Rationale Approximately 60% of the patients with obstructive sleep apnoea suffer from a positional effect, and approximately 25% of these patients present events only in the supine position. Objective To validate a new positional vibrating device and evaluate its efficacy in reducing the Apnoea–Hypopnoea Index and the total sleep time in the supine position without disturbing sleep. Methods A total of 128 patients were recruited for this multicentre, prospective, parallel, randomised controlled trial and were distributed in three arms (general recommendations, inactive and active device). Full overnight polysomnography was performed at baseline and at 12 weeks. Anthropometric variables and sleep and quality of life questionnaires were collected at 4, 8 and 12 weeks. Results The Apnoea-Hypopnoea Index decreased from 30.6 per hour to 20.4 per hour (p<0.001) in the active device (AD) group. In this group the reduction was 2.3-fold and 3.3-fold than the ones in the general recommendations (GR) and inactive device (ID) groups, respectively (p=0.014). Sleep time in supine position decreased 17.7%±26.3% in GR group (p<0.001), 13.0%±22.4% with ID group (p<0.001) and 21.0%±25.6% in the AD group (p<0.001). Furthermore, total sleep time increased significantly only in the AD group (22.1±57.5 min, p=0.016), with an increased percentage of time in the N3 (deep sleep) and N3+REM (rapid eye movement) stages, without sleep fragmentation. Conclusion The device was effective in reducing the Apnoea–Hypopnoea Index and time spent in the supine position also in improving sleep architecture. Therefore, the device could be a good option for the management of patients with positional obstructive sleep apnoea. Trial registration details The trial was registered at [www.clinicaltrials.gov][1] ([NCT03336515][2]). No data are available. No text will be published. [1]: http://www.clinicaltrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03336515&atom=%2Fthoraxjnl%2F76%2F9%2F930.atom

中文翻译：

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位置性阻塞性睡眠呼吸暂停的新型前额装置：一项随机临床试验

基本原理 大约 60% 的阻塞性睡眠呼吸暂停患者存在体位效应，其中大约 25% 的患者仅在仰卧位出现事件。目的验证一种新的位置振动装置，并评估其在不干扰睡眠的情况下降低呼吸暂停-低通气指数和仰卧位总睡眠时间的功效。方法 本项多中心、前瞻性、平行、随机对照试验共招募了 128 名患者，他们被分配到三组（一般推荐、无源和有源装置）。在基线和 12 周时进行了完整的夜间多导睡眠监测。在第 4、8 和 12 周收集人体测量变量以及睡眠和生活质量问卷。结果 呼吸暂停低通气指数从每小时 30.6 降至 20。有源设备 (AD) 组中每小时 4 次 (p<0.001)。在该组中，减少量分别是一般建议 (GR) 和非活动设备 (ID) 组的 2.3 倍和 3.3 倍 (p=0.014)。GR 组仰卧位睡眠时间减少 17.7%±26.3% (p<0.001)，ID 组减少 13.0%±22.4% (p<0.001)，AD 组减少 21.0%±25.6% (p<0.001)。此外，只有 AD 组的总睡眠时间显着增加（22.1±57.5 分钟，p=0.016），N3（深度睡眠）和 N3+REM（快速眼动）阶段的时间百分比增加，没有睡眠碎片. 结论 该装置可有效降低呼吸暂停-低通气指数和在仰卧位上花费的时间，也可有效改善睡眠结构。所以，该设备可能是治疗位置性阻塞性睡眠呼吸暂停患者的不错选择。试验注册详情 试验注册于 [www.clinicaltrials.gov][1] ([NCT03336515][2])。没有可用数据。不会发布任何文本。[1]：http://www.clinicaltrials.gov [2]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03336515&atom=%2Fthoraxjnl%2F76%2F9%2F930.atom