grade versus the parent verdict 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 the parent verdict 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": "Record update events while distinguishing paired-word memory from the parent sleep-physiology question. 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 “Improved next-day paired-word memory”, with grade C and a note of a positive result in one small crossover trial. Subclaim score, status and axes are absent; parent C54 is not used to fill the subclaim score.", "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 editorial comments" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Population, eligibility and denominators", "needed": "Healthy adults aged 60–84, baseline sleep and cognition, and analysis counts", "role": "Required", "role_reason": "This item distinguishes healthy adults aged 60–84, baseline sleep and cognition, and analysis counts 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 healthy adults aged 60–84, baseline sleep and cognition, and analysis counts 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 the population from memory-analysis denominators. 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": "S01 involved 13 healthy adults aged 60–84, with one night per condition. A title referring to older adults is not extended into effects in every age group or in people with sleep or cognitive disorders.", "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. Detailed eligibility, recruitment, sex, baseline cognition and sleep, and condition-specific analysis denominators are unverified. Review of existing content is incomplete.", "missingness": "Detailed eligibility, recruitment, sex, baseline cognition and sleep, and condition-specific analysis 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 characteristics, recruitment and flow diagram" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Identity of phase-locked closed-loop stimulation", "needed": "EEG detection, brief pulses and actual exposure records", "role": "Required", "role_reason": "This item distinguishes EEG detection, brief pulses and actual exposure records 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 and actual exposure records 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 study exposure. No device, acoustic or stimulation-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 intervention was brief closed-loop pink-noise stimulation timed in real time to the rising phase of EEG slow waves during sleep. It is not recast as the same effect from ordinary continuous sound, speakers or apps.", "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 matching and implementation are unverified. Review of existing content is incomplete.", "missingness": "Device and algorithm details, actual exposure, phase matching 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 records" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Actual STIM-versus-sham comparison", "needed": "Active and sham conditions, exposure, contact and awareness", "role": "Required", "role_reason": "This item distinguishes active and sham conditions, exposure, contact and awareness 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 active and sham conditions, exposure, contact and awareness 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 actual control 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": "S01 was a randomized STIM-versus-sham crossover sleep-laboratory trial. The design name is not extended into confirmation of actual sham composition, sensory and contact matching, or participant awareness.", "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 by condition, expectations and awareness of conditions, and contact differences are unverified. Review of existing content is incomplete.", "missingness": "Sham composition, actual exposure by condition, expectations and awareness of conditions, and contact differences 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, exposure and expectation records" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "One night per condition and crossover order", "needed": "Conditions, nights, washout, period and carryover effects", "role": "Required", "role_reason": "This item distinguishes conditions, nights, washout, period and carryover effects 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 conditions, nights, washout, period and carryover effects 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 measurement nights and 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": "The crossover structure involved 13 participants experiencing one active and one sham night each. The two conditions or nights are not added as separate participant groups or long-term repeated exposure.", "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 between conditions, washout, period, order and carryover effects are unverified. Review of existing content is incomplete.", "missingness": "Adaptation nights, intervals between conditions, 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, washout and crossover analyses" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Randomized order and concealment processes", "needed": "Sequence generation, concealment, recruitment and condition order", "role": "Required", "role_reason": "This item distinguishes sequence generation, concealment, recruitment and condition order 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 sequence generation, concealment, recruitment and condition order 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 crossover allocation and within-person analyses. 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. The strengths of within-person comparison are retained, while sequence generation, concealment and control of period effects are not all verified.", "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. Sequence generation and concealment, responsible personnel, processes before and after recruitment, and exact analysis models are unverified. Review of existing content is incomplete.", "missingness": "Sequence generation and concealment, responsible personnel, processes before and after recruitment, and exact 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 sequence allocation, methods and SAP" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Blinding and memory-assessment conditions", "needed": "Blinding and expectations of participants, assessors and analysts", "role": "Required", "role_reason": "This item distinguishes blinding and expectations of participants, assessors and analysts 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 blinding and expectations of participants, assessors and analysts 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; Chamgap adaptation; M08 §§8.1–8.2.3; 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 distinguishing memory-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": "The control was sham, but the original summary lacks details of memory-assessor and analyst blinding. A sham condition alone does not confirm complete blinding or exclusion of expectation effects.