# Didgeridoo training × replacement for standard OSA therapy

Verdict 2991 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-09-07  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-16

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: The original trial records 25 adults with moderate OSA, BMI below 30 and AHI 15–30/h, all completing follow-up. Population, denominators and baseline therapy for a direct treatment-replacement comparison are unlinked. This is not generalized to all OSA patients or severities.
- Ingredient, formulation and route: A structured didgeridoo lesson/home-practice program. This is not converted into a specific instrument-brand effect or equivalent effects from all playing/breathing training. Components, contact, individual actual practice and adherence are unverified. No new playing/breathing methods or procedures are created.
- Dose: Original mean 5.9 days weekly, 25.3 minutes per session and approximately 25 minutes in the intervention name are preserved only as study exposure. Plans, individual distributions, discontinuation and adherence details are unverified. Means do not become identical exposure for everyone or a recommended schedule; total time, frequency and individual intensity are not newly converted.
- Comparator: A four-month wait-list control. Contact, expectation differences and concurrent-treatment details are unverified. This is not converted into direct comparisons, equivalence or treatment-replacement effects versus standard CPAP, oral appliances, other instruments or equal-contact sham.
- Measured outcome: The selected question is replacement for standard OSA therapy, with original grade '?' and note 'No direct comparison with standard therapy was performed.' Existing ESS, AHI, PSQI and bed-partner results are separate endpoints of a wait-list trial. Direct replacement estimands, hypotheses, noninferiority margins and clinical outcomes are unlinked. Original signals are not converted into equivalence, cure, successful replacement or zero effect.
- Duration: The original four-month trial with all 25 completing did not test long-term complication prevention, sustained replacement or safety of stopping established treatment. Short-term symptom/sleep-study signals are distinguished from the long-term clinical question of replacing standard therapy.
- Questions outside this scope: Mixing ESS points, AHI/h, PSQI and bed-partner assessment as the same unit, respondent, endpoint or cure rate; Converting wait-list ESS/AHI signals or alternative treatment in paper/registration titles into direct comparisons, equivalence, noninferiority or successful replacement versus CPAP/oral appliances; Filling arm n, every endpoint denominator or ITT from all 25 completing, or adding paper/registration/two subclaim sheets as independent trials/participants; Inheriting retrospective registration or original historical checks as prerecruitment plans, current external reading or completed clinical review; Extending parent C50, Good and axes into subclaim scores, all BMIs/severities, long-term clinical effects or safety; Creating new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions; Converting the original '?' for untested replacement into a new D grade, zero effect, established failure, cure or treatment recommendation

## Checklist items

### N01 · What is the original grade for the selected treatment-replacement question?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The selected original subclaim is 'Replacement for standard OSA therapy', with grade '?' and note 'No direct comparison with standard therapy was performed.' Parent C50 and sleepiness C do not fill the grade or score for this question.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Subclaim score, status and axes are absent from the original. Direct evidence for replacing standard therapy is unlinked.
- Required materials and conditions: Selected wording, note and grade versus parent efficacy signals
- Materials to obtain first: Subclaim score, status and axes are absent from the original. Direct evidence for replacing standard therapy is unlinked.
- Further research: Material needed: Subclaim score, status and axes are absent from the original. Direct evidence for replacing standard therapy is unlinked. This records needed materials; no new research was executed.
- Conditions for verification: Material for Selected wording, note and grade versus parent efficacy signals must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Selected wording, note and grade versus parent efficacy signals with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02

### N02 · The actual comparator was a wait list

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The existing trial compared didgeridoo lessons/home practice with a wait list over four months. Wait-list results are not converted into direct comparisons with CPAP or oral appliances.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Direct-comparison design, interventions, denominators and original results for standard therapy are unlinked.
- Required materials and conditions: Agreement for a direct comparison with standard therapy
- Materials to obtain first: Direct-comparison design, interventions, denominators and original results for standard therapy are unlinked.
- Further research: Material needed: Direct-comparison design, interventions, denominators and original results for standard therapy are unlinked. This records needed materials; no new research was executed.
- Conditions for verification: Material for Agreement for a direct comparison with standard therapy must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Agreement for a direct comparison with standard therapy with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N03 · Standard-therapy comparison and noninferiority

