CHAMGAP

Didgeridoo training × daytime sleepiness in moderate OSA

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Evidence conditionWhich daytime-sleepiness claim is examined?Required
The selected claim is reduced daytime sleepiness in moderate OSA. Original grade C and the ESS between-group difference of −3.0 points in its note are retained. Subclaim score, status and axes are absent; parent C50 does not fill a subclaim score.
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 sleepiness claim, note/grade and parent verdict
Material needed: Separate subclaim score, status and axes are absent from the original. The selected claim and parent verdict must be distinguished. This records needed materials; no new research was executed.
2 Partly verified Full text not readStored summary read N02 · Evidence conditionWhich adults with moderate OSA were studied?Required
The original population is 25 adults with moderate OSA, BMI below 30 and AHI 15–30/h. This is not extended to every BMI, severity, age or sleep-disorder population.
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.
Eligibility, baseline characteristics, diagnosis and arm denominators
Material needed: Exact age, sex, baseline ESS, diagnostic procedures and arm allocation denominators are unverified. This records needed materials; no new research was executed.
3 Partly verified Full text not readStored summary read N03 · Evidence conditionWhich program was studied?Required
The original records a structured didgeridoo lesson/home-practice program. This is not changed into a particular instrument-brand effect or an equivalent effect from all playing/breathing training.
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.
Lessons, home practice, developer and intervention specification
Material needed: Lesson components, contact, individual actual practice and generalizable components are unverified. This records needed materials; no new research was executed.
4 Partly verified Full text not readStored summary read N04 · Evidence conditionDoes average practice describe an individual procedure?Required
Mean 5.9 days weekly, 25.3 minutes per session and approximately 25 minutes in the original intervention name describe study exposure. They are not treated as equal exposure for everyone or recommended procedures, and totals are not newly converted.
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.
Planned exposure, mean actual exposure, distribution and adherence
Material needed: Planned exposure, individual distributions, discontinuation, adherence assessment and ESS by exposure are unverified. This records needed materials; no new research was executed.
5 Partly verified Full text not readStored summary read N05 · Evidence conditionWhat does the wait-list comparison establish?Required
Paper S01 is a randomized wait-list comparison. It is not a direct comparison with standard OSA therapy, another instrument or equal-contact sham.
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.
Control care, contact, expectations and concurrent treatment
Material needed: Detailed wait-list care, contact, expectation differences and concurrent treatment are unverified. This records needed materials; no new research was executed.
6 Partly verified Full text not readStored summary read N06 · Evidence conditionAre randomization and concealment detailed?Required
The S01 design and stored report record random allocation. The summary does not establish sequence generation, allocation concealment or processes before/after recruitment.
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.
Allocation sequence, concealment and recruitment processes
Material needed: Sequence generation, concealment, responsible staff and recruitment/allocation processes are unverified. This records needed materials; no new research was executed.
7 Partly verified Full text not readStored summary read N07 · Evidence conditionIs unblinded symptom assessment distinguished?Required
The stored report states that participants knew their intervention and identifies unblinded subjective symptom assessment as a limitation. Objective AHI does not substitute for ESS masking or control of expectation effects.
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.
Participant, assessor/analyst masking and expectation differences
Material needed: Assessor/analyst masking, contact/expectation differences and their control are unverified. This records needed materials; no new research was executed.
8 Partly verified Full text not readStored summary read N08 · Evidence conditionWhat did ESS assess and when?Required
The S01 main endpoint is the four-month Epworth Sleepiness Scale (ESS) score. AHI/h, PSQI and bed-partner disturbance are different measures.
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.
Scale, assessment window, method and units
Material needed: Scale administration, recall period, assessment timing, standardization and baseline distributions are unverified. This records needed materials; no new research was executed.
9 Partly verified Full text not readStored summary read N09 · Evidence conditionWhat is the original ESS difference, CI and P value?Required
The ESS between-group difference of −3.0 points (95% CI −5.7 to −0.3, P=.03) is preserved. It is not transferred into within-arm change, treatment-replacement differences or cure rates.
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.
Comparative estimate, units, denominators and model
Material needed: Original arm values, exact analysis denominators, model, baseline adjustment and outcome-hierarchy details are unverified. This records needed materials; no new research was executed.
10 Unverified Full text not readStored summary read N10 · Evidence conditionAre ESS importance and individual distributions verified?Required
The stored report describes a symptom signal from one small trial. −3.0 points and statistical significance alone do not establish perceived or clinically important improvement for every participant.
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.
Relevance thresholds, individual changes and uncertainty
