Comparing treatment effects of a convenient vibratory positional device to CPAP in positional OSA: a crossover randomised controlled trial

Abstract

Objectives: Up to 77% of patients with obstructive sleep apnoea (OSA) have positional OSA (POSA) but traditional positional therapy (PT) methods have failed as they were poorly tolerated. New convenient vibratory PT devices have been invented but while recent studies suggest high treatment efficacy and adherence, there are no published data comparing these devices directly with continuous positive airway pressure (CPAP). Our objective is to evaluate if a convenient vibratory PT device is non-inferior to CPAP in POSA treatment.

Methods: In this crossover randomised controlled trial, we enrolled patients with POSA with significant daytime sleepiness (Epworth Sleepiness Scale (ESS)≥10). POSA diagnosis was based on: (1) total Apnoea/Hypopnoea Index (AHI)>10/hour and non-supine AHI<10/hour (2) supine AHI≥2 × non-supine AHI. Patients used their initial allocated devices (PT or CPAP) for 8 weeks before crossing to the alternative intervention after a 1 week washout. The primary aim is to measure changes in ESS between the two treatments. Secondary outcomes include sleep study parameters and patient treatment preference (ClinicalTrials.gov: NCT03125512).

Results: 40 patients completed the trial between April 2017 and December 2018. Difference in ESS after 8 weeks of device use (PT minus CPAP) was 2.0 (95% CI 0.68 to 3.32), exceeding our predetermined non-inferiority margin of 1.5. AHI on CPAP was lower than with PT (4.0±3.2 vs 13.0±13.8 events/hour, respectively, p=0.001), although both were lower than at baseline. Time spent supine was significantly lower with PT than CPAP (p<0.001). 60% of patients preferred CPAP, 20% preferred PT, while 20% preferred neither device.

Conclusions: The non-inferiority ESS endpoint for PT compared with CPAP was not met and the results were inconclusive. Future trials with larger sample sizes or in less symptomatic patients are warranted to provide further insight into the role of these new vibratory PT devices.

Keywords: sleep apnoea.

Figure 1

Trial flow diagram. CPAP, continuous positive airway pressure; ESS, Epworth Sleepiness Scale; OSA, obstructive sleep apnoea; PT, positional therapy.

Figure 2

Graph demonstrating that the non-inferiority endpoint of ESS for PT was not met. The criteria for non-inferiority would be met if the mean difference in ESS and its 95% CIs lay to the left of the non-inferiority margin of +1.5. CPAP, continuous positive airway pressure; ESS, Epworth Sleepiness Scale; PT, positional therapy.

Figure 3

Patient treatment adherence. CPAP, continuous positive airway pressure; PT, positional therapy.

Figure 4

Patient treatment preference. (A) Patients were asked which treatment device they prefer at the end of the trial. (B) Patients were asked which treatment device they prefer if both devices cost the same. CPAP, continuous positive airway pressure.