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The original states that noninferiority or replacement versus standard therapies such as CPAP or oral appliances was not tested. Symptom significance is not transferred into proof of equivalence or noninferiority.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Prior comparative hypotheses, noninferiority margins, testing plans and direct estimands are unlinked.
- Required materials and conditions: Direct comparison, prior hypotheses and noninferiority/equivalence agreement
- Materials to obtain first: Prior comparative hypotheses, noninferiority margins, testing plans and direct estimands are unlinked.
- Further research: Material needed: Prior comparative hypotheses, noninferiority margins, testing plans and direct estimands are unlinked. This records needed materials; no new research was executed.
- Conditions for verification: Material for Direct comparison, prior hypotheses and noninferiority/equivalence agreement must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Direct comparison, prior hypotheses and noninferiority/equivalence agreement with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02

### N04 · Narrow eligibility in the existing trial

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The existing trial involved 25 adults with moderate OSA, BMI below 30 and AHI 15–30/h. It is not extended to replacement for every population or severity requiring standard therapy.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Eligibility, baseline therapy, severity, risk and denominators corresponding to a replacement comparison are unlinked.
- Required materials and conditions: Direct-comparison population, diagnosis, severity and denominators
- Materials to obtain first: Eligibility, baseline therapy, severity, risk and denominators corresponding to a replacement comparison are unlinked.
- Further research: Material needed: Eligibility, baseline therapy, severity, risk and denominators corresponding to a replacement comparison are unlinked. This records needed materials; no new research was executed.
- Conditions for verification: Material for Direct-comparison population, diagnosis, severity and denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Direct-comparison population, diagnosis, severity and denominators with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N05 · Structured program and brand generalization

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The existing evidence concerns a lesson/home-practice program rather than a specific brand. General instrument playing, breathing activities and other programs are not treated as the same replacement intervention.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Program components and exposure/adherence in direct comparisons with standard therapy are unlinked.
- Required materials and conditions: Existing program, actual exposure and comparator intervention
- Materials to obtain first: Program components and exposure/adherence in direct comparisons with standard therapy are unlinked.
- Further research: Material needed: Program components and exposure/adherence in direct comparisons with standard therapy are unlinked. This records needed materials; no new research was executed.
- Conditions for verification: Material for Existing program, actual exposure and comparator intervention must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Existing program, actual exposure and comparator intervention with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N06 · Mean exposure and absence of a replacement regimen

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Mean 5.9 days per week and 25.3 minutes per session are original study records. They are not used as a recommended duration, training prescription or dose for replacing standard therapy.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Individual adherence, exposure distributions and actual use conditions in direct comparisons are unverified.
- Required materials and conditions: Study means, distributions and direct-comparison exposure
- Materials to obtain first: Individual adherence, exposure distributions and actual use conditions in direct comparisons are unverified.
- Further research: Material needed: Individual adherence, exposure distributions and actual use conditions in direct comparisons are unverified. This records needed materials; no new research was executed.
- Conditions for verification: Material for Study means, distributions and direct-comparison exposure must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Study means, distributions and direct-comparison exposure with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N07 · The ESS signal is a wait-list result

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: ESS −3.0 points (95% CI −5.7 to −0.3, P=.03) is the original result versus a wait list. It is not transferred into a difference versus standard therapy, equivalent effects or successful replacement.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: ESS effects versus standard therapy, denominators, CIs and prior agreements are unlinked.
- Required materials and conditions: Sleepiness estimand, directness and units
- Materials to obtain first: ESS effects versus standard therapy, denominators, CIs and prior agreements are unlinked.
- Further research: Material needed: ESS effects versus standard therapy, denominators, CIs and prior agreements are unlinked. This records needed materials; no new research was executed.
- Conditions for verification: Material for Sleepiness estimand, directness and units must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Sleepiness estimand, directness and units with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N08 · The AHI signal and the boundary of replacement