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Participant, assessor and analyst awareness, maintenance of blinding, and assessment contact are unverified. Review of existing content is incomplete.", "missingness": "Participant, assessor and analyst awareness, maintenance of blinding, and assessment contact 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 blinding, assessment, analysis and expectation procedures" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Paired-word task and overnight-improvement definition", "needed": "Learning and testing times, recall, change and units", "role": "Required", "role_reason": "This item distinguishes learning and testing times, recall, change 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 learning and testing times, recall, change 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 our own design; M08 Table 8.2.a, M03 §3.2.4; 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 separating change from raw scores. No cognitive-training 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 endpoint was overnight paired-word recall and next-day memory consolidation. Improvement values are distinguished from absolute next-day raw recall scores and other memory tasks.", "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. Number of word pairs, baseline learning and immediate recall, next-day testing time, change calculation and testing methods are unverified. Review of existing content is incomplete.", "missingness": "Number of word pairs, baseline learning and immediate recall, next-day testing time, change calculation and testing methods 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 task, learning and recall schedule, and original tables" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Original recall improvement of 9.2 versus 3.1 and P", "needed": "Condition-specific improvement, between-group or within-person estimates, and denominators", "role": "Required", "role_reason": "This item distinguishes condition-specific improvement, between-group or within-person estimates, 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 condition-specific improvement, between-group or within-person estimates, and denominators 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; M15 §15.3.1–15.3.3; 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 linking original values to comparative estimands. No new arithmetic is performed. 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 the original statement. It is not recalculated into absolute next-day scores, a new difference or standardized effect, CIs or individual response rates.", "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 estimands, baseline and period adjustment, denominators, CIs and individual distributions are unverified. Review of existing content is incomplete.", "missingness": "Exact within-person estimands, baseline and period adjustment, denominators, CIs and individual distributions 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 memory tables, denominators and crossover estimation models" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Memory effect size, uncertainty and importance", "needed": "Original standardized estimates, CIs and relevance criteria", "role": "Required", "role_reason": "This item distinguishes original standardized estimates, CIs and relevance criteria 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 standardized estimates, CIs and relevance criteria must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M15 §15.3.1–15.3.3; internal application. M03 §3.2.4; internally defined limits on extension. 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": "Propose subsequent material distinguishing laboratory effects from importance and uncertainty. 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 record describes the standardized memory-change effect as at least moderate. This historical interpretation is not converted into a new standardized number, clinical importance or improvement for every individual.", "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 standardized estimates and CIs, relevance criteria and correspondence to everyday function are unverified. Review of existing content is incomplete.", "missingness": "Exact standardized estimates and CIs, relevance criteria and correspondence to everyday function 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 effect tables, interpretation criteria and original version" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Nonsignificant whole-night NREM SWA", "needed": "Separate memory findings from whole-night sleep physiology", "role": "Required", "role_reason": "This item distinguishes separate memory findings from whole-night sleep physiology 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 separate memory findings from whole-night sleep physiology 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 memory and sleep-physiology 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": "Whole-night NREM slow-wave activity of 121.7 versus 124.4 μV²/Hz, P=.80, is the original statement of no difference. The memory signal is not transferred into increased whole-night slow-wave activity or deep-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. Whole-night SWA measurement and denominators, exact effects and CIs, and correspondence to deep-sleep stages and time are unverified. Review of existing content is incomplete.", "missingness": "Whole-night SWA measurement and denominators, exact effects and CIs, and correspondence to deep-sleep stages and 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 whole-night NREM, stage and time tables, and denominators" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Local physiological signal during ON windows", "needed": "Distinguish windows, units and comparisons from the whole night", "role": "Required", "role_reason": "This item distinguishes distinguish windows, units and comparisons from the whole night 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 distinguish windows, units and comparisons from the whole night 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 separating local windows from 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": "An approximately 8% increase in slow-wave activity during stimulation ON windows, P=.002, is a short-window finding. It is not used as an increase in whole-night SWA, N3 time or proportion, or other sleep stages.", "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. Window definitions, ON/OFF matching, denominators and repetitions, and exact effects and CIs are unverified. Review of existing content is incomplete.", "missingness": "Window definitions, ON/OFF matching, denominators and repetitions, 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 stimulation-window and whole-night tables, window definitions and denominators" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Memory–SWA association versus causation", "needed": "Association analyses, prespecification, denominators and models", "role": "Required", "role_reason": "This item distinguishes association analyses, prespecification, denominators 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 association analyses, prespecification, denominators 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 §8.2.2 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 separating association from causal attribution. 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 states that memory changes were associated with slow-wave-activity changes. Correlation or association is not used as proof of causation or mediation showing that physiological changes fully explain the memory effect.", "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 coefficients, CIs and P values, prespecification, denominators, covariates and mediation specifications are unverified. Review of existing content is incomplete.", "missingness": "Exact coefficients, CIs and P values, prespecification, denominators, covariates 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 original association and mediation analyses, plans and denominators" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Other memory and everyday-cognition outcomes", "needed": "Task-specific endpoints, everyday function and persistence", "role": "Required", "role_reason": "This item distinguishes task-specific endpoints, everyday function and persistence 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 task-specific endpoints, everyday function and persistence must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.4; internally defined 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 subsequent research distinguishing test tasks from clinical and everyday function. 