{ "schema_version": "chamgap-public-criteria-1.0", "title": "Phase-locked closed-loop acoustic stimulation × Increased whole-night deep sleep", "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 whole-night question and original grade", "needed": "Selected wording, note and grade versus local-window and memory questions", "role": "Required", "role_reason": "This item distinguishes selected wording, note and grade versus local-window and memory questions to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for selected wording, note and grade versus local-window and memory questions must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Update the record while distinguishing the whole night from stimulation windows and memory questions. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Definitions of SWA and deep-sleep stages and time", "needed": "Whole-night NREM power, N3 and stages, proportions and time", "role": "Required", "role_reason": "This item distinguishes whole-night NREM power, N3 and stages, proportions and time to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for whole-night NREM power, N3 and stages, proportions and time must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material separating physiological power from stages and time. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Whole-night NREM 121.7 versus 124.4 and P", "needed": "Original whole-night values, comparisons and exact estimands", "role": "Required", "role_reason": "This item distinguishes original whole-night values, comparisons and exact estimands to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for original whole-night values, comparisons and exact estimands must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptations are internally designed. M08 §8.2.2 and M15 §15.3.1; internal application. M15 §15.3.1–15.3.3; internal application. M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing nonsignificance from estimation uncertainty. No new difference or CI is calculated. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Approximately 8% during ON windows versus the whole night", "needed": "Short windows, whole-night averages, denominators and units", "role": "Required", "role_reason": "This item distinguishes short windows, whole-night averages, denominators and units to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for short windows, whole-night averages, denominators and units must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material disclosing separate specifications for local windows and the whole night. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Phase-locked closed-loop study stimulation", "needed": "EEG detection, brief pulses, intervention identity and actual exposure", "role": "Required", "role_reason": "This item distinguishes EEG detection, brief pulses, intervention identity and actual exposure to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for EEG detection, brief pulses, intervention identity and actual exposure must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing intervention identity from actual study exposure. No stimulation or acoustic-setting instructions are produced. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Actual sham control and awareness of conditions", "needed": "Sham exposure, sensory and contact conditions, and assessment specifications", "role": "Required", "role_reason": "This item distinguishes sham exposure, sensory and contact conditions, and assessment specifications to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for sham exposure, sensory and contact conditions, and assessment specifications must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction indicators and test adaptations are internally designed. M08 §8.1–8.2.3; internal application. M08 Table 8.2.a and M03 §3.2.4; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing control and assessment conditions. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Population, age and baseline sleep", "needed": "Eligibility of 13 participants, health status, sleep characteristics and denominators", "role": "Required", "role_reason": "This item distinguishes eligibility of 13 participants, health status, sleep characteristics and denominators to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for eligibility of 13 participants, health status, sleep characteristics and denominators must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.1; detailed population conditions are internally designed. M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing direct population-specific evidence. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "One night per condition and crossover duration", "needed": "People, conditions, nights, adaptation and washout", "role": "Required", "role_reason": "This item distinguishes people, conditions, nights, adaptation and washout to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for people, conditions, nights, adaptation and washout must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M04 §4.6.1–4.6.2 distinguishes studies and reports; cohort and outcome linkage is an internal application. M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed. M08 §8.2.2 and M15 §15.3.1; internal application. M03 §3.2.1–3.2.4; detailed dose, duration and effect-modification distinctions are internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing people from conditions and nights. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Randomized balance, concealment and analysis", "needed": "Condition order, allocation processes and models", "role": "Required", "role_reason": "This item distinguishes condition order, allocation processes and models to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for condition order, allocation processes and models must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 §8.1–8.2.3; internal application. M08 §8.2.2 and M15 §15.3.1; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material disclosing the crossover structure. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "EEG power calculation and measurement conditions", "needed": "Signals and windows, analysis units, quality and blinding", "role": "Required", "role_reason": "This item distinguishes signals and windows, analysis units, quality and blinding to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for signals and windows, analysis units, quality and blinding must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 Table 8.2.a and M03 §3.2.4; internal application. M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed. M08 §8.2.2 and M15 §15.3.1; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing physiological-power calculation from denominators. No EEG or device-setting methods are provided. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "NREM denominators and whole-night aggregation", "needed": "Valid NREM windows, stages, time and weighting", "role": "Required", "role_reason": "This item distinguishes valid NREM windows, stages, time and weighting to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for valid NREM windows, stages, time and weighting must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material disclosing whole-night and valid-NREM aggregation. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Gaps in deep-sleep time and other sleep outcomes", "needed": "Stages and proportions, total sleep, sleep efficiency and quality", "role": "Required", "role_reason": "This item distinguishes stages and proportions, total sleep, sleep efficiency and quality to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for stages and proportions, total sleep, sleep efficiency and quality must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed. M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is internally designed. M08 Table 8.2.a and M04 §4.6.3; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material reporting sleep stages and time separately from physiological power. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Effects, CIs, relevance and equivalence", "needed": "Whole-night estimands, uncertainty and adjudication specifications", "role": "Required", "role_reason": "This item distinguishes whole-night estimands, uncertainty and adjudication specifications to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for whole-night estimands, uncertainty and adjudication specifications must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptations are internally designed. M15 §15.3.1–15.3.3; internal application. M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is internally designed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing nonsignificance from uncertainty. No new effect or CI is produced. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Memory improvement is another endpoint", "needed": "Paired-word change, sleep physiology and directness", "role": "Required", "role_reason": "This item distinguishes paired-word change, sleep physiology and directness to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for paired-word change, sleep physiology and directness must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap designs; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is a Chamgap design; M03 §3.2.4; Chamgap's own extrapolation boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material reporting functional and physiological endpoints separately. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Memory–SWA association is not a whole-night effect", "needed": "Windows included in association analyses, models, causation and mediation", "role": "Required", "role_reason": "This item distinguishes windows included in association analyses, models, causation and mediation to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for windows included in association analyses, models, causation and mediation must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 §8.2.2 and M15 §15.3.1; internal application. M08 Table 8.2.a and M04 §4.6.3; internal application. M03 §3.2.4; internally defined limits on extension.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing association from whole-night effects. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Person, night, stimulus and window denominators", "needed": "Within-person repetition, aggregation, clustering and correlation", "role": "Required", "role_reason": "This item distinguishes within-person repetition, aggregation, clustering and correlation to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for within-person repetition, aggregation, clustering and correlation must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptations are internally designed. M04 §4.6.1–4.6.2 distinguishes studies and reports; cohort and outcome linkage is an internal application. M08 §8.2.2 and M15 §15.3.1; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing units in repeated data. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Valid nights, withdrawals, missingness and ITT", "needed": "Analyses and exclusions by condition, signal and stage", "role": "Required", "role_reason": "This item distinguishes analyses and exclusions by condition, signal and stage to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for analyses and exclusions by condition, signal and stage must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing participants from actual analysis data. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Concurrent exposures and sleep conditions during each night", "needed": "Baseline sleep, lifestyle and medication, actual exposure and arousals", "role": "Required", "role_reason": "This item distinguishes baseline sleep, lifestyle and medication, actual exposure and arousals to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for baseline sleep, lifestyle and medication, actual exposure and arousals must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; our own application; M08 §8.2.2, M15 §15.3.1; our own application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material linking concurrent exposures to sleep analyses. No sleep or treatment instructions are provided. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Registration and prespecified whole-night and local hierarchy", "needed": "Endpoint classification, plans and registration, and amendments", "role": "Required", "role_reason": "This item distinguishes endpoint classification, plans and registration, and amendments to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for endpoint classification, plans and registration, and amendments must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M08 Table 8.2.a and M04 §4.6.3; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing prespecified specifications from actual aggregation scope. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Multiple windows, endpoints and nonsignificant findings", "needed": "Testing contrasts, selection, multiplicity and complete outcomes", "role": "Required", "role_reason": "This item distinguishes testing contrasts, selection, multiplicity and complete outcomes to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for testing contrasts, selection, multiplicity and complete outcomes must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is internally designed. M08 Table 8.2.a and M04 §4.6.3; internal application. M08 §8.2.2 and M15 §15.3.1; internal application.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material disclosing nonsignificant and local findings together. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Same report and mentions of subsequent multiple nights", "needed": "Core and subsequent references, conditions and sheet relationships", "role": "Required", "role_reason": "This item distinguishes core and subsequent references, conditions and sheet relationships to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for core and subsequent references, conditions and sheet relationships must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose separate studies with the same specifications. Counts are not added together and independence is not certified. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "One night versus long-term use and generalization to devices and populations", "needed": "Direct material on repetition and persistence, other devices and indications", "role": "Required", "role_reason": "This item distinguishes direct material on repetition and persistence, other devices and indications to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for direct material on repetition and persistence, other devices and indications must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M03 §3.2.4; custom extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose separate direct research for different questions. No device, acoustic, cognitive-training or treatment-replacement instructions are provided. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Funding, patents and product involvement", "needed": "Public support, development and patents, and COI roles", "role": "Required", "role_reason": "This item distinguishes public support, development and patents, and COI roles to connect the material needed for the selected question with the material currently available.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for public support, development and patents, and COI roles must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material distinguishing roles and support. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N24", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Unknown safety and fragmentation and arousal gaps", "needed": "Events and fragmentation, exposure, denominators, discontinuation and repeated-exposure harms", "role": "Supplementary", "role_reason": "This item distinguishes events and fragmentation, exposure, denominators, discontinuation and repeated-exposure harms to connect the material needed for the selected question with the material currently available.", "application_exception": "This supplements safety evidence gaps for the selected subclaim. Memory findings, stimulation-window or whole-night sleep physiology, or a parent caution are not used to adjudicate safety, create harm rates or produce new use instructions.", "criterion": "Relevant original material and analysis scope for events and fragmentation, exposure, denominators, discontinuation and repeated-exposure harms must be provided so that unverified issues can be distinguished. Preserved wording is linked here; review of existing content is incomplete.", "basis": "M19 §19.1.2–19.2.4; internal application. M19 §19.1.2–19.2.4; detailed distinctions are internally designed. M19 §19.2 covers design-specific harm questions; detailed temporal relationships are internally designed. M19 §19.2.2–19.2.4 and M03 §3.2.3; internal application. M19 §19.1.2–19.2.4; internal application. M19 §19.2.2–19.2.4 considers design; detailed confounding records are internally designed. M19 §19.1.2–19.2.4 and M04 §4.6.3; internal application. M19 §19.1.2–19.2.4; internal application. Interpretation boundaries are internally defined, informed by M19 principles; no official causality tool is executed.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose subsequent material collecting efficacy and safety separately. No implementation or treatment instructions are provided. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Parent and subclaim values, Korean and English texts, dates and history", "needed": "Parent C54, subclaim D, axes, corrections and review", "role": "Required", "role_reason": "This item distinguishes parent C54, subclaim D, axes, corrections and review 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 parent C54, subclaim D, axes, corrections and review 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": "Distinguish verdict history from production and update events. This is a proposal; no new investigation, calculation or experiment has been performed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Actual summary reading, external links and updates", "needed": "Stored-summary use, unread material and additional material", "role": "Required", "role_reason": "This item distinguishes stored-summary use, unread 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 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." } ] }