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: AHI −6.2/h (−12.3 to −0.1, P=.05) is a separate signal from the existing wait-list comparison. It is not used as normalization, cure, equal effects to standard therapy or elimination of long-term risk.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: AHI from direct treatment comparisons, normalization/response criteria and long-term clinical endpoints are unlinked.
- Required materials and conditions: Objective measure, standard-therapy comparison and clinical outcomes
- Materials to obtain first: AHI from direct treatment comparisons, normalization/response criteria and long-term clinical endpoints are unlinked.
- Further research: Material needed: AHI from direct treatment comparisons, normalization/response criteria and long-term clinical endpoints are unlinked. This records needed materials; no new research was executed.
- Conditions for verification: Material for Objective measure, standard-therapy comparison and clinical outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Objective measure, standard-therapy comparison and clinical outcomes with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N09 · Nonsignificant PSQI and the full results

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The existing PSQI −0.7 points (−2.1 to 0.6, P=.27) was null. ESS/AHI signals do not create improved overall sleep quality or success on all replacement-related endpoints.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Overall sleep/symptom results, endpoint hierarchy and denominators in direct comparisons are unlinked.
- Required materials and conditions: Discordant efficacy endpoints and denominators
- Materials to obtain first: Overall sleep/symptom results, endpoint hierarchy and denominators in direct comparisons are unlinked.
- Further research: Material needed: Overall sleep/symptom results, endpoint hierarchy and denominators in direct comparisons are unlinked. This records needed materials; no new research was executed.
- Conditions for verification: Material for Discordant efficacy endpoints and denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Discordant efficacy endpoints and denominators with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N10 · Attribution of subjective bed-partner assessment

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The original bed-partner sleep-disturbance result of −2.8 points is subjective. It is not converted into patient ESS, objective AHI or direct confirmation of replacement for standard therapy.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Respondent denominators, scale, exact CI/P and the replacement-comparison agreement are unverified.
- Required materials and conditions: Respondents, scale, denominators and separation from replacement outcomes
- Materials to obtain first: Respondent denominators, scale, exact CI/P and the replacement-comparison agreement are unverified.
- Further research: Material needed: Respondent denominators, scale, exact CI/P and the replacement-comparison agreement are unverified. This records needed materials; no new research was executed.
- Conditions for verification: Material for Respondents, scale, denominators and separation from replacement outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Respondents, scale, denominators and separation from replacement outcomes with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N11 · A prior estimand for the replacement question

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The original material contains symptom/test signals from a trial that did not test replacement. Prior estimands and analysis agreements versus standard therapy are absent from the current stored summary.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Definition of replacement, comparative endpoints, analysis populations, estimands and observation windows are unlinked.
- Required materials and conditions: Clinical question, endpoints, comparator, units and analysis population
- Materials to obtain first: Definition of replacement, comparative endpoints, analysis populations, estimands and observation windows are unlinked.
- Further research: Material needed: Definition of replacement, comparative endpoints, analysis populations, estimands and observation windows are unlinked. This records needed materials; no new research was executed.
- Conditions for verification: Material for Clinical question, endpoints, comparator, units and analysis population must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Clinical question, endpoints, comparator, units and analysis population with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02

### N12 · Concurrent therapy, rescue therapy and exposure

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The original wait-list comparison is not converted into a detailed agreement for stopping or combining standard therapy. The original states that the trial did not assess safety of arbitrarily stopping established therapy.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Baseline/concurrent therapies, changes, rescue exposure and direct-comparison conditions are unverified.
- Required materials and conditions: Records of existing therapy, additional care and rescue exposure
- Materials to obtain first: Baseline/concurrent therapies, changes, rescue exposure and direct-comparison conditions are unverified.
- Further research: Material needed: Baseline/concurrent therapies, changes, rescue exposure and direct-comparison conditions are unverified. This records needed materials; no new research was executed.
- Conditions for verification: Material for Records of existing therapy, additional care and rescue exposure must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Records of existing therapy, additional care and rescue exposure with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N13 · Allocation, waiting and expectations

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The existing trial used a randomized wait list and participants knew their intervention. An unblinded sleepiness signal does not establish the same bias conditions in comparisons with standard therapy.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Allocation concealment, contact/expectation differences, assessor/analyst masking and direct-comparison conditions are unverified.
- Required materials and conditions: Randomization, concealment, contact and masking
- Materials to obtain first: Allocation concealment, contact/expectation differences, assessor/analyst masking and direct-comparison conditions are unverified.
- Further research: Material needed: Allocation concealment, contact/expectation differences, assessor/analyst masking and direct-comparison conditions are unverified. This records needed materials; no new research was executed.
- Conditions for verification: Material for Randomization, concealment, contact and masking must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Randomization, concealment, contact and masking with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N14 · All 25 completing versus analysis/comparison denominators