Material needed: Prior relevance thresholds, individual distributions, response definitions and persistence are unverified. This records needed materials; no new research was executed.
11 Partly verified Full text not readStored summary read N11 · Evidence conditionDid effects persist after four months?Required
The original study assessed four months. Original statements that long-term complication prevention and standard-treatment replacement were not tested are preserved separately.
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.
Assessment duration, intervention cessation and long-term follow-up
Material needed: ESS persistence beyond four months, post-intervention changes and long-term clinical outcomes have no linked material. This records needed materials; no new research was executed.
12 Partly verified Full text not readStored summary read N12 · Evidence conditionIs AHI a separate result from ESS?Required
The AHI between-group difference of −6.2/h (−12.3 to −0.1, P=.05) is a separate sleep-study result. Its same-direction original signal is preserved without transfer to ESS effects/scores, cure or equivalence to standard therapy.
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.
Distinguishing ESS/AHI definitions, results and units
Material needed: Sleep-study methods, AHI calculation, condition-specific denominators and exact prior analysis plans are unverified. This records needed materials; no new research was executed.
13 Partly verified Full text not readStored summary read N13 · Evidence conditionIs the null PSQI result also retained?Required
PSQI −0.7 points (−2.1 to 0.6, P=.27) is described as null in the original. The sleepiness signal is not transferred to overall sleep-quality improvement, and nonsignificance does not become an exact zero effect.
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.
Endpoint-specific effects, units and uncertainty
Material needed: PSQI procedures, denominators, model and prespecified hierarchy are unverified. This records needed materials; no new research was executed.
14 Partly verified Full text not readStored summary read N14 · Evidence conditionAre the bed-partner respondent and endpoint distinguished?Required
The original describes a −2.8-point improvement in bed-partner sleep disturbance as subjective assessment. It is not transferred to patient ESS, objective AHI or direct replication in an independent trial.
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.
Respondent, scale, endpoint and denominators
Material needed: Bed-partner denominators, scale, exact CIs/P values, masking and prior hierarchy are unverified. This records needed materials; no new research was executed.
15 Partly verified Full text not readStored summary read N15 · Evidence conditionDoes completion by everyone establish every analysis denominator?Required
The original records all 25 participants completing follow-up. This does not automatically fill arm n, complete ESS/AHI/PSQI analyses or ITT/PP status.
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.
Allocation, completion, endpoint analyses and missingness
Material needed: Arm allocation, endpoint analysis denominators, missingness, ITT/PP and exclusion reasons are unverified. This records needed materials; no new research was executed.
16 Unverified Full text not readStored summary read N16 · Evidence conditionAre concurrent treatment, weight and lifestyle changes verified?Required
The comparison is lessons/home practice versus waiting. The summary is not extended to certify control or absence of concurrent OSA therapy, weight changes or lifestyle changes.
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.
Arm-specific concurrent care, exposure and adjustment
Material needed: Concurrent therapy, weight/activity changes, medication, baseline adjustment and adherence are unverified. This records needed materials; no new research was executed.
17 Partly verified Full text not readStored summary read N17 · Evidence conditionWhen was ISRCTN registration made?Required
The preserved registration is ISRCTN31571714; the original records registration after recruitment began. Its identifier/URL does not establish current registration reading or verification of prerecruitment registration.
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 identity, recruitment/registration timing and original records
Material needed: Exact recruitment/registration dates, original registration and change-history details remain unread. This records needed materials; no new research was executed.
18 Partly verified Full text not readStored summary read N18 · Evidence conditionDoes an ESS main endpoint establish the complete prior plan?Required
The original evidence item records four-month ESS as the main endpoint; historical grading describes separation of ESS/AHI/PSQI. In the retrospective-registration context, this is not converted into verified prerecruitment hierarchy or a completely reviewed SAP.
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.
Separating main-endpoint wording, registration, protocol and SAP
Material needed: Prerecruitment ESS hierarchy, protocol, SAP, change history and analysis plans are unverified. This records needed materials; no new research was executed.
19 Unverified Full text not readStored summary read N19 · Evidence conditionAre multiple endpoints and test models distinguished?Required
ESS, AHI, PSQI and subjective bed-partner assessment are different results. Some significant results are not extended to success of all endpoints or prior multiplicity adjustment.
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.
All endpoints, tests, adjustment and multiplicity
Material needed: Test direction, exact models, covariates, multiplicity and prior plans for additional endpoints are unverified. This records needed materials; no new research was executed.
20 Partly verified Full text not readStored summary read N20 · Evidence conditionAre the paper and registration separate trials?Required
