Wilson Malcolm R, Carroll Robert, Kinder Stephen, Ryan Alexander, Hukins Craig A, Duce Brett, Ellender Claire M
Department of Respiratory & Sleep Medicine, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.
Department of Respiratory & Sleep Medicine, Logan Hospital, Meadowbrook, Queensland, Australia.
J Clin Sleep Med. 2025 Feb 1;21(2):305-313. doi: 10.5664/jcsm.11378.
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.
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.
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 ( < .001) symptomatic improvement with both PT and CPAP (ΔESS 4; interquartile range, 6-11) without a significant difference between treatment arms ( .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.
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.
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.
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. 2025;21(2):305-313.
我们评估了振动触觉定位疗法（PT）与标准持续气道正压通气（CPAP）疗法相比，在治疗轻至中度体位性阻塞性睡眠呼吸暂停中的疗效。
我们对初治、有症状、轻至中度体位性阻塞性睡眠呼吸暂停的成年患者进行了一项前瞻性交叉随机对照试验，定义为仰卧位与非仰卧位呼吸暂停低通气指数比值≥2，总呼吸暂停低通气指数≥5且<30。参与者被随机分配在每种疗法为期8周的试验前，连续两晚在实验室进行治疗起始多导睡眠图检查，分别接受PT或CPAP治疗。主要终点是症状改善情况（爱泼沃斯嗜睡量表；ESS变化值）。次要终点包括患者偏好、使用情况、睡眠结构和生活质量指标。
共有52名参与者入组并完成了研究的两个阶段。参与者有症状，ESS评分中位数为12（四分位间距，10 - 14）。PT和CPAP治疗均使症状有显著改善（P <.001）（ESS变化值为4；四分位间距，6 - 11），治疗组之间无显著差异（P =.782）。PT在限制仰卧位睡眠方面有效，与CPAP相比睡眠效率有所提高，尽管不比基线更好。两种疗法在降低呼吸暂停低通气指数方面均有效，尽管CPAP在降低呼吸暂停低通气指数方面表现更优。在睡眠结构、使用情况或包括总体患者偏好在内的次要结局方面，没有其他临床显著差异。
在该队列中，PT或CPAP治疗均带来了临床显著的症状改善（ESS变化值），治疗组之间无显著差异。在其他次要结局指标方面未发现实际差异。本研究提供了进一步证据，支持在适当选择的体位性阻塞性睡眠呼吸暂停患者中，将PT作为CPAP的替代一线疗法。
注册机构：澳大利亚新西兰临床试验注册中心；名称：体位性和持续气道正压通气疗法治疗轻至中度体位性阻塞性睡眠呼吸暂停的前瞻性交叉试验；网址：https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377221&isReview=true；标识符：ACTRN12619000475145。
Wilson MR, Carroll R, Kinder S,等。体位性和CPAP疗法治疗轻至中度体位性阻塞性睡眠呼吸暂停的前瞻性交叉试验。2025；21(2):305 - 313。