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The original record that all 25 completed is preserved. It is not extended to arm n, complete analysis of every endpoint, noninferiority analysis denominators or adequate scale.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Allocation by arm, endpoint analyses, ITT/PP, missingness and separate-comparison denominator/size agreements are unverified.
- Required materials and conditions: Completion, endpoint analysis, missingness and ITT/PP
- Materials to obtain first: Allocation by arm, endpoint analyses, ITT/PP, missingness and separate-comparison denominator/size agreements are unverified.
- Further research: Material needed: Allocation by arm, endpoint analyses, ITT/PP, missingness and separate-comparison denominator/size agreements are unverified. This records needed materials; no new research was executed.
- Conditions for verification: Material for Completion, endpoint analysis, missingness and ITT/PP must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Completion, endpoint analysis, missingness and ITT/PP with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N15 · Retrospective registration and no prior replacement agreement

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The original states that ISRCTN31571714 registration followed recruitment. 'Alternative treatment' in its title is not interpreted as a direct standard-therapy comparison or prior noninferiority agreement.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Prerecruitment replacement hypotheses, comparison plans, exact registration/recruitment dates and change history remain unread.
- Required materials and conditions: Registration dates, hypotheses, changes and prior hierarchy
- Materials to obtain first: Prerecruitment replacement hypotheses, comparison plans, exact registration/recruitment dates and change history remain unread.
- Further research: Material needed: Prerecruitment replacement hypotheses, comparison plans, exact registration/recruitment dates and change history remain unread. This records needed materials; no new research was executed.
- Conditions for verification: Material for Registration dates, hypotheses, changes and prior hierarchy must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Registration dates, hypotheses, changes and prior hierarchy with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02

### N16 · ESS main outcome and hierarchy among multiple results

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The evidence record's four-month ESS main outcome and AHI/PSQI are preserved. This hierarchy is not transferred into a prior first endpoint or success criterion for replacement, or verification of the complete analysis plan.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Prerecruitment plans, analysis models, multiplicity and replacement-related outcome agreements are unverified.
- Required materials and conditions: Preserved main outcome, protocol, SAP and multiplicity
- Materials to obtain first: Prerecruitment plans, analysis models, multiplicity and replacement-related outcome agreements are unverified.
- Further research: Material needed: Prerecruitment plans, analysis models, multiplicity and replacement-related outcome agreements are unverified. This records needed materials; no new research was executed.
- Conditions for verification: Material for Preserved main outcome, protocol, SAP and multiplicity must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Preserved main outcome, protocol, SAP and multiplicity with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02

### N17 · Overlap of paper, registration and two sheets

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: S01 Puhan 2006 and S02 ISRCTN31571714 are paper/registration slots for the same 25-person four-month trial. They are shared by the sleepiness and replacement sheets, not added as new independent trials, participants or replications.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Detailed analysis correspondence between external paper and registration remains unread.
- Required materials and conditions: Reports, registration and relationships within the same population/trial
- Materials to obtain first: Detailed analysis correspondence between external paper and registration remains unread.
- Further research: Material needed: Detailed analysis correspondence between external paper and registration remains unread. This records needed materials; no new research was executed.
- Conditions for verification: Material for Reports, registration and relationships within the same population/trial must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Reports, registration and relationships within the same population/trial with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02

### N18 · Independent material for replacing standard therapy

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The existing original states that there was no independent replication or direct comparison with standard therapy. One trial, multiple endpoints and registration bibliography do not become independent confirmation of replacement.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Direct comparison for the replacement question, its separate replication and family independence are unlinked.
- Required materials and conditions: A separate trial under the same comparison agreement
- Materials to obtain first: Direct comparison for the replacement question, its separate replication and family independence are unlinked.
- Further research: Material needed: Direct comparison for the replacement question, its separate replication and family independence are unlinked. This records needed materials; no new research was executed.
- Conditions for verification: Material for A separate trial under the same comparison agreement must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects A separate trial under the same comparison agreement with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02