The S01 Puhan 2006 paper and S02 ISRCTN31571714 registration are preserved links to the same 25-person four-month trial. Registration is not counted as another sleepiness-effect report, new participants or an independent trial.
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, trial family and population links
Material needed: Detailed original/registration plans and correspondence between analyses remain externally unread. This records needed materials; no new research was executed.
21 Unverified Full text not readStored summary read N21 · Evidence conditionWas the sleepiness effect independently replicated?Required
The stored report states that independent replication was absent. Multiple endpoints, paper/registration and two subclaim sheets from one trial do not become independent replication.
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.
Separate trials with the same population/intervention/comparator
Material needed: Separate replication under the same conditions and actual trial-family independence are unverified. This records needed materials; no new research was executed.
22 Unverified Full text not readStored summary read N22 · Evidence conditionDoes this apply to other BMIs, severities or ages?Required
The direct population is selected adults with BMI below 30 and AHI 15–30/h. The same effects are not generalized to other severities, BMIs, ages or diseases.
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 population-specific material and subgroup plans
Material needed: Population-specific ESS, AHI, safety and prior subgroup plans have no linked material. This records needed materials; no new research was executed.
23 Partly verified Full text not readStored summary read N23 · Evidence conditionDo sleepiness/AHI signals establish replacement of standard therapy?Required
The parent report describes a wait-list signal and states that noninferiority/replacement versus CPAP or oral appliances was not tested. Sleepiness results do not establish equal standard-treatment effects, cure or grounds to stop treatment.
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 standard-treatment comparisons and clinical outcomes
Material needed: Direct standard-treatment comparisons, noninferiority and long-term clinical outcomes have no linked material. This records needed materials; no new research was executed.
24 Partly verified Full text not readStored summary read N24 · Evidence conditionAre funding, the developer-instructor and conflicts distinguished?Required
Original funding records Zurich Lung Association/clinical support and a training developer-instructor among the authors. This is not converted into complete conflict verification or independence certification.
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.
Original support, product, employee/developer and COI records
Material needed: Funding roles, equipment/instrument support, developer-instructor roles, employee authors, COI and analysis/reporting involvement are unverified. This records needed materials; no new research was executed.
25 Partly verified Full text not readStored summary read N25 · Evidence conditionWhat was reported about safety and sample-size limits?Supplementary
The original parent safety label is Good; no unexpected/adverse events were reported in 25 people over four months. This is not extended to absence of rare harms, long-term safety or safety of stopping established treatment.
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.
Harm collection, exposure, arm denominators and follow-up
Material needed: Collection methods, event definitions, arm denominators, rare/long-term harms and treatment-cessation material are unverified. This records needed materials; no new research was executed.
26 Partly verified Full text not readStored summary read N26 · Evidence conditionAre parent values, subclaim grade and the evidence date separated?Required
Parent C50, B/P/R1/I1/E+/B2/CX, four false flags, empty override and subclaim C/note are preserved. Original bilingual wording, 2026-09-07, empty corrections array and empty deliberation string are not inherited as the current review date or a subclaim score.
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.
27 Partly verified Full text not readStored summary read N27 · 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.
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.
28 Partly verified Full text not readStored summary read N28 · 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.
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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28 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 records 25 adults with moderate obstructive sleep apnea (OSA), BMI below 30 and AHI 15–30/h, all completing follow-up. Age, sex, eligibility details, baseline ESS, arm allocation and endpoint analysis denominators are unverified. This is not generalized to all BMIs, severities or ages; completion by everyone does not fill complete analyses for every endpoint.
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 endpoint is four-month Epworth Sleepiness Scale (ESS), with between-group difference −3.0 points (95% CI −5.7 to −0.3, P=.03). AHI −6.2/h (−12.3 to −0.1, P=.05), null PSQI −0.7 points (−2.1 to 0.6, P=.27) and subjective bed-partner assessment −2.8 points are separate. Exact models, denominators and prerecruitment hierarchy are unverified. Units, respondents and endpoints are not mixed; no new effects, CIs or cure rates are created.
Duration
Original four-month assessment and completion by all 25 participants. Boundaries of unverified/untested later ESS persistence, post-intervention change, long-term complication prevention and standard-treatment replacement are retained. Short-term symptom/sleep-study results are not extended to long-term clinical outcomes or safety of stopping established treatment.
Questions outside this scope
Mixing ESS points, AHI/h, PSQI and bed-partner assessment as the same unit, respondent, endpoint or cure rate; Transferring an unblinded wait-list ESS signal into direct comparisons, equivalence, noninferiority or replacement effects 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

