A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea.
A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea.
复制标题
口压疗法治疗阻塞性睡眠呼吸暂停的多中心评估。
DOI：
10.1016/j.sleep.2013.05.009
复制
发表时间：
2013
期刊：
影响因子：
4.8
通讯作者：
Malhotra,Atul
中科院分区：
文献类型：
--
作者：
Colrain,IanM;Black,Jed;Siegel,LawrenceC;Bogan,RichardK;Becker,PhilipM;Farid-Moayer,Mehran;Goldberg,Rochelle;Lankford,DAlan;Goldberg,AndrewN;Malhotra,Atul
目的评价一种新的无创口腔压力疗法(OPT)(Winx®，ApniCure)系统对阻塞性睡眠呼吸暂停(OSA)患者睡眠呼吸紊乱、睡眠结构和睡眠稳定性的多导睡眠监测的影响。受试者和方法在5家美国睡眠医学学会(AASM)认证的睡眠诊所和1家研究实验室进行了为期4周、多中心、前瞻性、开放标签、随机、交叉、首夜顺序对照和治疗的单臂试验。从367名受试者中筛选出63名受试者(分析队列)进行研究。分析队列为69.8%的男性，年龄53.6±88.9岁，平均体重指数为32.3±44.5 kg/m2，合并轻度至重度阻塞性睡眠呼吸暂停。在治疗开始时，受试者被随机分配到接受治疗的一晚和没有接受(对照)治疗的一晚，并在28晚的治疗后再次进行评估。根据AASM标准，每晚由一名集中计分员根据盲法评分评估呼吸和睡眠结构。结果平均每晚使用时间为6.0±111.4h，未发生严重或严重的设备相关不良事件。中位呼吸暂停低通气指数(AHI)：对照组为27.5次/小时，首次治疗夜为13.4次/小时，治疗28天后为14.8次/小时。在接受评估的63名受试者中，有20名患者出现了临床显着反应(治疗前呼吸暂停，⩽为对照组的10%，⩽为对照组的50%)。与对照组相比，两个治疗夜的快速眼动百分比(REM%)显著增加，N1%、到N1睡眠的阶段转换、总体阶段转换、总觉醒和每小时唤醒均显著减少。在参与OPT研究前，未接受治疗两周或以上的患者的平均Epworth嗜睡评分(ESS)从12.1降至8.6(Cohendeffect Size，0.68)，而直接从持续气道正压(CPAP)治疗转为OPT的受试者则保持不变。结论在一个容易识别的亚组中，睡眠质量和连续性、AHI、ODI、ESS和总体临床状态均有显著改善。OPT是安全的，耐受性良好，夜间使用量很高。
ObjectiveWe aimed to evaluate the impact of a novel noninvasive oral pressure therapy (OPT) (Winx®, ApniCure) system on polysomnographic measures of sleep-disordered breathing, sleep architecture, and sleep stability in obstructive sleep apnea (OSA).Subjects and methodsA 4-week, multicenter, prospective, open-label, randomized, crossover, first-night order of control vs treatment, single-arm trial was conducted in five American Academy of Sleep Medicine (AASM) – accredited sleep clinics and one research laboratory. Sixty-three subjects (analysis cohort) were studied from a screening cohort of 367 subjects. The analysis cohort was 69.8% men, ages 53.6 ± 8.9 years (mean ± SD), body mass index of 32.3 ± 4.5 kg/m2, with mild to severe OSA. At treatment initiation, subjects received random assignment to one night with and one without (control) treatment, and they were assessed again following 28 nights of treatment. Breathing and sleep architecture were assessed each night based on blind scoring by a single centralized scorer using AASM criteria.ResultsAverage nightly usage across the take-home period was 6.0 ± 1.4 h. There were no severe or serious device-related adverse events (AEs). Median apnea–hypopnea index (AHI) was 27.5 events per hour on the control night, 13.4 events per hour on the first treatment night, and 14.8 events per hour after 28 days of treatment. A clinically significant response (treatment AHI ⩽10/h and ⩽50% of control values) was seen in 20 of the 63 subjects evaluated. Rapid eye movement percentage (REM%) was significantly increased, and N1%, stage shifts to N1 sleep, overall stage shifts, total awakenings, and arousals per hour were all significantly reduced at both treatment nights compared to controls. Mean Epworth sleepiness scale (ESS) was significantly reduced from 12.1 to 8.6 (Cohendeffect size, 0.68) in those untreated for two or more weeks prior to OPT study participation and remained unchanged in subjects who directly switched from continuous positive airway pressure (CPAP) therapy to OPT.ConclusionClinically significant improvements in sleep quality and continuity, AHI, ODI, ESS, and overall clinical status were achieved in an easily identified subgroup. OPT was safe and well-tolerated and nightly usage was high.