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

Abstract

ObjectivesUp 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.MethodsIn 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).Results40 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.ConclusionsThe 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.

European Respiratory Society guideline on non-CPAP therapies for obstructive sleep apnoea

“…Similarly, MMO can be an alternative for patients experiencing CPAP failure [106]. Finally, despite very low certainty of evidence, patients with mild to moderate position-dependent OSA can be treated with vibratory positional therapy as compared to CPAP or as compared to mandibular advancement [83,84,88,89].…”

“…For PICOs 7 and 8, 1632 studies were originally identified, five of them for PICO 7, including 221 participants who were randomised to either positional therapy or CPAP (supplementary figures e7 and e12, supplementary tables e10 and e18) [78][79][80][81][82][83][84]. For the definition of positional OSA, all studies shared the criterion of the supine AHI to be at least twice as high as the nonsupine AHI.…”

“…Another study (n=20) applied the "tennis ball technique" (TBT) [81]. MOK et al [83] (n=40) used the Night Shift device (vibratory device worn around the neck); BERRY et al…”

“…It was measured using the ESS and showed no clinically relevant difference (CPAP 8.89, positional therapy +1.22; 95% CI 0.26-2.17). Health-related quality of life was assessed in the same three studies and 170 participants [81,83,84] using the SF-36 and showed a mean value of 69.66 and was very similar on positional therapy, i.e. 0.6 points lower (−4.34-3.15 points).…”

Validation Study of Airgo, an Innovative Device to Screen Sleep Respiratory Disorders

“…A prevalence of 13% of pOSA is close to figures of the literature. Considering that pOSA can be treated effectively with specific instruments (15), such as postural trainers or mandibular advancement devices, when waiting lists for standard diagnosis cause a significant delay in the management, the treatment could be instituted immediately. The percentage of time spent in the different positions is reported under each RIC, and if less than 10% of time is spent in the supine position, the reliability is low and requires further validation.…”