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. Selected ESS points are distinguished from AHI/h, PSQI and subjective bed-partner assessment. Arm denominators, exact models and prerecruitment plans are unverified; wait-list results are not transferred to replacement of standard therapy.
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
MaterialPublic availabilityAccess statusActually readNotes
Stored existing review summaryPreserved copy of the complete parent-verdict stored summaryStored summarySummary readOriginal 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 paperOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readOriginal 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 materialOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readOriginal 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.
ProtocolOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readOriginal 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 planOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readOriginal 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 materialOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readOriginal 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
MaterialPublic availabilityAccess statusActually readNotes
Stored existing review summaryPreserved copy of the complete parent-verdict stored summaryStored summarySummary readThe 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 materialOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readThe 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 historyOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readThe 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.
ProtocolOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readThe 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 planOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readThe 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 materialOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readThe 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 · Which daytime-sleepiness claim is examined?
Required materials and conditions
Selected sleepiness claim, note/grade and parent verdict
Conditions for verification
Material for Selected sleepiness claim, note/grade and parent verdict 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 sleepiness claim, note/grade and parent verdict with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Which adults with moderate OSA were studied?
Required materials and conditions
Eligibility, baseline characteristics, diagnosis and arm denominators
Conditions for verification
Material for Eligibility, baseline characteristics, diagnosis and arm 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 Eligibility, baseline characteristics, diagnosis and arm denominators with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Which program was studied?
Required materials and conditions
Lessons, home practice, developer and intervention specification
Conditions for verification
Material for Lessons, home practice, developer and intervention specification 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 Lessons, home practice, developer and intervention specification with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Does average practice describe an individual procedure?
Required materials and conditions
Planned exposure, mean actual exposure, distribution and adherence
Conditions for verification
Material for Planned exposure, mean actual exposure, distribution and adherence 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 Planned exposure, mean actual exposure, distribution and adherence with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · What does the wait-list comparison establish?
Required materials and conditions
Control care, contact, expectations and concurrent treatment
Conditions for verification
Material for Control care, contact, expectations and concurrent treatment 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 Control care, contact, expectations and concurrent treatment with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Are randomization and concealment detailed?
Required materials and conditions
Allocation sequence, concealment and recruitment processes
Conditions for verification
Material for Allocation sequence, concealment and recruitment processes 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 Allocation sequence, concealment and recruitment processes with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Is unblinded symptom assessment distinguished?
Required materials and conditions
Participant, assessor/analyst masking and expectation differences
Conditions for verification
Material for Participant, assessor/analyst masking and expectation differences 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 Participant, assessor/analyst masking and expectation differences with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · What did ESS assess and when?
Required materials and conditions
Scale, assessment window, method and units
Conditions for verification
Material for Scale, assessment window, method 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 Scale, assessment window, method and units with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · What is the original ESS difference, CI and P value?
Required materials and conditions
Comparative estimate, units, denominators and model
Conditions for verification
Material for Comparative estimate, units, denominators and model 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 Comparative estimate, units, denominators and model with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Are ESS importance and individual distributions verified?
Required materials and conditions
Relevance thresholds, individual changes and uncertainty
Conditions for verification
Material for Relevance thresholds, individual changes and uncertainty 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 Relevance thresholds, individual changes and uncertainty with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Did effects persist after four months?
Required materials and conditions
Assessment duration, intervention cessation and long-term follow-up
Conditions for verification
Material for Assessment duration, intervention cessation and long-term 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
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 Assessment duration, intervention cessation and long-term follow-up with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Is AHI a separate result from ESS?
Required materials and conditions
Distinguishing ESS/AHI definitions, results and units
Conditions for verification
Material for Distinguishing ESS/AHI definitions, results 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 Distinguishing ESS/AHI definitions, results and units with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Is the null PSQI result also retained?
Required materials and conditions
Endpoint-specific effects, units and uncertainty
Conditions for verification
Material for Endpoint-specific effects, units and uncertainty 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 Endpoint-specific effects, units and uncertainty with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Are the bed-partner respondent and endpoint distinguished?
Required materials and conditions
Respondent, scale, endpoint and denominators
Conditions for verification
Material for Respondent, scale, endpoint 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 Respondent, scale, endpoint and denominators with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Does completion by everyone establish every analysis denominator?
Required materials and conditions
Allocation, completion, endpoint analyses and missingness
Conditions for verification
Material for Allocation, completion, endpoint analyses and missingness 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 Allocation, completion, endpoint analyses and missingness with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Are concurrent treatment, weight and lifestyle changes verified?
Required materials and conditions
Arm-specific concurrent care, exposure and adjustment
Conditions for verification
Material for Arm-specific concurrent care, exposure and adjustment 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 Arm-specific concurrent care, exposure and adjustment with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · When was ISRCTN registration made?
Required materials and conditions
Registration identity, recruitment/registration timing and original records
Conditions for verification
Material for Registration identity, recruitment/registration timing and original records 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 identity, recruitment/registration timing and original records with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Does an ESS main endpoint establish the complete prior plan?
Required materials and conditions
Separating main-endpoint wording, registration, protocol and SAP
Conditions for verification
Material for Separating main-endpoint wording, registration, protocol and SAP 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 Separating main-endpoint wording, registration, protocol and SAP with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Are multiple endpoints and test models distinguished?
Required materials and conditions
All endpoints, tests, adjustment and multiplicity
Conditions for verification
Material for All endpoints, tests, adjustment 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 All endpoints, tests, adjustment and multiplicity with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Are the paper and registration separate trials?
Required materials and conditions
Reports, registration, trial family and population links
Conditions for verification
Material for Reports, registration, trial family and population links 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, trial family and population links with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Was the sleepiness effect independently replicated?
Required materials and conditions
Separate trials with the same population/intervention/comparator
Conditions for verification
Material for Separate trials with the same population/intervention/comparator 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 Separate trials with the same population/intervention/comparator with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Does this apply to other BMIs, severities or ages?
Required materials and conditions
Direct population-specific material and subgroup plans
Conditions for verification
Material for Direct population-specific material and subgroup plans 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 population-specific material and subgroup plans with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Do sleepiness/AHI signals establish replacement of standard therapy?
Required materials and conditions
Direct standard-treatment comparisons and clinical outcomes
Conditions for verification
Material for Direct standard-treatment comparisons 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 Direct standard-treatment comparisons and clinical outcomes with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 funding, the developer-instructor and conflicts distinguished?
Required materials and conditions
Original support, product, employee/developer and COI records
Conditions for verification
Material for Original support, product, employee/developer and COI records 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 Original support, product, employee/developer and COI records with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · What was reported about safety and sample-size limits?
Required materials and conditions
Harm collection, exposure, arm denominators and follow-up
Conditions for verification
Material for Harm collection, exposure, arm 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 Harm collection, exposure, arm denominators and follow-up with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · 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/subclaim original values and historical dates with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N27 · 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 statements, summary use and external access with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N28 · 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 Linking summary reading, unread originals and needed material with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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

Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state 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 · Which daytime-sleepiness claim is examined?

Current findings
The selected claim is reduced daytime sleepiness in moderate OSA. Original grade C and the ESS between-group difference of −3.0 points in its note are retained. Subclaim score, status and axes are absent; parent C50 does not fill a 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
Separate subclaim score, status and axes are absent from the original. The selected claim and parent verdict must be distinguished.
Required materials and conditions
Selected sleepiness claim, note/grade and parent verdict
Materials to obtain first
Separate subclaim score, status and axes are absent from the original. The selected claim and parent verdict must be distinguished.
Further research
Material needed: Separate subclaim score, status and axes are absent from the original. The selected claim and parent verdict must be distinguished. 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 sleepiness claim, note/grade and parent verdict 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 sleepiness claim, note/grade and parent verdict with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Which adults with moderate OSA were studied?

Current findings
The original population is 25 adults with moderate OSA, BMI below 30 and AHI 15–30/h. This is not extended to every BMI, severity, age or sleep-disorder population.
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
Exact age, sex, baseline ESS, diagnostic procedures and arm allocation denominators are unverified.
Required materials and conditions
Eligibility, baseline characteristics, diagnosis and arm denominators
Materials to obtain first
Exact age, sex, baseline ESS, diagnostic procedures and arm allocation denominators are unverified.
Further research
Material needed: Exact age, sex, baseline ESS, diagnostic procedures and arm allocation 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 Eligibility, baseline characteristics, diagnosis and arm 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 Eligibility, baseline characteristics, diagnosis and arm denominators with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Which program was studied?

Current findings
The original records a structured didgeridoo lesson/home-practice program. This is not changed into a particular instrument-brand effect or an equivalent effect from all playing/breathing training.
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
Lesson components, contact, individual actual practice and generalizable components are unverified.
Required materials and conditions
Lessons, home practice, developer and intervention specification
Materials to obtain first
Lesson components, contact, individual actual practice and generalizable components are unverified.
Further research
Material needed: Lesson components, contact, individual actual practice and generalizable components 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 Lessons, home practice, developer and intervention specification 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 Lessons, home practice, developer and intervention specification with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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

N04 · Does average practice describe an individual procedure?

Current findings
Mean 5.9 days weekly, 25.3 minutes per session and approximately 25 minutes in the original intervention name describe study exposure. They are not treated as equal exposure for everyone or recommended procedures, and totals are not newly converted.
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
Planned exposure, individual distributions, discontinuation, adherence assessment and ESS by exposure are unverified.
Required materials and conditions
Planned exposure, mean actual exposure, distribution and adherence
Materials to obtain first
Planned exposure, individual distributions, discontinuation, adherence assessment and ESS by exposure are unverified.
Further research
Material needed: Planned exposure, individual distributions, discontinuation, adherence assessment and ESS by exposure 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 Planned exposure, mean actual exposure, distribution and adherence 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 Planned exposure, mean actual exposure, distribution and adherence with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · What does the wait-list comparison establish?

Current findings
Paper S01 is a randomized wait-list comparison. It is not a direct comparison with standard OSA therapy, another instrument or equal-contact sham.
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 wait-list care, contact, expectation differences and concurrent treatment are unverified.
Required materials and conditions
Control care, contact, expectations and concurrent treatment
Materials to obtain first
Detailed wait-list care, contact, expectation differences and concurrent treatment are unverified.
Further research
Material needed: Detailed wait-list care, contact, expectation differences and concurrent treatment 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 Control care, contact, expectations and concurrent treatment 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 Control care, contact, expectations and concurrent treatment with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Are randomization and concealment detailed?

