{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "0.25 Hz rocking bed × One-night N3 proportion evidence checklist",
  "language": "en",
  "translation_date": "2026-10-11",
  "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    }
  ],
  "status_dictionary": {
    "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.",
    "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.",
    "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.",
    "Review incomplete": "Review of existing content or actual review incomplete.",
    "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.",
    "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.",
    "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.",
    "Not applicable": "Used when the reason it does not apply to the original question is stated.",
    "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Is the selected question an increase in the proportion of N3 sleep over one night?",
      "needed": "Connection between the subclaim, parent population and intervention, N3, and duration",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Is the selected question an increase in the proportion of N3 sleep over one night?",
      "application_exception": "Do not create a new verdict or split, or fill the sibling insomnia question with the same effect.",
      "criterion": "Distinguish the exact question from the verdict record.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are our own design / M03 §3.2.4; our own extension boundary",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If the question actually changes, record the original question and excluded scope separately."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Are the subclaim's grade C and note separate from the parent's C54 and axes?",
      "needed": "Actual subclaim fields and their absence, and the location of original parent values",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are the subclaim's grade C and note separate from the parent's C54 and axes?",
      "application_exception": "Do not copy the parent's score of 54 or S/R1/I2/E+/B2 into subclaim-specific values.",
      "criterion": "Retain the actual scope of subclaim and parent values.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are our own design / M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If subclaim fields are actually added, separate the original version from the new event."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Do historical verdicts, design limitations, and cross-checks constitute a current review?",
      "needed": "Korean and English verdicts, assessment axes, existing synthesis, review date, and correction history",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Do historical verdicts, design limitations, and cross-checks constitute a current review?",
      "application_exception": "Do not inherit historical cross-checks or grades as a review passed in this work or an independent subclaim verdict.",
      "criterion": "Preserve the original history while marking the original content review as incomplete.",
      "basis": "M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design / M08 §8.1–8.2.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If new evidence is requested, separate the original version from an evidence-update event."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Which materials were actually read, and which external materials remain unread?",
      "needed": "Acquisition, reading, and locations for the stored summary and each external material",
      "role": "Required",
      "role_reason": "This condition is needed to record original information and gaps separately for the question: Which materials were actually read, and which external materials remain unread?",
      "application_exception": "Do not label an existing URL or a historical reference to original text as current full-text reading or failed access.",
      "criterion": "Distinguish reading the local summary from unread external materials, by material.",
      "basis": "M04 §4.5–4.6 material-collection and selection principles; separation of access and reading and hyperlink rules are our own design / M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If materials or reading records are added, record only the actual material level."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "How are reports, registrations, and study families connected?",
      "needed": "Original bibliography, registration and trial identity, and related reports",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: How are reports, registrations, and study families connected?",
      "application_exception": "Do not turn Not confirmed into Not applicable, a registration number, or zero trials.",
      "criterion": "Preserve the original report and registration identifier, leaving undetermined unique counts null.",
      "basis": "M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort and outcome connections are Chamgap adaptations / M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation / M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If an original related-report list is provided, record same-family, recitation, and different-family relationships."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Was the actual population healthy young adults?",
      "needed": "Exact age, inclusion and exclusion criteria, and baseline sleep and vestibular characteristics",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Was the actual population healthy young adults?",
      "application_exception": "Do not extend healthy young adults to direct effects in insomnia or other age or disease groups.",
      "criterion": "Retain the original population and unverified selection and applicability scope.",
      "basis": "M03 §3.2.1; detailed population conditions are our own design / M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If the original population table is provided, distinguish actual selection criteria from gaps for other populations."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What was the rocking-bed exposure in the study?",
      "needed": "Device version, amplitude and path, actual duration and interruptions, and exposure records",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: What was the rocking-bed exposure in the study?",