### N19 · Four months versus long-term complications and persistence

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The existing four-month assessment did not test long-term complication prevention, sustained effects or long-term replacement for standard therapy. Measure signals are not transferred into long-term clinical events.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Long-term direct comparisons, clinical events and persistence after intervention cessation are unlinked.
- Required materials and conditions: Symptoms, sleep tests and clinical outcomes over time
- Materials to obtain first: Long-term direct comparisons, clinical events and persistence after intervention cessation are unlinked.
- Further research: Material needed: Long-term direct comparisons, clinical events and persistence after intervention cessation are unlinked. This records needed materials; no new research was executed.
- Conditions for verification: Material for Symptoms, sleep tests and clinical outcomes over time must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Symptoms, sleep tests and clinical outcomes over time with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N20 · Generalizing replacement to other populations

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The direct population was selected adults with moderate OSA and BMI below 30. Replacement for standard therapy is not generalized to all OSA patients, other severities or other conditions.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Population-specific direct comparisons, denominators and clinical/safety outcomes are unlinked.
- Required materials and conditions: Direct comparisons in other BMIs, severities, ages and conditions
- Materials to obtain first: Population-specific direct comparisons, denominators and clinical/safety outcomes are unlinked.
- Further research: Material needed: Population-specific direct comparisons, denominators and clinical/safety outcomes are unlinked. This records needed materials; no new research was executed.
- Conditions for verification: Material for Direct comparisons in other BMIs, severities, ages and conditions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Direct comparisons in other BMIs, severities, ages and conditions with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N21 · Support, developers and independence gaps

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Zurich Lung Association/clinical support and a training-developer instructor among the authors are recorded. Support information does not fill replacement evidence or verification of all interests/independence.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Original material on funder roles, instrument/product support, developer-instructor roles, employee authors and COI is unverified.
- Required materials and conditions: Funding, equipment support, developer roles and COI
- Materials to obtain first: Original material on funder roles, instrument/product support, developer-instructor roles, employee authors and COI is unverified.
- Further research: Material needed: Original material on funder roles, instrument/product support, developer-instructor roles, employee authors and COI is unverified. This records needed materials; no new research was executed.
- Conditions for verification: Material for Funding, equipment support, developer roles and COI must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Funding, equipment support, developer roles and COI with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N22 · Existing safety wording and stopping treatment

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Parent safety 'Good' and no reported unexpected adverse reactions/events among 25 people over four months are original wording. The same original states that safety of arbitrarily stopping established OSA treatment was not assessed.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Rare/long-term harms, direct replacement comparisons, stopping risks and arm-specific collection/denominators are unverified.
- Required materials and conditions: Actual event collection, exposure, comparisons, denominators and follow-up
- Materials to obtain first: Rare/long-term harms, direct replacement comparisons, stopping risks and arm-specific collection/denominators are unverified.
- Further research: Material needed: Rare/long-term harms, direct replacement comparisons, stopping risks and arm-specific collection/denominators are unverified. This records needed materials; no new research was executed.
- Conditions for verification: Material for Actual event collection, exposure, comparisons, denominators and follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Actual event collection, exposure, comparisons, denominators and follow-up with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01

### N23 · Distinguishing unknown from null effects or cure

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: The subclaim '?' records that no direct comparison with standard therapy was performed. It is not converted into zero effect, established failure, cure, equivalence, a new D grade or treatment recommendations.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Comparative effects, uncertainty and clinical judgment material for the direct replacement question are unlinked.
- Required materials and conditions: Material separating untested replacement, signals and unknowns
- Materials to obtain first: Comparative effects, uncertainty and clinical judgment material for the direct replacement question are unlinked.
- Further research: Material needed: Comparative effects, uncertainty and clinical judgment material for the direct replacement question are unlinked. This records needed materials; no new research was executed.
- Conditions for verification: Material for Material separating untested replacement, signals and unknowns must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Material separating untested replacement, signals and unknowns with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02