Current findings
The S01 design and stored report record random allocation. The summary does not establish sequence generation, allocation concealment or processes before/after recruitment.
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
Sequence generation, concealment, responsible staff and recruitment/allocation processes are unverified.
Required materials and conditions
Allocation sequence, concealment and recruitment processes
Materials to obtain first
Sequence generation, concealment, responsible staff and recruitment/allocation processes are unverified.
Further research
Material needed: Sequence generation, concealment, responsible staff and recruitment/allocation processes 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 Allocation sequence, concealment and recruitment processes 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 Allocation sequence, concealment and recruitment processes with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Is unblinded symptom assessment distinguished?

Current findings
The stored report states that participants knew their intervention and identifies unblinded subjective symptom assessment as a limitation. Objective AHI does not substitute for ESS masking or control of expectation effects.
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
Assessor/analyst masking, contact/expectation differences and their control are unverified.
Required materials and conditions
Participant, assessor/analyst masking and expectation differences
Materials to obtain first
Assessor/analyst masking, contact/expectation differences and their control are unverified.
Further research
Material needed: Assessor/analyst masking, contact/expectation differences and their control 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 Participant, assessor/analyst masking and expectation differences 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 Participant, assessor/analyst masking and expectation differences with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · What did ESS assess and when?

Current findings
The S01 main endpoint is the four-month Epworth Sleepiness Scale (ESS) score. AHI/h, PSQI and bed-partner disturbance are different measures.
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
Scale administration, recall period, assessment timing, standardization and baseline distributions are unverified.
Required materials and conditions
Scale, assessment window, method and units
Materials to obtain first
Scale administration, recall period, assessment timing, standardization and baseline distributions are unverified.
Further research
Material needed: Scale administration, recall period, assessment timing, standardization and baseline distributions 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 Scale, assessment window, method 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 Scale, assessment window, method and units with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · What is the original ESS difference, CI and P value?

Current findings
The ESS between-group difference of −3.0 points (95% CI −5.7 to −0.3, P=.03) is preserved. It is not transferred into within-arm change, treatment-replacement differences or cure rates.
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 arm values, exact analysis denominators, model, baseline adjustment and outcome-hierarchy details are unverified.
Required materials and conditions
Comparative estimate, units, denominators and model
Materials to obtain first
Original arm values, exact analysis denominators, model, baseline adjustment and outcome-hierarchy details are unverified.
Further research
Material needed: Original arm values, exact analysis denominators, model, baseline adjustment and outcome-hierarchy details 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 Comparative estimate, units, denominators and model 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 Comparative estimate, units, denominators and model with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Are ESS importance and individual distributions verified?

Current findings
The stored report describes a symptom signal from one small trial. −3.0 points and statistical significance alone do not establish perceived or clinically important improvement for every participant.
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 relevance thresholds, individual distributions, response definitions and persistence are unverified.
Required materials and conditions
Relevance thresholds, individual changes and uncertainty
Materials to obtain first
Prior relevance thresholds, individual distributions, response definitions and persistence are unverified.
Further research
Material needed: Prior relevance thresholds, individual distributions, response definitions and persistence 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 Relevance thresholds, individual changes and uncertainty 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 Relevance thresholds, individual changes and uncertainty with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Did effects persist after four months?

Current findings
The original study assessed four months. Original statements that long-term complication prevention and standard-treatment replacement were not tested are preserved separately.
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 persistence beyond four months, post-intervention changes and long-term clinical outcomes have no linked material.
Required materials and conditions
Assessment duration, intervention cessation and long-term follow-up
Materials to obtain first
ESS persistence beyond four months, post-intervention changes and long-term clinical outcomes have no linked material.
Further research
Material needed: ESS persistence beyond four months, post-intervention changes and long-term clinical outcomes have no linked material. 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 Assessment duration, intervention cessation and long-term 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 Assessment duration, intervention cessation and long-term follow-up with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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

N12 · Is AHI a separate result from ESS?

Current findings
The AHI between-group difference of −6.2/h (−12.3 to −0.1, P=.05) is a separate sleep-study result. Its same-direction original signal is preserved without transfer to ESS effects/scores, cure or equivalence to 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
Sleep-study methods, AHI calculation, condition-specific denominators and exact prior analysis plans are unverified.
Required materials and conditions
Distinguishing ESS/AHI definitions, results and units
Materials to obtain first
Sleep-study methods, AHI calculation, condition-specific denominators and exact prior analysis plans are unverified.
Further research
Material needed: Sleep-study methods, AHI calculation, condition-specific denominators and exact prior analysis plans 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 Distinguishing ESS/AHI definitions, results 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 Distinguishing ESS/AHI definitions, results and units with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Is the null PSQI result also retained?

