Didgeridoo training × replacement for standard OSA therapy

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhat is the original grade for the selected treatment-replacement question?Required	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. S01 S02	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.	Selected wording, note and grade versus parent efficacy signals	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.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionThe actual comparator was a wait listRequired	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. S01	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.	Agreement for a direct comparison with standard therapy	Material needed: Direct-comparison design, interventions, denominators and original results for standard therapy are unlinked. This records needed materials; no new research was executed.
3	Unverified	Full text not readStored summary read	N03 · Evidence conditionStandard-therapy comparison and noninferiorityRequired	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. S01 S02	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.	Direct comparison, prior hypotheses and noninferiority/equivalence agreement	Material needed: Prior comparative hypotheses, noninferiority margins, testing plans and direct estimands are unlinked. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionNarrow eligibility in the existing trialRequired	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. S01	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.	Direct-comparison population, diagnosis, severity and denominators	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.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionStructured program and brand generalizationRequired	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. S01	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.	Existing program, actual exposure and comparator intervention	Material needed: Program components and exposure/adherence in direct comparisons with standard therapy are unlinked. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionMean exposure and absence of a replacement regimenRequired	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. S01	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.	Study means, distributions and direct-comparison exposure	Material needed: Individual adherence, exposure distributions and actual use conditions in direct comparisons are unverified. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionThe ESS signal is a wait-list resultRequired	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. S01	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.	Sleepiness estimand, directness and units	Material needed: ESS effects versus standard therapy, denominators, CIs and prior agreements are unlinked. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionThe AHI signal and the boundary of replacementRequired	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. S01	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.	Objective measure, standard-therapy comparison and clinical outcomes	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.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionNonsignificant PSQI and the full resultsRequired	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. S01	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.	Discordant efficacy endpoints and denominators	Material needed: Overall sleep/symptom results, endpoint hierarchy and denominators in direct comparisons are unlinked. This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionAttribution of subjective bed-partner assessmentRequired	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. S01	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.	Respondents, scale, denominators and separation from replacement outcomes	Material needed: Respondent denominators, scale, exact CI/P and the replacement-comparison agreement are unverified. This records needed materials; no new research was executed.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionA prior estimand for the replacement questionRequired	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. S01 S02	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.	Clinical question, endpoints, comparator, units and analysis population	Material needed: Definition of replacement, comparative endpoints, analysis populations, estimands and observation windows are unlinked. This records needed materials; no new research was executed.
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionConcurrent therapy, rescue therapy and exposureRequired	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. S01	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.	Records of existing therapy, additional care and rescue exposure	Material needed: Baseline/concurrent therapies, changes, rescue exposure and direct-comparison conditions are unverified. This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionAllocation, waiting and expectationsRequired	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. S01	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.	Randomization, concealment, contact and masking	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.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionAll 25 completing versus analysis/comparison denominatorsRequired	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. S01	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.	Completion, endpoint analysis, missingness and ITT/PP	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.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionRetrospective registration and no prior replacement agreementRequired	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. S01 S02	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.	Registration dates, hypotheses, changes and prior hierarchy	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.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionESS main outcome and hierarchy among multiple resultsRequired	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. S01 S02	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.	Preserved main outcome, protocol, SAP and multiplicity	Material needed: Prerecruitment plans, analysis models, multiplicity and replacement-related outcome agreements are unverified. This records needed materials; no new research was executed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionOverlap of paper, registration and two sheetsRequired	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. S01 S02	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.	Reports, registration and relationships within the same population/trial	Material needed: Detailed analysis correspondence between external paper and registration remains unread. This records needed materials; no new research was executed.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionIndependent material for replacing standard therapyRequired	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. S01 S02	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.	A separate trial under the same comparison agreement	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.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionFour months versus long-term complications and persistenceRequired	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. S01	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.	Symptoms, sleep tests and clinical outcomes over time	Material needed: Long-term direct comparisons, clinical events and persistence after intervention cessation are unlinked. This records needed materials; no new research was executed.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionGeneralizing replacement to other populationsRequired	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. S01	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.	Direct comparisons in other BMIs, severities, ages and conditions	Material needed: Population-specific direct comparisons, denominators and clinical/safety outcomes are unlinked. This records needed materials; no new research was executed.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionSupport, developers and independence gapsRequired	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. S01	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.	Funding, equipment support, developer roles and COI	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.
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionExisting safety wording and stopping treatmentSupplementary	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. S01	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.	Actual event collection, exposure, comparisons, denominators and follow-up	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.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionDistinguishing unknown from null effects or cureRequired	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. S01 S02	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.	Material separating untested replacement, signals and unknowns	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.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre parent values, subclaim grade and the evidence date separated?Required	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. S01 S02	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.	Parent/subclaim original values and historical dates	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.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionAre historical checks the current reading?Required	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. S01 S02	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.	Historical review statements, summary use and external access	Material needed: Historical-check details, current external-original acquisition/reading and content review remain incomplete. This records needed materials; no new research was executed.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionWhich materials would trigger an update?Required	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. S01 S02	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.	Linking summary reading, unread originals and needed material	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.