      "application_exception": "Do not turn 0.25 Hz into manufacturing, setup, or use instructions, or a recommendation for an optimal frequency.",
      "criterion": "Preserve only the original lateral movement, frequency, and one-night condition.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and assessment adaptations are our own design / M03 §3.2.3, M08 §8.2.2–8.2.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original device or exposure materials are provided, distinguish nominal conditions from actual use."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Were other environmental conditions the same with the stationary bed?",
      "needed": "Stationary control, environment and noise, device conditions, and shared exposures",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Were other environmental conditions the same with the stationary bed?",
      "application_exception": "Do not turn the stationary-bed comparison into an untreated-insomnia trial or a comparison of other devices.",
      "criterion": "Distinguish the actual comparator from gaps in specific environmental conditions.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and assessment adaptations are our own design / M03 §3.2.3, M08 §8.2.2–8.2.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original comparator materials are provided, record actual shared factors and differences other than movement."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What were the crossover sequence, counterbalancing, and effects between periods?",
      "needed": "Allocation and concealment, sequence-specific denominators, period interval, adaptation, and carryover",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: What were the crossover sequence, counterbalancing, and effects between periods?",
      "application_exception": "Do not use the label counterbalanced to declare no carryover or fulfillment of all analysis conditions.",
      "criterion": "Preserve both the original sequence strength and gaps in crossover details.",
      "basis": "M08 §8.1–8.2.3; Chamgap adaptation / M08 §8.2.2, M15 §15.3.1; Chamgap adaptation / M03 §3.2.2–3.2.3; reverse-direction labels and measurement adaptations are Chamgap designs",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If the original crossover plan or analysis is provided, record sequence, period, and carryover assumptions."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are the 18 people and nights per condition repeated observations of the same people?",
      "needed": "Connections and inclusion flow for people, nights, conditions, and measurements",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are the 18 people and nights per condition repeated observations of the same people?",
      "application_exception": "Do not sum nights, two conditions, or numbers of scorers into a participant total.",
      "criterion": "Keep the original 18 people and repeated conditions as different units.",
      "basis": "M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort and outcome connections are Chamgap adaptations / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap designs",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original flow or records are provided, distinguish people from inclusion by night and endpoint."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Are recruitment, completion, and the N3 analysis denominator directly verified?",
      "needed": "Participant and condition flow, valid N3 pairs, exclusions, and missingness",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are recruitment, completion, and the N3 analysis denominator directly verified?",
      "application_exception": "Do not automatically replicate 18 as a complete analysis denominator for every endpoint and harm.",
      "criterion": "Distinguish the original study scale from endpoint-specific analysis gaps.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design / M08 §8.2.2, M15 §15.3.1; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original flow and endpoint analysis tables are provided, record study scale and actual analysis denominators."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "What are the denominator, unit, and measurement for N3?",
      "needed": "Stage definition, total-sleep denominator, scoring and recording methods, and valid intervals",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: What are the denominator, unit, and measurement for N3?",
      "application_exception": "Do not substitute increased total sleep duration or clinically restful sleep for an increased N3 proportion.",
      "criterion": "Distinguish the original measured percentage from absolute sleep duration and clinical outcomes.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations by question are our own design / M08 Table 8.2.a, M03 §3.2.4; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If the original measurement methods are provided, record N3 and total-sleep denominators, scales, and analysis windows."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "To whom did blinding of sleep-stage scoring apply?",
      "needed": "Scoring criteria, scorer agreement, unblinding, and participant and analyst blinding",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: To whom did blinding of sleep-stage scoring apply?",
      "application_exception": "Do not extend blinding of two scorers to double blinding or blinding of all procedures.",
      "criterion": "Distinguish the original scoring strength from role-specific gaps.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; our own application / M08 §8.1–8.2.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original scoring materials are provided, record role-specific blinding and the scope of scorer agreement."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What were the original N3 proportions and the ± and SEM notation?",
      "needed": "Original summary statistics, definitions of each ±, paired data, and estimated differences",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: What were the original N3 proportions and the ± and SEM notation?",