Current findings
PSQI −0.7 points (−2.1 to 0.6, P=.27) is described as null in the original. The sleepiness signal is not transferred to overall sleep-quality improvement, and nonsignificance does not become an exact zero effect.
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
PSQI procedures, denominators, model and prespecified hierarchy are unverified.
Required materials and conditions
Endpoint-specific effects, units and uncertainty
Materials to obtain first
PSQI procedures, denominators, model and prespecified hierarchy are unverified.
Further research
Material needed: PSQI procedures, denominators, model and prespecified hierarchy 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 Endpoint-specific effects, units and uncertainty 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 Endpoint-specific effects, units and uncertainty with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Are the bed-partner respondent and endpoint distinguished?

Current findings
The original describes a −2.8-point improvement in bed-partner sleep disturbance as subjective assessment. It is not transferred to patient ESS, objective AHI or direct replication in an independent trial.
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
Bed-partner denominators, scale, exact CIs/P values, masking and prior hierarchy are unverified.
Required materials and conditions
Respondent, scale, endpoint and denominators
Materials to obtain first
Bed-partner denominators, scale, exact CIs/P values, masking and prior hierarchy are unverified.
Further research
Material needed: Bed-partner denominators, scale, exact CIs/P values, masking and prior hierarchy 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 Respondent, scale, endpoint 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 Respondent, scale, endpoint and denominators with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Does completion by everyone establish every analysis denominator?

Current findings
The original records all 25 participants completing follow-up. This does not automatically fill arm n, complete ESS/AHI/PSQI analyses or ITT/PP 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
Arm allocation, endpoint analysis denominators, missingness, ITT/PP and exclusion reasons are unverified.
Required materials and conditions
Allocation, completion, endpoint analyses and missingness
Materials to obtain first
Arm allocation, endpoint analysis denominators, missingness, ITT/PP and exclusion reasons are unverified.
Further research
Material needed: Arm allocation, endpoint analysis denominators, missingness, ITT/PP and exclusion reasons 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 Allocation, completion, endpoint analyses and missingness 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 Allocation, completion, endpoint analyses and missingness with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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

N16 · Are concurrent treatment, weight and lifestyle changes verified?

Current findings
The comparison is lessons/home practice versus waiting. The summary is not extended to certify control or absence of concurrent OSA therapy, weight changes or lifestyle changes.
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
Concurrent therapy, weight/activity changes, medication, baseline adjustment and adherence are unverified.
Required materials and conditions
Arm-specific concurrent care, exposure and adjustment
Materials to obtain first
Concurrent therapy, weight/activity changes, medication, baseline adjustment and adherence are unverified.
Further research
Material needed: Concurrent therapy, weight/activity changes, medication, baseline adjustment and adherence 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 Arm-specific concurrent care, exposure and adjustment 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 Arm-specific concurrent care, exposure and adjustment with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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

N17 · When was ISRCTN registration made?

Current findings
The preserved registration is ISRCTN31571714; the original records registration after recruitment began. Its identifier/URL does not establish current registration reading or verification of prerecruitment registration.
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
Exact recruitment/registration dates, original registration and change-history details remain unread.
Required materials and conditions
Registration identity, recruitment/registration timing and original records
Materials to obtain first
Exact recruitment/registration dates, original registration and change-history details remain unread.
Further research
Material needed: Exact recruitment/registration dates, original registration and change-history details 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 identity, recruitment/registration timing and original records 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 identity, recruitment/registration timing and original records with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Does an ESS main endpoint establish the complete prior plan?

Current findings
The original evidence item records four-month ESS as the main endpoint; historical grading describes separation of ESS/AHI/PSQI. In the retrospective-registration context, this is not converted into verified prerecruitment hierarchy or a completely reviewed SAP.
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 ESS hierarchy, protocol, SAP, change history and analysis plans are unverified.
Required materials and conditions
Separating main-endpoint wording, registration, protocol and SAP
Materials to obtain first
Prerecruitment ESS hierarchy, protocol, SAP, change history and analysis plans are unverified.
Further research
Material needed: Prerecruitment ESS hierarchy, protocol, SAP, change history and analysis plans 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 Separating main-endpoint wording, registration, protocol and SAP 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 Separating main-endpoint wording, registration, protocol and SAP with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Are multiple endpoints and test models distinguished?

Current findings
ESS, AHI, PSQI and subjective bed-partner assessment are different results. Some significant results are not extended to success of all endpoints or prior multiplicity adjustment.
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
Test direction, exact models, covariates, multiplicity and prior plans for additional endpoints are unverified.
Required materials and conditions
All endpoints, tests, adjustment and multiplicity
Materials to obtain first
Test direction, exact models, covariates, multiplicity and prior plans for additional endpoints are unverified.
Further research
Material needed: Test direction, exact models, covariates, multiplicity and prior plans for additional endpoints 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 All endpoints, tests, adjustment 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 All endpoints, tests, adjustment and multiplicity with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Are the paper and registration separate trials?

