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.

中文翻译：

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比较方便的振动体位装置与 CPAP 在体位性 OSA 中的治疗效果：一项交叉随机对照试验

目标 多达 77% 的阻塞性睡眠呼吸暂停 (OSA) 患者患有体位性 OSA (POSA)，但传统的体位疗法 (PT) 方法因耐受性差而失败。已经发明了新的方便的振动 PT 设备，但虽然最近的研究表明治疗效果和依从性高，但没有公开的数据将这些设备与持续气道正压通气 (CPAP) 直接进行比较。我们的目标是评估方便的振动 PT 设备在 POSA 治疗中是否不劣于 CPAP。方法 在这项交叉随机对照试验中，我们招募了白天有明显嗜睡（Epworth 嗜睡量表（ESS）≥10）的 POSA 患者。POSA 诊断基于： (1) 总呼吸暂停/低通气指数 (AHI)>10/小时且非仰卧位 AHI<10/小时 (2) 仰卧位 AHI≥2 × 非仰卧位 AHI。患者使用他们最初分配的设备（PT 或 CPAP）8 周，然后在 1 周清除后过渡到替代干预。主要目的是测量两种处理之间 ESS 的变化。次要结果包括睡眠研究参数和患者治疗偏好（ClinicalTrials.gov：NCT03125512）。结果 40 名患者在 2017 年 4 月至 2018 年 12 月期间完成了试验。 使用设备 8 周后 ESS 的差异（PT 减去 CPAP）为 2.0（95% CI 0.68 至 3.32），超过了我们预定的非劣效性界限 1.5。CPAP 的 AHI 低于 PT（分别为 4.0±3.2 和 13.0±13.8 个事件/小时，p=0.001），尽管两者都低于基线。PT 的仰卧时间显着低于 CPAP（p<0.001）。60% 的患者首选 CPAP，20% 的患者首选 PT，而 20% 的人不喜欢这两种设备。结论 与 CPAP 相比，PT 的非劣效性 ESS 终点未达到，结果尚无定论。未来有必要进行更大样本量或症状较轻患者的试验，以进一步了解这些新型振动 PT 设备的作用。