      "application_exception": "Do not subtract condition means to calculate a new percentage-point difference, SD, or paired CI.",
      "criterion": "Preserve the original proportions, ± and SEM, and adjusted P at the level of their reported notation.",
      "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, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design / M15 §15.3.1–15.3.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original results or methods are provided, distinguish condition summary statistics from paired-comparison estimates."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What were the paired effect of interest, model, and period adjustment?",
      "needed": "Crossover paired model, period and sequence, effect of interest, and variance",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: What were the paired effect of interest, model, and period adjustment?",
      "application_exception": "Do not treat crossover data as two independent parallel groups or create a new effect estimate.",
      "criterion": "Distinguish the crossover design from gaps in actual analysis details.",
      "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap adaptation / M15 §15.3.1–15.3.3; Chamgap adaptation / M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap designs",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If the original statistical plan or methods are provided, record condition values and the actual estimand."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Are historical non-reporting of a 95% CI and current unread status distinguished?",
      "needed": "Paired differences, CIs, and reporting scope in the original results",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are historical non-reporting of a 95% CI and current unread status distinguished?",
      "application_exception": "Do not recalculate a CI from SEM, P, and 18 people, or turn unread status into a current direct verification of non-reporting.",
      "criterion": "Retain the historical non-reporting account and current gap in directly verified intervals.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap designs / M15 §15.3.1–15.3.3; Chamgap adaptation / M04 §4.5–4.6 on collecting and selecting materials; separating access from reading and hyperlink rules are Chamgap designs",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original tables are provided, record actual intervals and the scope of the historical non-reporting account."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Is there a threshold for a clinically important increase in N3?",
      "needed": "Clinical importance of the measured change, direct patient outcomes, and original criteria",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Is there a threshold for a clinically important increase in N3?",
      "application_exception": "Do not turn the difference between condition proportions into a new MCID or criterion for successful restful sleep.",
      "criterion": "Preserve both the original absence-of-threshold account and the surrogate-outcome limitation.",
      "basis": "M15 §15.3.1–15.3.3; our own application / M03 §3.2.4; our own boundary on extensions",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If relevant criteria or clinical materials are provided, distinguish the N3 signal from direct clinical importance."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Which set of tests did the Bonferroni adjustment cover?",
      "needed": "Test list, adjustment family, prespecified versus exploratory analyses, and multiplicity plan",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Which set of tests did the Bonferroni adjustment cover?",
      "application_exception": "Do not certify fulfillment of all selective-reporting or multiplicity conditions from the adjusted P alone.",
      "criterion": "Distinguish the original adjustment notation from planning gaps.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation / M15 §15.3.1–15.3.3; Chamgap adaptation",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original plans or methods are provided, record each result and the actual adjustment and hierarchy."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Were a single prespecified primary endpoint and registration directly read?",
      "needed": "Original registration, protocol and SAP, endpoint hierarchy, and changes",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Were a single prespecified primary endpoint and registration directly read?",
      "application_exception": "Do not certify N3 in the selected table as a new prespecified primary endpoint or conclude that registration was absent.",
      "criterion": "Preserve the original hierarchy history and external planning gaps.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; our own application / M04 §4.5–4.6 material-collection and selection principles; separation of access and reading and hyperlink rules are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original plans are provided, distinguish prespecified, secondary, and exploratory outcomes and reporting lists."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Is the N2 sleep-onset result different from N3?",
      "needed": "N2 onset definition, denominator, ± and intervals, and analysis hierarchy",
      "role": "Supplementary",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Is the N2 sleep-onset result different from N3?",
      "application_exception": "Do not copy N3's SEM or values into N2 or extend N2 onset to an insomnia-treatment effect.",
      "criterion": "Preserve the original onset result, minutes, and adjusted P as a separate outcome.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is our own design / M03 §3.2.4; our own extension boundary",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original results or methods are provided, record onset results separately from N3 and other sleep measures."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Are total sleep duration and other sleep-stage results directly available?",
      "needed": "Values, denominators, timing, and plans for total sleep, stages, awakenings, and efficiency",
      "role": "Supplementary",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are total sleep duration and other sleep-stage results directly available?",
