Abstract
Introduction Continuous positive airway pressure (CPAP) is currently the treatment of choice for sleepiness in patients with obstructive sleep apnea (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 Methods In 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 at least 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.
Results Between May, 2016 and November, 2018, 57 patients (60±8 years, 79% men, 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 to +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, and 80.3% for diastolic blood pressure.
Conclusions Patients 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.
Footnotes
This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.
Conflict of interest: Dr. Gaisl reports personal fees from Bayer AG (consulting), outside the submitted work.
Conflict of interest: Dr. Rejmer has nothing to disclose.
Conflict of interest: Dr. Thiel has nothing to disclose.
Conflict of interest: Dr. Haile has nothing to disclose.
Conflict of interest: Dr. Osswald has nothing to disclose.
Conflict of interest: Dr. Roos has nothing to disclose.
Conflict of interest: Dr. Bloch has nothing to disclose.
Conflict of interest: Dr. Stradling reports personal fees from Bayer AG, personal fees from ResMed, outside the submitted work.
Conflict of interest: Dr. Kohler reports personal fees from Bayer AG, grants from University of Zurich, grants from Lunge Zurich, outside the submitted work.
- Received August 1, 2019.
- Accepted December 3, 2019.
- Copyright ©ERS 2019