### N24 · Are parent values, subclaim grade and the evidence date separated?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Parent C50, B/P/R1/I1/E+/B2/CX, four false flags and empty override, plus subclaim '?' and note are preserved. Original Korean/English wording, 2026-09-07, an empty corrections array and empty deliberation string are not inherited as the current review date or subclaim score.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Subclaim score, status and axes are absent from the original. New corrections and external original-text comparisons were not performed.
- Required materials and conditions: Parent/subclaim original values and historical dates
- Materials to obtain first: Subclaim score, status and axes are absent from the original. New corrections and external original-text comparisons were not performed.
- Further research: Material needed: Subclaim score, status and axes are absent from the original. New corrections and external original-text comparisons were not performed. This records needed materials; no new research was executed.
- Conditions for verification: Material for Parent/subclaim original values and historical dates must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Parent versus subclaim original values and historical dates with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02

### N25 · Are historical checks the current reading?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Original primary-trial, ISRCTN and effect-size verification is preserved as historical wording. Stored summaries/bibliography were used here; original papers, registration, protocols, SAPs and COI remain unread without access attempts.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: Historical-check details, current external-original acquisition/reading and content review remain incomplete.
- Required materials and conditions: Historical review statements, summary use and external access
- Materials to obtain first: Historical-check details, current external-original acquisition/reading and content review remain incomplete.
- Further research: Material needed: Historical-check details, current external-original acquisition/reading and content review remain incomplete. This records needed materials; no new research was executed.
- Conditions for verification: Material for Historical review statements, summary use and external access must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Historical review wording, summary use and external access with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02

### N26 · Which materials would trigger an update?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- Current findings: Original paper/ISRCTN URLs are retained and actual reading is distinguished as summary read versus external material unread. URL presence alone does not raise verification status.
- Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
- Reason for missing information: External-original acquisition, reading, URL verification and content review are needed. Complete pre-change originals, material/condition versions, separate application and change history must be retained.
- Required materials and conditions: Linking summary reading, unread originals and needed material
- Materials to obtain first: External-original acquisition, reading, URL verification and content review are needed. Complete pre-change originals, material/condition versions, separate application and change history must be retained.
- Further research: Material needed: External-original acquisition, reading, URL verification and content review are needed. Complete pre-change originals, material/condition versions, separate application and change history must be retained. This records needed materials; no new research was executed.
- Conditions for verification: Material for Linking summary reading, unread originals and needed material must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
- Why this condition is needed: This condition connects Links between summary reading, unread external material and further material with replacement for standard OSA therapy, the original wait-list trial, gaps in direct comparison, endpoints, denominators, duration and harms.
- Application exceptions: Preserve original numbers, CIs, P values and study exposure only. Distinguish ESS points from AHI/h, PSQI and subjective bed-partner assessment; waiting from standard care; mean exposure from individual adherence; 25 completers from endpoint denominators; and the same paper/registration. Retrospective registration/historical checks do not become prerecruitment plans or current clinical review. No new arithmetic, effects, CIs, hypothetical numbers, grades, independence certification, playing/breathing methods, training, treatment-replacement or procedure instructions are created.
- Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: S01, S02

## Evidence and sources

### S01

Puhan MA et al. BMJ 2006

[PubMed](https://pubmed.ncbi.nlm.nih.gov/16377643/)

Materials actually read: Stored summaries read; original external papers, registration, protocols, SAPs and COI unread without access attempts  
Findings recorded in the summary: ESS −3.0 points (−5.7 to −0.3); AHI −6.2/h (−12.3 to −0.1); PSQI null  
Record level: Preserved original-paper result summary, containing ESS/AHI/PSQI signals versus a wait list. It is not a direct effect report for replacing standard OSA therapy; arm denominators, exact models and prior replacement agreements are unverified.  
Independent replication: The S01 Puhan 2006 paper and S02 ISRCTN31571714 registration are preserved links to the same 25-person four-month didgeridoo lesson/home-practice versus wait-list trial. ESS, AHI, PSQI, bed-partner endpoints, two subclaim sheets and registration are not added as new independent trials, participants or replications. Detailed originals/registration remain externally unread; confirmed unique-trial, participant and independent-replication totals are unrecorded.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored existing review summary | Preserved copy of the complete parent-verdict stored summary | Stored summary | Summary read | Original PubMed URL, PMID 16377643, PMCID PMC1360393, DOI 10.1136/bmj.38705.470590.55 and same-trial ISRCTN31571714 link are preserved. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred. |
| External paper | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Original PubMed URL, PMID 16377643, PMCID PMC1360393, DOI 10.1136/bmj.38705.470590.55 and same-trial ISRCTN31571714 link are preserved. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred. |
| Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Original PubMed URL, PMID 16377643, PMCID PMC1360393, DOI 10.1136/bmj.38705.470590.55 and same-trial ISRCTN31571714 link are preserved. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred. |
| Protocol | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Original PubMed URL, PMID 16377643, PMCID PMC1360393, DOI 10.1136/bmj.38705.470590.55 and same-trial ISRCTN31571714 link are preserved. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred. |
| Statistical analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Original PubMed URL, PMID 16377643, PMCID PMC1360393, DOI 10.1136/bmj.38705.470590.55 and same-trial ISRCTN31571714 link are preserved. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred. |
| Funding, product-support and COI material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Original PubMed URL, PMID 16377643, PMCID PMC1360393, DOI 10.1136/bmj.38705.470590.55 and same-trial ISRCTN31571714 link are preserved. Identifiers alone do not certify current reading, acquisition, prior plans or condition fulfillment, and new URLs are not inferred. |

