Abstract
IntroductionContinuous positive airway pressure (CPAP) is currently the treatment of choice for sleepiness in patients with obstructive sleep apnoea (OSA); however, adherence is often thought to be suboptimal. We investigated the effects of suboptimal CPAP usage on objective and subjective sleepiness parameters in patients with OSA.
Material and methodsIn this 2-week, parallel, double-blind, randomised controlled trial we enrolled moderate-to-severe OSA patients with excessive pre-treatment daytime sleepiness (Epworth sleepiness scale (ESS) score >10 points) who had suboptimal CPAP adherence over ≥12 months (mean nightly usage time 3–4 h). Patients were allocated through minimisation to either subtherapeutic CPAP (“sham CPAP”) or continuation of CPAP (“therapeutic CPAP”). A Bayesian analysis with historical priors calculated the posterior probability of superiority.
ResultsBetween May, 2016 and November, 2018, 57 patients (aged 60±8 years, 79% male, 93% Caucasian) were allocated in total, and 52 who completed the study (50% in each arm) were included in the final analysis. The unadjusted ESS score increase was 2.4 points (95% CI 0.6–4.2, p=0.01) in the sham-CPAP group when compared to continuing therapeutic CPAP. The probability of superiority of therapeutic CPAP over sham CPAP was 90.4% for ESS, 90.1% for systolic blood pressure and 80.3% for diastolic blood pressure.
ConclusionsPatients with moderate-to-severe OSA and daytime sleepiness are still getting a substantial benefit from suboptimal CPAP adherence, albeit not as much as they might get if they adhered more. Whether a similar statement can be made for even lower adherence levels remains to be established in future trials.
Abstract
阻塞性睡眠呼吸暂停患者,白天sleepiness are still getting a substantial benefit from suboptimal CPAP adherence (i.e.3–4 h per night), albeit not as much as they might get if they adhered morehttp://bit.ly/2Phgeo2
Footnotes
This article has an editorial commentary:https://doi.org/10.1183/13993003.00144-2020
This article has supplementary material available fromwww.qdcxjkg.com
This trial is registered atClinicalTrials.gov(NCT02781740).
The anonymised raw data from this trial are available upon request from the senior author.
Author contributions: T. Gaisl, M. Roos and S.R. Haile had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: T. Gaisl, K.E. Bloch, J.R. Stradling and M. Kohler. Acquisition, analysis or interpretation of data: all authors. Drafting of the manuscript: T. Gaisl. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: T. Gaisl, M. Roos and S.R. Haile. Administrative, technical or material support: T. Gaisl and M. Kohler. Study supervision: M. Kohler.
支持声明:这是一个investigator-initiated trial and supported by the Swiss National Science Foundation (project number 32003B_162534). The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Funding information for this article has been deposited with theCrossref Funder Registry.
Conflict of interest: P. Rejmer has nothing to disclose.
Conflict of interest: S. Thiel has nothing to disclose.
Conflict of interest: S.R. Haile has nothing to disclose.
Conflict of interest: M. Osswald has nothing to disclose.
Conflict of interest: M. Roos has nothing to disclose.
Conflict of interest: K.E. Bloch has nothing to disclose.
Conflict of interest: J.R. Stradling reports personal fees for consultancy from Bayer AG and ResMed, outside the submitted work.
Conflict of interest: M. Kohler reports personal fees from Bayer AG, grants from University of Zurich and Lunge Zurich, outside the submitted work.
Conflict of interest: T. Gaisl reports personal fees for consultancy from Bayer AG, outside the submitted work.
- ReceivedAugust 1, 2019.
- AcceptedDecember 4, 2019.
- Copyright ©ERS 2020
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