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": "Next-day paired-word testing is a functional test. The original text states that durable cognition and everyday memory improvement were not tested. The finding is not extended to other memory tasks, dementia treatment or everyday function.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Other tasks, everyday function, durable cognition and disease outcomes are not linked. Review of existing content is incomplete.", "missingness": "Other tasks, everyday function, durable cognition and disease 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 material on other functional and clinical endpoints" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Task learning, word lists and baseline differences", "needed": "Repeated tasks, lists, difficulty and period matching", "role": "Required", "role_reason": "This item distinguishes repeated tasks, lists, difficulty and period matching 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 repeated tasks, lists, difficulty and period matching 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. 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 learning from condition 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 structure involves condition-specific learning and recall in the same people. The crossover design alone does not establish that list difficulty, practice, baseline differences, or period and carryover effects were eliminated.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. List and difficulty matching, practice, baseline recall and period adjustment are unverified. Review of existing content is incomplete.", "missingness": "List and difficulty matching, practice, baseline recall and period adjustment 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 task lists, baseline and repeated tests, and crossover analyses" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "13 participants versus night, task and stimulation analysis units", "needed": "Denominators by person, condition, memory task and window", "role": "Required", "role_reason": "This item distinguishes denominators by person, condition, memory task and window 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 denominators by person, condition, memory task and window 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, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom 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 are retained as originally recorded. Nights, words, stimulus counts and EEG windows are not added as new participants or independent-trial analysis denominators.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Valid denominators by memory and EEG outcome, repetition counts, within-person correlation and exclusion criteria are unverified. Review of existing content is incomplete.", "missingness": "Valid denominators by memory and EEG outcome, repetition counts, within-person correlation and exclusion criteria 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 analysis units, denominators and models by person, condition and window" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Withdrawals, valid nights, missingness and analysis populations", "needed": "Completion, missing conditions and endpoints, ITT and PP", "role": "Required", "role_reason": "This item distinguishes completion, missing conditions and endpoints, ITT and PP 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 completion, missing conditions and endpoints, ITT and PP 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 completion 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 summary is a participant description. Valid data from everyone for each night, memory test or EEG measure, completion and ITT or PP populations are not automatically filled in.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Valid nights by condition, missing tests, withdrawals and exclusions, analysis populations and missing-data handling are unverified. Review of existing content is incomplete.", "missingness": "Valid nights by condition, missing tests, withdrawals and exclusions, analysis populations and missing-data handling 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, valid-night and endpoint denominators, and missingness reasons" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Prespecified memory hierarchy, registration and SAP", "needed": "Endpoint classification, registration, protocol and amendments", "role": "Required", "role_reason": "This item distinguishes endpoint classification, registration, protocol 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, registration, protocol 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 reported functional and physiological endpoints. 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 memory and SWA endpoints is not used to establish the first endpoint before recruitment or complete preregistration verification.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Existence of registration, prespecified memory and SWA hierarchy, protocol, SAP and amendments are unverified. Review of existing content is incomplete.", "missingness": "Existence of registration, prespecified memory and SWA hierarchy, protocol, SAP 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": "N19", "question_type": "Evidence condition", "question": "Multiple endpoints, windows and testing models", "needed": "Memory, whole-night and window-specific contrasts, multiplicity and plans", "role": "Required", "role_reason": "This item distinguishes memory, whole-night and window-specific contrasts, multiplicity and plans 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 memory, whole-night and window-specific contrasts, multiplicity and plans 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, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation 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 disclosing every endpoint and prespecified contrast. 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": "Memory P=.02, ON-window P=.002 and whole-night SWA P=.80 concern different endpoints and scopes. Some significant findings are not used to establish success on every endpoint or proof of multiplicity control.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Exact tests, baseline and period models, multiplicity, and window and endpoint selection plans are unverified. Review of existing content is incomplete.", "missingness": "Exact tests, baseline and period models, multiplicity, and window and endpoint selection plans 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 SAP and whole-night, window and memory analysis tables" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Sleep, lifestyle and concurrent exposures", "needed": "Sleep status, medication, lifestyle, actual stimulation and contact", "role": "Required", "role_reason": "This item distinguishes sleep status, medication, lifestyle, actual stimulation and contact 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 sleep status, medication, lifestyle, actual stimulation and contact 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 functional and physiological analyses. No sleep or stimulation-setting 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 sleep-laboratory comparison per condition. The original summary is not extended into confirmation that baseline sleep, lifestyle, medication and actual stimulation exposure were identical or fully controlled.