Current findings
The S01 Puhan 2006 paper and S02 ISRCTN31571714 registration are preserved links to the same 25-person four-month trial. Registration is not counted as another sleepiness-effect report, new participants or an independent trial.
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 original/registration plans and correspondence between analyses remain externally unread.
Required materials and conditions
Reports, registration, trial family and population links
Materials to obtain first
Detailed original/registration plans and correspondence between analyses remain externally unread.
Further research
Material needed: Detailed original/registration plans and correspondence between analyses remain externally 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, trial family and population links 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, trial family and population links with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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

N21 · Was the sleepiness effect independently replicated?

Current findings
The stored report states that independent replication was absent. Multiple endpoints, paper/registration and two subclaim sheets from one trial do not become independent replication.
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
Separate replication under the same conditions and actual trial-family independence are unverified.
Required materials and conditions
Separate trials with the same population/intervention/comparator
Materials to obtain first
Separate replication under the same conditions and actual trial-family independence are unverified.
Further research
Material needed: Separate replication under the same conditions and actual trial-family independence 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 Separate trials with the same population/intervention/comparator 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 Separate trials with the same population/intervention/comparator with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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

N22 · Does this apply to other BMIs, severities or ages?

Current findings
The direct population is selected adults with BMI below 30 and AHI 15–30/h. The same effects are not generalized to other severities, BMIs, ages or diseases.
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 ESS, AHI, safety and prior subgroup plans have no linked material.
Required materials and conditions
Direct population-specific material and subgroup plans
Materials to obtain first
Population-specific ESS, AHI, safety and prior subgroup plans have no linked material.
Further research
Material needed: Population-specific ESS, AHI, safety and prior subgroup plans have no linked material. 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 population-specific material and subgroup plans 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 population-specific material and subgroup plans with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 · Do sleepiness/AHI signals establish replacement of standard therapy?

Current findings
The parent report describes a wait-list signal and states that noninferiority/replacement versus CPAP or oral appliances was not tested. Sleepiness results do not establish equal standard-treatment effects, cure or grounds to stop treatment.
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 standard-treatment comparisons, noninferiority and long-term clinical outcomes have no linked material.
Required materials and conditions
Direct standard-treatment comparisons and clinical outcomes
Materials to obtain first
Direct standard-treatment comparisons, noninferiority and long-term clinical outcomes have no linked material.
Further research
Material needed: Direct standard-treatment comparisons, noninferiority and long-term clinical outcomes have no linked material. 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 standard-treatment comparisons 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 Direct standard-treatment comparisons and clinical outcomes with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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 funding, the developer-instructor and conflicts distinguished?

Current findings
Original funding records Zurich Lung Association/clinical support and a training developer-instructor among the authors. This is not converted into complete conflict verification or independence certification.
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
Funding roles, equipment/instrument support, developer-instructor roles, employee authors, COI and analysis/reporting involvement are unverified.
Required materials and conditions
Original support, product, employee/developer and COI records
Materials to obtain first
Funding roles, equipment/instrument support, developer-instructor roles, employee authors, COI and analysis/reporting involvement are unverified.
Further research
Material needed: Funding roles, equipment/instrument support, developer-instructor roles, employee authors, COI and analysis/reporting involvement 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 Original support, product, employee/developer and COI records 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 Original support, product, employee/developer and COI records with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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

N25 · What was reported about safety and sample-size limits?

Current findings
The original parent safety label is Good; no unexpected/adverse events were reported in 25 people over four months. This is not extended to absence of rare harms, long-term safety or safety of stopping established treatment.
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
Collection methods, event definitions, arm denominators, rare/long-term harms and treatment-cessation material are unverified.
Required materials and conditions
Harm collection, exposure, arm denominators and follow-up
Materials to obtain first
Collection methods, event definitions, arm denominators, rare/long-term harms and treatment-cessation material are unverified.
Further research
Material needed: Collection methods, event definitions, arm denominators, rare/long-term harms and treatment-cessation material 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 Harm collection, exposure, arm 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 Harm collection, exposure, arm denominators and follow-up with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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

N26 · Are parent values, subclaim grade and the evidence date separated?

Current findings
Parent C50, B/P/R1/I1/E+/B2/CX, four false flags, empty override and subclaim C/note are preserved. Original bilingual wording, 2026-09-07, empty corrections array and empty deliberation string are not inherited as the current review date or a 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/subclaim original values and historical dates with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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

N27 · 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 statements, summary use and external access with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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

N28 · 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 Linking summary reading, unread originals and needed material with selected daytime sleepiness in moderate OSA, the structured program/wait list, the same paper/registration, respondents, ESS versus other endpoints, times, denominators 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