      "application_exception": "Do not write that total sleep increased or all sleep measures improved on the basis of an increased N3 proportion.",
      "criterion": "Leave directly unavailable overall and other sleep values unverified.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M03 §3.2.4; our own extension boundary",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original sleep tables are provided, distinguish proportions, absolute duration, and other measures."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What information is available about memory and neural oscillation results?",
      "needed": "Definitions, timing, denominators, quantitative results, and hierarchy for memory and neural measures",
      "role": "Supplementary",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: What information is available about memory and neural oscillation results?",
      "application_exception": "Do not invent memory-improvement effects, statistical significance, or clinical benefit from the title alone.",
      "criterion": "Preserve the original title while retaining gaps in direct results.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap designs / M03 §3.2.4; Chamgap's own extrapolation boundary / M04 §4.5–4.6 on collecting and selecting materials; separating access from reading and hyperlink rules are Chamgap designs",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original materials are provided, distinguish the title from actual results and analyses."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Is no difference in heart rate a different safety outcome?",
      "needed": "Heart-rate measurement and duration, denominator, effect and interval, and safety role",
      "role": "Supplementary",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Is no difference in heart rate a different safety outcome?",
      "application_exception": "Do not turn no difference in heart rate into absence of all adverse events or a guarantee of device safety.",
      "criterion": "Distinguish the original no-difference account from gaps in other harms.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is a Chamgap design / M19 §19.1.2–19.2.4; Chamgap adaptation / M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original heart-rate materials are provided, distinguish physiological measures from clinical harms."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are the hierarchy and selective reporting of all outcomes known?",
      "needed": "All planned and reported outcomes, prespecified hierarchy, adjustment, and undisclosed outcomes",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are the hierarchy and selective reporting of all outcomes known?",
      "application_exception": "Do not conclude that outcomes absent from the summary did not exist, or fill missing results with favorable title wording.",
      "criterion": "Retain the preserved direction while leaving the full reporting scope unverified.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; our own application / M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original lists are provided, distinguish reporting status from the scope of the selected table."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What were shared sleep-environment conditions and other exposures?",
      "needed": "Shared environment and schedule, concurrent exposures, and baseline characteristics and adjustments",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: What were shared sleep-environment conditions and other exposures?",
      "application_exception": "Do not create sleep-hygiene, medication-adjustment, or lifestyle instructions without original materials.",
      "criterion": "Distinguish research exposure from gaps in concurrent conditions.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation / M03 §3.2.2–3.2.3; reverse-direction labels and measurement adaptations are Chamgap designs / M19 §19.2.2–19.2.4 on design considerations; detailed confounding records are a Chamgap design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original condition records are provided, record factors other than movement and actual shared conditions."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Are missingness, attrition, actual exposure, and valid records verified?",
      "needed": "Valid nights and pairs, attrition and failures, reasons, missing-data handling, and sensitivity analyses",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are missingness, attrition, actual exposure, and valid records verified?",
      "application_exception": "Do not use the original scale of 18 people to insert complete pairs, zero attrition, or zero harms.",
      "criterion": "Distinguish direct gaps in valid data from the original study scale.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design / M08 §8.2.2, M15 §15.3.1; our own application / M19 §19.1.2–19.2.4, M04 §4.6.3; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original flow or analyses are provided, distinguish participant data from valid data and losses for each endpoint."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Is sustained improvement in insomnia the same question?",
      "needed": "Diagnosed insomnia, repeated use, patient-centered symptoms and function, and follow-up",
      "role": "Supplementary",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Is sustained improvement in insomnia the same question?",
      "application_exception": "Do not turn the sibling's ? into D or zero effect, or fill it with positive N3 results.",
      "criterion": "Preserve the sibling's original context without creating a new split, verdict, or treatment guidance.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 on clarifying questions; detailed separation rules are a Chamgap design / M03 §3.2.1–3.2.4; dose, persistence, and effect-modification details are Chamgap designs / M03 §3.2.4; Chamgap's own extrapolation boundary",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If direct clinical materials are provided, distinguish the measurement signal from sustained insomnia outcomes."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Does the evidence answer questions about other frequencies, amplitudes, or optimal conditions?",