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26 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-07
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
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

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Puhan MA et al. BMJ 2006

PubMed

Material type: Randomized wait-list controlled trial
Materials actually read: Stored summaries read; original external papers, registration, protocols, SAPs and COI unread without access attempts
Findings recorded in the stored 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.
Study overlap and 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.

Public availability, access and reading status by material
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

Material type: Registration bibliography for the same trial; not a separate clinical-effect report
Materials actually read: Stored summaries read; original external papers, registration, protocols, SAPs and COI unread without access attempts
Findings recorded in the stored 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.
Study overlap and 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.

Public availability, access and reading status by material
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.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

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

Required materials and conditions: Selected wording, note and grade versus parent efficacy signals
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N02 · The actual comparator was a wait list

Required materials and conditions: Agreement for a direct comparison with standard therapy
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N03 · Standard-therapy comparison and noninferiority

Required materials and conditions: Direct comparison, prior hypotheses and noninferiority/equivalence agreement
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N04 · Narrow eligibility in the existing trial

Required materials and conditions: Direct-comparison population, diagnosis, severity and denominators
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N05 · Structured program and brand generalization

Required materials and conditions: Existing program, actual exposure and comparator intervention
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N06 · Mean exposure and absence of a replacement regimen

Required materials and conditions: Study means, distributions and direct-comparison exposure
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N07 · The ESS signal is a wait-list result

Required materials and conditions: Sleepiness estimand, directness and units
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N08 · The AHI signal and the boundary of replacement

Required materials and conditions: Objective measure, standard-therapy comparison and clinical outcomes
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N09 · Nonsignificant PSQI and the full results

Required materials and conditions: Discordant efficacy endpoints and denominators
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N10 · Attribution of subjective bed-partner assessment

Required materials and conditions: Respondents, scale, denominators and separation from replacement outcomes
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N11 · A prior estimand for the replacement question

Required materials and conditions: Clinical question, endpoints, comparator, units and analysis population
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N12 · Concurrent therapy, rescue therapy and exposure

Required materials and conditions: Records of existing therapy, additional care and rescue exposure
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N13 · Allocation, waiting and expectations

Required materials and conditions: Randomization, concealment, contact and masking
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N14 · All 25 completing versus analysis/comparison denominators

Required materials and conditions: Completion, endpoint analysis, missingness and ITT/PP
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N15 · Retrospective registration and no prior replacement agreement

Required materials and conditions: Registration dates, hypotheses, changes and prior hierarchy
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N16 · ESS main outcome and hierarchy among multiple results

Required materials and conditions: Preserved main outcome, protocol, SAP and multiplicity
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N17 · Overlap of paper, registration and two sheets

Required materials and conditions: Reports, registration and relationships within the same population/trial
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N18 · Independent material for replacing standard therapy

Required materials and conditions: A separate trial under the same comparison agreement
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N19 · Four months versus long-term complications and persistence

Required materials and conditions: Symptoms, sleep tests and clinical outcomes over time
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N20 · Generalizing replacement to other populations

Required materials and conditions: Direct comparisons in other BMIs, severities, ages and conditions
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N21 · Support, developers and independence gaps

Required materials and conditions: Funding, equipment support, developer roles and COI
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N22 · Existing safety wording and stopping treatment

Required materials and conditions: Actual event collection, exposure, comparisons, denominators and follow-up
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.
Requirement and applicability: Supplementary
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N23 · Distinguishing unknown from null effects or cure

Required materials and conditions: Material separating untested replacement, signals and unknowns
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

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

Required materials and conditions: Parent/subclaim original values and historical dates
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N25 · Are historical checks the current reading?

Required materials and conditions: Historical review statements, summary use and external access
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N26 · Which materials would trigger an update?

Required materials and conditions: Linking summary reading, unread originals and needed material
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: 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

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Preserved method HTML copies; no current method-content re-review or official tool execution

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: 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/material version 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.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-07) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
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.
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.
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.
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?

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