RATIONALE Around 20-35% of obstructive sleep apnoea (OSA) patients show supine-isolated OSA, where supine sleep avoidance could be an effective therapy. However, traditional supine discomfort-based methods show poor tolerance and compliance to treatment, so cannot be recommended. Supine-alarm devices show promise, but evidence to support favourable adherence to treatment and effectiveness at reducing excessive daytime sleepiness compared to continuous positive airway pressure (CPAP) remains limited. OBJECTIVES To establish if alarm-based supine-avoidance treatment in supine-isolated OSA patients is non-inferior to CPAP in reducing daytime sleepiness. METHODS Following baseline questionnaires and in-home supine-time and polysomnography assessments, patients with supine-isolated OSA and Epworth sleepiness scale (ESS) score ≥8 were randomised to ≥6 weeks of supine-avoidance or CPAP treatment, followed by cross-over to the remaining treatment with repeat assessments. Non-inferiority was assessed from change in ESS with supine-avoidance compared to CPAP using a pre-specified non-inferiority margin of 1.5. Average nightly treatment use over all nights, and treatment efficacy and effectiveness at reducing respiratory disturbances were also compared between treatments. RESULTS The reduction in sleepiness score with supine-avoidance (mean [95%CI] -1.9 [-2.8 to -1.0]) was non-inferior to CPAP (-2.4 [-3.3 to -1.4], supine-avoidance-CPAP difference -0.4 [-1.3 to 0.6]) and the lower confidence limit did not cross the non-inferiority margin of 1.5, p=0.021. Average treatment usage was higher with supine-avoidance compared to CPAP (mean ± SD 5.7 ± 2.4 versus 3.9 ± 2.7 h/night, p<0.001). CONCLUSIONS In patients with supine-isolated OSA, vibro-tactile supine alarm device therapy is non-inferior to CPAP for reducing sleepiness and shows superior treatment adherence.

中文翻译：

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避免仰卧与持续气道正压治疗仰卧孤立性睡眠呼吸暂停的疗效比较。

基本原理 大约 20-35% 的阻塞性睡眠呼吸暂停 (OSA) 患者表现出仰卧孤立性 OSA，其中避免仰卧睡眠可能是一种有效的治疗方法。然而，传统的基于仰卧不适的方法对治疗的耐受性和依从性较差，因此不推荐。仰卧位报警装置显示出前景，但与持续气道正压通气 (CPAP) 相比，支持良好坚持治疗以及减少白天过度嗜睡的有效性的证据仍然有限。目的 确定对仰卧隔离 OSA 患者进行基于警报的仰卧回避治疗在减少日间嗜睡方面是否不逊色于 CPAP。方法 在进行基线问卷调查以及家庭仰卧时间和多导睡眠图评估后，仰卧隔离 OSA 和 Epworth 嗜睡量表 (ESS) 评分≥8 的患者被随机接受≥6 周的避免仰卧或 CPAP 治疗，然后进行交叉治疗通过重复评估进行剩余的治疗。使用预先指定的非劣效性界限 1.5，根据避免仰卧的 ESS 与 CPAP 相比的变化来评估非劣效性。还比较了治疗之间的平均每晚治疗使用情况以及治疗效果和减少呼吸障碍的效果。结果 避免仰卧时嗜睡评分的降低（平均 [95%CI] -1.9 [-2.8 至 -1.0]）并不劣于 CPAP（-2.4 [-3.3 至 -1.4]，仰卧避免与 CPAP 差异） -0.4 [-1.3 至 0.6]），置信下限未超过非劣效性界限 1.5，p=0.021。与 CPAP 相比，避免仰卧位的平均治疗使用率更高（平均值 ± SD 5.7 ± 2.4 对比 3.9 ± 2.7 小时/夜，p<0.001）。结论 对于仰卧孤立性 OSA 患者，振动触觉仰卧报警装置治疗在减少嗜睡方面并不逊色于 CPAP，并且显示出优越的治疗依从性。