Study Objectives: We evaluated the efficacy of vibrotactile positional therapy (PT) compared to standard continuous positive airway pressure (CPAP) therapy in mild-to-moderate positional obstructive sleep apnea. Methods: We conducted a prospective crossover randomized controlled trial of adult patients with treatment-naïve, symptomatic, mild-to-moderate positional obstructive sleep apnea, defined as ≥ 5 total apnea-hypopnea index < 30 with supine-to-nonsupine apnea-hypopnea index ratio ≥ 2. Participants were randomized to in-laboratory treatment initiation polysomnography with either PT or CPAP on sequential nights before an 8-week trial of each therapy. The primary end point was symptomatic improvement (Epworth Sleepiness Scale; ΔESS). Secondary end points included patient preference, usage, sleep architecture, and quality of life measures. Results: A total of 52 participants were enrolled and completed both arms of the study. Participants were symptomatic with a median ESS score of 12 (interquartile range, 10–14). Treatment resulted in a significant (P < .001) symptomatic improvement with both PT and CPAP (ΔESS 4; interquartile range, 6–11) without a significant difference between treatment arms (P = .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 apnea-hypopnea index, although CPAP demonstrated superior apnea-hypopnea index 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 positional obstructive sleep apnea. Clinical Trial Registration: Registry: Australian New Zealand Clinical Trials Registry; Name: Prospective crossover trial of Positional and Continuous positive airway pressure Therapy for the treatment of mild-to-moderate positional obstructive sleep apnea; URL: <a href="https://anzctr.org.au/Trial/Registration/TrialReview.aspx%3Fid=377221&isReview=true">https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377221&isReview=true</a>; Identifier: ACTRN12619000475145. Citation: Wilson MR, Carroll R, Kinder S, et al. Prospective crossover trial of positional and CPAP therapy for the treatment of mild-to-moderate positional obstructive sleep apnea. J Clin Sleep Med. 2025;21(2):305–313.

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

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发表日期：

2025年2月1日

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Malcolm R. Wilson,
Robert Carroll,
Stephen Kinder,
Alexander Ryan,
Craig A. Hukins,
Brett Duce,
Claire M. Ellender

摘要

Study Objectives:

We evaluated the efficacy of vibrotactile positional therapy (PT) compared to standard continuous positive airway pressure (CPAP) therapy in mild-to-moderate positional obstructive sleep apnea.

Methods:

We conducted a prospective crossover randomized controlled trial of adult patients with treatment-naïve, symptomatic, mild-to-moderate positional obstructive sleep apnea, defined as ≥ 5 total apnea-hypopnea index < 30 with supine-to-nonsupine apnea-hypopnea index ratio ≥ 2. Participants were randomized to in-laboratory treatment initiation polysomnography with either PT or CPAP on sequential nights before an 8-week trial of each therapy. The primary end point was symptomatic improvement (Epworth Sleepiness Scale; ΔESS). Secondary end points included patient preference, usage, sleep architecture, and quality of life measures.

Results:

A total of 52 participants were enrolled and completed both arms of the study. Participants were symptomatic with a median ESS score of 12 (interquartile range, 10–14). Treatment resulted in a significant (P < .001) symptomatic improvement with both PT and CPAP (ΔESS 4; interquartile range, 6–11) without a significant difference between treatment arms (P = .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 apnea-hypopnea index, although CPAP demonstrated superior apnea-hypopnea index 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 positional obstructive sleep apnea.

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

Citation:

Wilson MR, Carroll R, Kinder S, et al. Prospective crossover trial of positional and CPAP therapy for the treatment of mild-to-moderate positional obstructive sleep apnea. J Clin Sleep Med. 2025;21(2):305–313.