Evidence map›Paper›PMID 41199276›Full record

ArticleTrials2025

Statistical analysis plan for continuous positive airway pressure plus mandibular advancement therapy (PAPMAT): an adaptive randomised crossover trial comparing the benefits and costs of combining two established treatments for obstructive sleep apnoea.

Martin Law, Yi-Da Chiu, Sofía S Villar, Timothy Quinnell

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Martin LawRoyal Papworth Hospital NHS Foundation Trust, Cambridge, CB2 0AY, UK. martin.law@mrc-bsu.cam.ac.uk.ORCID http://orcid.org/0000-0001-9594-348X
Yi-Da ChiuRoyal Papworth Hospital NHS Foundation Trust, Cambridge, CB2 0AY, UK.
Sofía S VillarRoyal Papworth Hospital NHS Foundation Trust, Cambridge, CB2 0AY, UK.
Timothy QuinnellRoyal Papworth Hospital NHS Foundation Trust, Cambridge, CB2 0AY, UK.

Funding

Research for Patient Benefit Programme NIHR201124
6 · The paper itself

Abstract

backgroundObstructive sleep apnoea is caused by closure of the upper airway during sleep due to excessive muscle relaxation. It is treated with continuous positive airway pressure (CPAP), a machine connected to a mask worn by a patient during sleep, which generates pressure to keep the throat open. CPAP is highly effective, but often not tolerated, sometimes due to the required pressure of the machine. Mandibular advancement devices advance the lower jaw, increasing airway space. Using such a device may open the airway enough to allow CPAP pressure to be reduced, resulting in more patients being able to tolerate using the CPAP machine. METHODS/

designThe PAPMAT trial is a multicentre, randomised controlled crossover trial. It will measure CPAP machine adherence for participants with obstructive sleep apnoea, comparing their adherence when using a CPAP machine alone to using a CPAP machine in conjunction with a mandibular advancement device. The sample size will be re-estimated after at least 50% of participants have completed follow-up. This document is the statistical analysis plan, which gives details of the planned analysis, including the sample size re-estimation.

trial registrationISRCTN 33966032. Registered 18th February 2022.

Indexed as

Continuous Positive Airway PressureHealth Care CostsMandibular AdvancementSleep Apnea, ObstructiveCombined Modality TherapyCost-Benefit AnalysisCross-Over StudiesData Interpretation, StatisticalHumansMulticenter Studies as TopicPatient ComplianceRandomized Controlled Trials as TopicTreatment OutcomeAdaptive designCPAPCrossoverMandibular advancement deviceSample size re-estimationSleep apnoeaStatistical analysis plan

Identifiers

PMID41199276
PMCPMC12590605

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.