Benoist Linda, de Ruiter Maurits, de Lange Jan, de Vries Nico
Department of Otorhinolaryngology Head and Neck Surgery, OLVG West, Amsterdam, The Netherlands; Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands.
Department of Oral and Maxillofacial Surgery, Academic Medical Center, Amsterdam, The Netherlands; Department of Oral Kinesiology, Amsterdam, The Netherlands.
Sleep Med. 2017 Jun;34:109-117. doi: 10.1016/j.sleep.2017.01.024. Epub 2017 Mar 27.
To compare the effectiveness of positional therapy (PT) with the sleep position trainer (SPT) to oral appliance therapy (OAT) in patients with mild-to-moderate positional obstructive sleep apnea (POSA).
Multicenter, prospective, randomized, controlled trial. Patients with mild-to-moderate POSA (apnea-hypopnea index (AHI) ≥5 ≤ 30/hour sleep) were randomized for PT or OAT. Polysomnography was repeated after 3 months. Efficacy, adherence, mean disease alleviation (MDA), quality of life, dropouts and adverse events were evaluated.
A total of 177 patients were screened for the study; 99 underwent randomization and 81 completed the study. Intention-to-treat (ITT) analysis of median [IQR] AHI showed a reduction in the PT group from 13.0 [9.7-18.5] to 7.0 [3.8-12.8], p < 0.001 and in the OAT group from 11.7 [9.0-16.2] to 9.1 [4.9-11.7], p < 0.001. Mean adherence (≥4 h/night, ≥5 days/week) was 89.3 ± 22.4% for SPT versus 81.3 ± 30.0% in OAT patients, p = 0.208.
Oral appliance therapy and positional therapy were equally effective in reducing the median AHI in patients with mild-to-moderate POSA. The results of this study have important implications for future OSA treatment guidelines and daily clinical practice. CLINICALTRIALS.
NCT02045576.
比较体位疗法（PT）联合睡眠体位训练器（SPT）与口腔矫治器疗法（OAT）治疗轻至中度体位性阻塞性睡眠呼吸暂停（POSA）患者的疗效。
多中心、前瞻性、随机对照试验。轻至中度POSA（呼吸暂停低通气指数（AHI）≥5且≤30次/小时睡眠）患者被随机分为PT组或OAT组。3个月后重复进行多导睡眠图检查。评估疗效、依从性、平均疾病缓解率（MDA）、生活质量、退出研究情况和不良事件。
共177例患者被纳入本研究筛查；99例患者进行了随机分组，81例完成了研究。意向性分析（ITT）中，PT组的AHI中位数[四分位间距]从13.0[9.7 - 18.5]降至7.0[3.8 - 12.8]，p < 0.001；OAT组从11.7[9.0 - 16.2]降至9.1[4.9 - 11.7]，p < 0.001。SPT组的平均依从性（≥4小时/晚，≥5天/周）为89.3±22.4%，OAT组患者为81.3±30.0%，p = 0.208。
口腔矫治器疗法和体位疗法在降低轻至中度POSA患者的AHI中位数方面同样有效。本研究结果对未来阻塞性睡眠呼吸暂停（OSA）治疗指南及日常临床实践具有重要意义。临床试验注册号：NCT02045576。
