Department of Oral and Maxillofacial Surgery, Academic Medical Center, Amsterdam, The Netherlands.
Department of Otorhinolaryngology Head and Neck Surgery, OLVG West, Jan Tooropstraat 164 1061 AE, Amsterdam, The Netherlands.
Sleep Breath. 2018 May;22(2):441-450. doi: 10.1007/s11325-017-1568-4. Epub 2017 Sep 15.
The Sleep Position Trainer (SPT) is a new option for treating patients with positional obstructive sleep apnea (POSA). This study investigated long-term efficacy, adherence, and quality of life during use of the SPT device compared with oral appliance therapy (OAT) in patients with POSA.
This prospective, multicenter trial randomized patients with mild to moderate POSA (apnea-hypopnea index [AHI] 5-30/h) to SPT or OAT. Polysomnography was performed at baseline and after 3 and 12 months' follow-up. The primary endpoint was OSA severity; adherence, quality of life, and adverse events were also assessed.
Ninety-nine patients were randomized and 58 completed the study (29 in each group). Median AHI in the SPT group decreased from 13.2/h at baseline to 7.1/h after 12 months (P < 0.001); corresponding values in the OAT group were 13.4/h and 5.0/h (P < 0.001), with no significant between-group difference (P = 1.000). Improvements throughout the study were maintained at 12 months. Long-term median adherence was also similar in the two treatment groups; the proportion of patients who used their device for ≥ 4 h for 5 days in a week was 100% in the SPT group and 97.0% in the OAT group (P = 0.598).
The efficacy of SPT therapy was maintained over 12 months and was comparable to that of OAT in patients with mild to moderate POSA. Adherence was relatively high, and similar in the two groups.
www.clinicaltrials.gov (NCT02045576).
睡眠体位训练器（SPT）是治疗体位性阻塞性睡眠呼吸暂停（POSA）患者的一种新选择。本研究比较了 SPT 装置与口腔矫正器治疗（OAT）在治疗 POSA 患者时的长期疗效、依从性和使用期间的生活质量。
这是一项前瞻性、多中心试验，将轻度至中度 POSA（呼吸暂停低通气指数 [AHI] 5-30/h）患者随机分为 SPT 或 OAT 组。基线时和 3 个月及 12 个月随访时进行多导睡眠图检查。主要终点是 OSA 严重程度；同时评估依从性、生活质量和不良事件。
99 例患者被随机分组，58 例完成研究（每组 29 例）。SPT 组的中位 AHI 从基线时的 13.2/h 下降到 12 个月时的 7.1/h（P<0.001）；OAT 组相应的数值分别为 13.4/h 和 5.0/h（P<0.001），两组间无显著差异（P=1.000）。整个研究过程中的改善在 12 个月时得以维持。两种治疗组的长期中位依从性也相似；SPT 组中每周使用设备 5 天、每天使用≥4 小时的患者比例为 100%，OAT 组为 97.0%（P=0.598）。
SPT 治疗的疗效在 12 个月内得以维持，在轻度至中度 POSA 患者中与 OAT 相当。依从性相对较高，两组间无差异。
