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Abstract
Introduction To date, continuous positive airway pressure (CPAP) remains the cornerstone of obstructive sleep apnoea treatment. CPAP data describing residual sleep-disordered breathing events (ie, the CPAP-measured apnoea–hypopnoea indices (AHI-CPAPflow)) is difficult to interpret because it is an entirely different metric than the polysomnography (PSG) measured AHI gold standard (AHI-PSGgold). Moreover, manufacturer definitions for apnoea and hypopnoea are not only different from those recommended for PSG scoring, but also different between manufacturers. In the context of CPAP initiation and widespread telemedicine at home to facilitate sleep apnoea care, there is a need for concrete evidence that AHI-CPAPflow can be used as a surrogate for AHI-PSGgold.
Methods and analysis No published systematic review and meta-analysis (SRMA) has compared the accuracy of AHI-CPAPflow against AHI-PSGgold and the primary objective of this study is therefore to do so using published data. The secondary objectives are to similarly evaluate other sleep disordered breathing indices and to perform subgroup analyses focusing on the inclusion/exclusion of central apnoea patients, body mass index levels, CPAP device brands, pressure titration modes, use of a predetermined and fixed pressure level or not, and the impact of a 4% PSG desaturation criteria versus 3% PSG on accuracy. The Preferred Reporting Items for SRMA protocols statement guided study design. Randomised controlled trials and observational studies of adult patients (≥18 years old) treated by a CPAP device will be included. The CPAP intervention and PSG comparator must be performed synchronously. PSGs must be scored manually and follow the American Academy of Sleep Medicine guidelines (2007 AASM criteria or more recent). To assess the risk of bias in each study, the Quality Assessment of Diagnostic Accuracy Studies 2 tool will be used.
Ethics and dissemination This protocol received ethics committee approval on 16 July 2020 (IRB_MTP_2020_07_2020000404) and results will be disseminated via peer-reviewed publications.
PROSPERO/Trial registration numbers CRD42020159914/NCT04526366; Pre-results
- sleep medicine
- respiratory physiology
- heart failure
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Footnotes
Twitter @SuehsCarey
Contributors All authors contributed to conceptualising and designing the study. FB, CMS and DJ drafted the manuscript. JPM, MCR, JLP, FG, EML, AB and NM commented on important intellectual content and made revisions. All authors read and approved the final version of the manuscript. CMS and DJ accept full responsibility for the finished manuscript and controlled the decision to publish.
Funding Though sponsored by the University Hospitals of Montpellier, Montpellier, France, the sponsor had no role in the study design or crafting of this paper.
Competing interests AB reports grants, personal fees, non-financial support and other from AstraZeneca, grants, personal fees and other from GSK, grants, personal fees, non-financial support and other from Boeringher Ingelheim, personal fees, non-financial support and other from Novartis, personal fees and other from Teva, personal fees and other from Regeneron, personal fees, non-financial support and other from Chiesi Pharmaceuticals, personal fees, non-financial support and other from Actelion, other from Gilead, and personal fees and non-financial support from Roche, outside the submitted work. FG reports grants and personal fees from ResMed, personal fees and non-financial support from Sefam, personal fees from Cidelec, personal fees and non-financial support from Novartis, personal fees and non-financial support from Nyxoah, non-financial support from Boehringer Ingelheim, grants and personal fees from Philips Respironics, and non-financial support from Asten, outside the submitted work. DJ reports personal fees from Philips Healthcare, from ResMed, personal fees and non-financial support from Sefam, personal fees from Lowenstein, personal fees from GSK, from Boehringher Ingelheim, grants and personal fees from Novartis, personal fees and non-financial support from AstraZeneca, personal fees from Chiesi Pharmaceuticals and personal fees from Sanofi, outside the submitted work. JLP reports grants and other from Air Liquide Foundation, grants, personal fees and other from AGIR a dom, grants, personal fees and other from AstraZeneca, grants and other from Fisher & Paykel, grants and other from Mutualia, grants, personal fees and other from Philips, grants, personal fees and other from ResMed, grants and other from VitalAire, personal fees from AstraZeneca, personal fees from Boehringer Ingelheim, personal fees from Jazz Pharmaceuticals, personal fees from NightBalance and personal fees from Sefam, outside the submitted work. NM and CMS report grants from AstraZeneca, outside the submitted work.
Provenance and peer review Not commissioned; externally peer-reviewed.
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