Prospective crossover trial of positional and CPAP therapy for the treatment of mild-to-moderate positional obstructive sleep apnea.

Abstract

Study objectives: To evaluate efficacy of vibrotactile positional therapy (PT) compared to standard CPAP therapy in mild-to-moderate positional obstructive sleep apnea (pOSA).

Methods: Prospective crossover randomized controlled trial of adult patients with treatment-naïve, symptomatic, mild-to-moderate pOSA - defined as ≥5 total apnea-hypopnea index (AHI) <30 with supine-to-non-supine (s:ns)AHI ratio ≥2. Participants were randomized to in-laboratory treatment initiation polysomnography with either PT or CPAP on sequential nights before an eight-week trial of each therapy. The primary endpoint was symptomatic improvement (Epworth Sleepiness Scale; ΔESS). Secondary endpoints included patient preference, usage, sleep architecture and quality of life (QoL) measures.

Results: 52 participants were enrolled and completed both arms of the study. Participants were symptomatic with median ESS 12 (IQR 10-14). Treatment resulted in a significant (p<0.001) symptomatic improvement with both PT and CPAP (ΔESS 4; IQR 6-11) without a significant difference between treatment arms (p=0.782). PT was effective at restricting supine sleep and demonstrated improved sleep efficiency compared with CPAP, although no better than baseline. Both therapies were effective at reducing AHI, although CPAP demonstrated superior AHI reduction. There were otherwise no clinically significant differences in sleep architecture, usage, or secondary outcomes including overall patient preference.

Conclusions: In this cohort, treatment with PT or CPAP resulted in clinically significant symptomatic improvement (ΔESS) that was not significantly different between treatment arms. No real difference was seen in other secondary outcome measures. This study provides further evidence to support the use of PT as an alternative first-line therapy with CPAP in appropriately selected patients with pOSA.

Clinical trial registration: Registry: Australian New Zealand Clinic Trials Registry; Name: Prospective crossover trial of Positional and Continuous positive airway pressure Therapy for the treatment of mild-to-moderate positional obstructive sleep apnoea; Identifier: ACTRN12619000475145; URL: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377221&isReview=true.