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Medication and lifestyle, sleep status, actual exposure by night, and arousal and contact differences are unverified. Review of existing content is incomplete.", "missingness": "Medication and lifestyle, sleep status, actual exposure by night, and arousal and contact differences 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 records" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "One night versus mentions of subsequent multiple nights", "needed": "Direct report, exposure duration and unlinked subsequent references", "role": "Required", "role_reason": "This item distinguishes direct report, exposure duration and unlinked subsequent references 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 report, exposure duration and unlinked subsequent references 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. M04 §4.6.1–4.6.2 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 material linking subsequent durations to direct findings. 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 Korean counterpoint mentions exploration in subsequent multiple-night studies, but the citation list contains one core 2017 report. Exact subsequent reports, denominators and findings are not linked and are not created as new reports or independent confirmation.", "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 report identities, populations, nights and stimulation, memory specifications and quantitative effects are not linked. Review of existing content is incomplete.", "missingness": "Subsequent report identities, populations, nights and stimulation, memory specifications and quantitative effects 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 references, original findings and trial relationships for subsequent mentions" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Same trial, related sheets and independent replication", "needed": "Reference, 13 participants, conditions, windows and sheet relationships", "role": "Required", "role_reason": "This item distinguishes reference, 13 participants, conditions, windows 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 reference, 13 participants, conditions, windows 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. Independence is not certified and counts are not added 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": "The two sheets share the same Papalambros2017 crossover trial with 13 participants. Memory and SWA, conditions and nights, patents and references, or related sheets are not added as new independent trials or participant replications.", "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 replication with matching populations, stimulation and memory specifications, and relationships among independent study families are not linked. Review of existing content is incomplete.", "missingness": "Separate replication with matching populations, stimulation and memory specifications, and relationships among independent 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": "Report, condition and sheet relationships and separate direct trials" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Ordinary sound, consumer devices and other populations", "needed": "Direct material by device, intervention and eligibility", "role": "Required", "role_reason": "This item distinguishes direct material by device, intervention and eligibility 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 by device, intervention and eligibility 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 our own design; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own 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 separate direct research for different questions. No device, acoustic, training or treatment-replacement 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 text states that ordinary continuous overnight pink noise and consumer speakers or apps were not tested. Findings are not transferred into memory efficacy for other devices, continuous sound, populations or disorders.", "condition_status": "Unverified", "status_reason": "The information currently needed is unverified in the stored summary. Direct effects and safety for other devices, settings, populations and clinical indications are not linked. Review of existing content is incomplete.", "missingness": "Direct effects and safety for other devices, settings, populations and clinical indications 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 designs and direct findings for other interventions and populations" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Public support, patents and interests", "needed": "Funding, development and products, patents and COI roles", "role": "Required", "role_reason": "This item distinguishes funding, development and products, 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 funding, development and products, 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 support from patents and developer roles. 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": "Funding records list public NIA, NSF and NINDS support and disclosure of related technology patent applications. Public funding is not used to fill in complete verification of patents, products or author interests, 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, products and free support, developers and employee authors, patent scope and complete COI information are unverified. Review of existing content is incomplete.", "missingness": "Support roles, products and free support, developers and employee authors, patent scope and complete 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 funding, product and development support, affiliations and contributions, patents and COI" }, { "item_id": "N25", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "One-night safety and sleep-fragmentation gaps", "needed": "Event collection, arousals and fragmentation, denominators, repeated and long-term exposure", "role": "Supplementary", "role_reason": "This item distinguishes event collection, arousals and fragmentation, denominators, repeated and long-term exposure 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 event collection, arousals and fragmentation, denominators, repeated and long-term exposure 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 safety and effects separately. No device, sleep or treatment implementation 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 parent's safety status is unknown. The original record states that a 13-person, one-night study cannot assess uncommon adverse effects or sleep fragmentation with repeated use. 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Review of existing content is incomplete.", "missingness": "Subclaim score, status and axes, details of historical verification, new corrections and external comparisons 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": "Original version, material used at the time, corrections and comments" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Actual summary reading, links and updates", "needed": "Stored-summary use, unread external material and additional material", "role": "Required", "role_reason": "This item distinguishes stored-summary use, unread external material and additional material 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 stored-summary use, unread external 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. 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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": "Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-15" }