      "needed": "Direct condition comparisons, devices and amplitudes, and prespecified dose or intensity hypotheses",
      "role": "Supplementary",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Does the evidence answer questions about other frequencies, amplitudes, or optimal conditions?",
      "application_exception": "Do not recommend all rocking, devices, or optimal settings from observations at 0.25 Hz.",
      "criterion": "Separate the original condition from gaps for other conditions.",
      "basis": "M03 §3.2.1–3.2.4; dose, persistence, and effect-modification details are Chamgap designs / M03 §3.2.2–3.2.3; reverse-direction labels and measurement adaptations are Chamgap designs",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If materials for other conditions are provided, distinguish their scope from the original comparison."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "What is the scope for other populations, durations, and subgroup effects?",
      "needed": "Direct population and baseline data, prespecified interactions, and repeated-use and post-cessation follow-up",
      "role": "Supplementary",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: What is the scope for other populations, durations, and subgroup effects?",
      "application_exception": "Do not replicate the overall measurement result as the same effect in other populations or long-term use.",
      "criterion": "Retain gaps beyond the short, selected scope.",
      "basis": "M03 §3.2.1; detailed population conditions are our own design / M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If materials are provided, distinguish the overall short measurement study from separate population and sustained-effect questions."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Are independent replication and numbers of reports or populations determined?",
      "needed": "Related reports and registrations, unique families, and condition-specific result lists",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are independent replication and numbers of reports or populations determined?",
      "application_exception": "Do not count two crossover conditions, nights, stages, memory, or sibling tables as independent replication.",
      "criterion": "Distinguish report slots from undetermined unique counts.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort and outcome linking is our own application / M04 §4.6.1–4.6.2, M15 §15.3.1; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original lists are provided, record same, different, and unclear families and report relationships."
    },
    {
      "item_id": "N31",
      "question_type": "Harm information",
      "question": "How were harms collected prospectively?",
      "needed": "Safety-event definitions, systematic and spontaneous collection, severity, and discontinuation",
      "role": "Supplementary",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: How were harms collected prospectively?",
      "application_exception": "Do not turn historical non-reporting or current unread status into zero adverse events.",
      "criterion": "Distinguish historical limitations in safety information from current unread external materials.",
      "basis": "M19 §19.1.2–19.2.4; detailed distinctions are our own design / M19 §19.1.2–19.2.4; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original safety materials are provided, record actual collection and reporting scope."
    },
    {
      "item_id": "N32",
      "question_type": "Harm information",
      "question": "Are harm denominators, events, and time known?",
      "needed": "Population and time under harm collection, events and people, and periods and conditions",
      "role": "Supplementary",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are harm denominators, events, and time known?",
      "application_exception": "Do not replicate 18 as a complete safety-analysis denominator or calculate harm frequencies.",
      "criterion": "Retain gaps in harm information without denominators.",
      "basis": "M19 §19.1.2–19.2.4; our own application / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original safety denominators are provided, record them separately from measurement and efficacy denominators."
    },
    {
      "item_id": "N33",
      "question_type": "Harm information",
      "question": "What were the timing relationships of harm onset, discontinuation, and recovery?",
      "needed": "Event timelines, exposure and discontinuation, recovery, and observation windows",
      "role": "Supplementary",
      "role_reason": "This condition records the original information and gaps for the question: What were the timing relationships of harm onset, discontinuation, and recovery?",
      "application_exception": "Do not determine zero harm occurrence or causality from observation after one night alone.",
      "criterion": "Distinguish original exposure duration from gaps in harm timing.",
      "basis": "M19 §19.2 concerns harm questions by study design; temporal-relationship details are our own design / M19 §19.1.2–19.2.4; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original event records are provided, distinguish temporal relationships from causality and denominator limitations."
    },
    {
      "item_id": "N34",
      "question_type": "Harm information",
      "question": "What were harm comparisons, concurrent exposures, and alternative explanations?",
      "needed": "Actual event-specific comparisons, baseline and concurrent exposures, alternatives, and attribution",
      "role": "Supplementary",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: What were harm comparisons, concurrent exposures, and alternative explanations?",
      "application_exception": "Do not conclude absence of other harms or alternative causes from no difference in heart rate.",
      "criterion": "Distinguish control and physiological signals from direct harm gaps.",
      "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation / M19 §19.2.2–19.2.4 on design considerations; detailed confounding records are a Chamgap design / M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original safety and condition materials are provided, distinguish physiological measures from harms and alternative explanations."
