{ "schema_version": "chamgap-public-criteria-1.0", "title": "Phase-locked closed-loop acoustic stimulation × Improved next-day paired-word memory", "language": "en", "translation_date": "2026-10-15", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "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." }, "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." }, { "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. 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This is a proposal; no new investigation, calculation or experiment has been performed." }, { "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." }, { "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. 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This is a proposal; no new investigation, calculation or experiment has been performed." }, { "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. 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This is a proposal; no new investigation, calculation or experiment has been performed." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Original axes, bilingual text, dates, corrections and history", "needed": "Preserve parent C54, subclaim C and original verdict and review records", "role": "Required", "role_reason": "This item distinguishes preserve parent C54, subclaim C and original verdict and review 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 preserve parent C54, subclaim C and original verdict and review records 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, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules 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": "Record historical verdicts separately from production and update events. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "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." } ] }