### S02

ISRCTN31571714. Didgeridoo playing as alternative treatment for obstructive sleep apnoea syndrome.

[Official source](https://www.isrctn.com/ISRCTN31571714)

Materials actually read: Stored summaries read; original external papers, registration, protocols, SAPs and COI unread without access attempts  
Findings recorded in the summary: The original citation historically states that registration timing and multiple-endpoint descriptions were checked. This does not establish current registration reading or newly verified clinical effects.  
Record level: Historical verification wording in preserved registration bibliography, linked to the same trial. The original statement that registration followed recruitment is retained. Exact recruitment/registration dates, change history, protocol and SAP remain unread; no separate effects, CIs or independent trials are created.  
Independent replication: The S01 Puhan 2006 paper and S02 ISRCTN31571714 registration are preserved links to the same 25-person four-month didgeridoo lesson/home-practice versus wait-list trial. ESS, AHI, PSQI, bed-partner endpoints, two subclaim sheets and registration are not added as new independent trials, participants or replications. Detailed originals/registration remain externally unread; confirmed unique-trial, participant and independent-replication totals are unrecorded.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored existing review summary | Preserved copy of the complete parent-verdict stored summary | Stored summary | Summary read | The original ISRCTN31571714 URL is preserved. It registers the same Puhan 2006, 25-person four-month trial, not separate participants or an effect report. Original post-recruitment registration wording is distinguished from currently unread exact dates/plans. |
| External registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | The original ISRCTN31571714 URL is preserved. It registers the same Puhan 2006, 25-person four-month trial, not separate participants or an effect report. Original post-recruitment registration wording is distinguished from currently unread exact dates/plans. |
| Registration amendment history | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | The original ISRCTN31571714 URL is preserved. It registers the same Puhan 2006, 25-person four-month trial, not separate participants or an effect report. Original post-recruitment registration wording is distinguished from currently unread exact dates/plans. |
| Protocol | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | The original ISRCTN31571714 URL is preserved. It registers the same Puhan 2006, 25-person four-month trial, not separate participants or an effect report. Original post-recruitment registration wording is distinguished from currently unread exact dates/plans. |
| Statistical analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | The original ISRCTN31571714 URL is preserved. It registers the same Puhan 2006, 25-person four-month trial, not separate participants or an effect report. Original post-recruitment registration wording is distinguished from currently unread exact dates/plans. |
| Funding, product-support and COI material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | The original ISRCTN31571714 URL is preserved. It registers the same Puhan 2006, 25-person four-month trial, not separate participants or an effect report. Original post-recruitment registration wording is distinguished from currently unread exact dates/plans. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved method HTML copies; no current method-content re-review or official tool execution
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Preserved method HTML copies; no current method-content re-review or official tool execution

## What the statuses mean

- Met: A state used when required evidence is confirmed after user review. This production does not declare that review complete.
- 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: User review pending.
- 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.

## Change history

2026-10-16 · Public page/materials 1.0. The reader view and materials were prepared from the existing 26 items. No new clinical search, verification-status changes or scoring were performed.