    },
    {
      "item_id": "N35",
      "question_type": "Harm information",
      "question": "Are missing harm collection, discontinuation, and completeness verified?",
      "needed": "Safety reporting and monitoring, discontinuation and omissions, and disclosure scope for all events",
      "role": "Supplementary",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are missing harm collection, discontinuation, and completeness verified?",
      "application_exception": "Do not turn unread or unreported information into certification that no events occurred.",
      "criterion": "Retain safety-record limitations separately.",
      "basis": "M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation / M19 §19.1.2–19.2.4; detailed discrimination is a Chamgap design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original collection and flow records are provided, distinguish reported events from the scope of omissions."
    },
    {
      "item_id": "N36",
      "question_type": "Harm information",
      "question": "Is independent replication of harm signals verified?",
      "needed": "Unique harm reports and cases, shared populations and recitations, and matching exposures",
      "role": "Supplementary",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Is independent replication of harm signals verified?",
      "application_exception": "Do not sum the same nights, conditions, sibling tables, or material slots as separate harm replications.",
      "criterion": "Do not generate undetermined replication counts.",
      "basis": "M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap designs / M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort and outcome connections are Chamgap adaptations",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If related original lists are provided, distinguish the same events from records of different families."
    },
    {
      "item_id": "N37",
      "question_type": "Harm information",
      "question": "What are the safety and inference limits beyond the short measurement study?",
      "needed": "Direct long-term, rare-harm, and population-specific safety materials and suitable follow-up",
      "role": "Supplementary",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: What are the safety and inference limits beyond the short measurement study?",
      "application_exception": "Do not create a new safety grade, causal certification, or device or sleep-treatment use instructions.",
      "criterion": "Retain the original Unknown status and gaps in extending safety claims.",
      "basis": "M19 §19.1.2–19.2.4; Chamgap adaptation / Chamgap's own interpretation boundary. M19 principles are referenced; no official causality tool was executed / M19 §19.1.2–19.2.4; Chamgap adaptation",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If direct materials are provided, distinguish the one-night measurement study from separate safety scopes."
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "What were the funding, sponsorship, and institutional roles?",
      "needed": "Original support and roles, data access, contracts, and declarations",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: What were the funding, sponsorship, and institutional roles?",
      "application_exception": "Do not promote public or university support or the parent's I2 into current certification of independence.",
      "criterion": "Preserve original support and gaps in roles together.",
      "basis": "CHAMGAP's own independence and attribution conditions. Official methodological sections used in this pilot do not guarantee every detail of this item / M04 §4.6.1–4.6.2, M15 §15.3.1; our own application",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original declarations are provided, distinguish supporting institutions from actual operational roles."
    },
    {
      "item_id": "N39",
      "question_type": "Evidence condition",
      "question": "What were author disclosures, bed and motor provision, and manufacturer roles?",
      "needed": "Author declarations, device provision, and manufacturer roles in design, analysis, and manuscripts",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: What were author disclosures, bed and motor provision, and manufacturer roles?",
      "application_exception": "Do not turn historical non-reporting into certification that there were no device or manufacturer relationships.",
      "criterion": "Distinguish historical declarations and non-reporting from current gaps in external comparison.",
      "basis": "Chamgap's own independence and attribution conditions. The official method sections used in this pilot do not endorse all of these detailed items / M04 §4.5, §4.6.3; limitations in the current material conversion concern review scope and Chamgap design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If original declarations or provision records are provided, distinguish historical non-reporting from actual roles."
    },
    {
      "item_id": "N40",
      "question_type": "Evidence condition",
      "question": "Are the historical review date, corrections, languages, empty values, and current production distinguished?",
      "needed": "Original dates, corrections and retractions, languages and empty values, and current reading scope",
      "role": "Required",
      "role_reason": "Required to record the original information and gaps for this question as an individual condition: Are the historical review date, corrections, languages, empty values, and current production distinguished?",
      "application_exception": "Do not borrow the historical review date or cross-checks as a current clinical verification date, or use an empty array to certify absence of all corrections.",
      "criterion": "Preserve the original history together with current production and incomplete original content review.",
      "basis": "M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design / M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are our own design",
      "condition_origin": "Production based on original materials; existing content review remains incomplete",
      "proposed_research": "If actual update materials are provided, separate the complete original version from a new correction event."
    }
  ]
}