Bakker Jessie P, Wang Rui, Weng Jia, Aloia Mark S, Toth Claudia, Morrical Michael G, Gleason Kevin J, Rueschman Michael, Dorsey Cynthia, Patel Sanjay R, Ware James H, Mittleman Murray A, Redline Susan
Division of Sleep & Circadian Disorders, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Division of Sleep & Circadian Disorders, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA.
Chest. 2016 Aug;150(2):337-45. doi: 10.1016/j.chest.2016.03.019. Epub 2016 Mar 24.
Motivational enhancement (ME) shows promise as a means of increasing adherence to CPAP for OSA.
We performed an open-label, parallel-arm, randomized controlled trial of CPAP only or CPAP + ME, recruiting individuals 45 to 75 years with moderate or severe OSA without marked sleepiness and with either established cardiovascular disease (CVD) or at risk for CVD. All participants received standardized CPAP support from a sleep technologist; those randomly assigned to CPAP + ME also received standardized ME delivered by a psychologist during two appointments and six phone calls over 32 weeks. Mixed-effect models with subject-specific intercepts and slopes were fitted to compare objective CPAP adherence between arms, adjusting for follow-up duration, randomization factors, and device manufacturer. All analyses were intention-to-treat.
Overall, 83 participants (n = 42 CPAP only; n = 41 CPAP + ME) contributed 14,273 nights of data for 6 months. Participants were predominantly male (67%) and had a mean ± SD age of 63.9 ± 7.4 years, a BMI of 31.1 ± 5.2 kg/m(2), and an apnea-hypopnea index of 26.2 ± 12.9 events/h. In our fully adjusted model, average nightly adherence for 6 months was 99.0 min/night higher with CPAP + ME compared with CPAP only (P = .003; primary analysis). A subset of 52 participants remained in the study for 12 months; modeling these data yielded a consistent difference in adherence between arms of 97 min/night (P = .006) favoring CPAP + ME.
ME delivered during brief appointments and phone calls resulted in a clinically significant increase in CPAP adherence. This strategy may represent a feasible approach for optimizing management of OSA.
ClinicalTrials.gov; No.: NCT01261390; URL: www.clinicaltrials.gov.
动机增强疗法（ME）显示出有望成为提高阻塞性睡眠呼吸暂停（OSA）患者持续气道正压通气（CPAP）治疗依从性的一种方法。
我们开展了一项开放标签、平行组、随机对照试验，比较单纯CPAP治疗与CPAP + ME治疗的效果，招募年龄在45至75岁之间、患有中度或重度OSA且无明显嗜睡症状、已确诊心血管疾病（CVD）或有CVD风险的个体。所有参与者均接受睡眠技术人员提供的标准化CPAP支持；随机分配至CPAP + ME组的参与者还在32周内的两次门诊和六次电话随访中接受心理学家提供的标准化ME治疗。采用具有个体特异性截距和斜率的混合效应模型，比较两组之间的客观CPAP治疗依从性，并对随访时间、随机化因素和设备制造商进行校正。所有分析均采用意向性分析。
总体而言，83名参与者（单纯CPAP组42名；CPAP + ME组41名）提供了6个月的14273个夜晚的数据。参与者以男性为主（67%），平均年龄±标准差为63.9 ± 7.4岁，体重指数为31.1 ± 5.2 kg/m²，呼吸暂停低通气指数为26.2 ± 12.9次/小时。在我们的完全校正模型中，与单纯CPAP组相比，CPAP + ME组6个月的平均夜间治疗依从性每晚高99.0分钟（P = .003；主要分析）。52名参与者的一个亚组持续参与研究12个月；对这些数据进行建模得出，两组之间的治疗依从性差异持续存在，CPAP + ME组每晚高97分钟（P = .006）。
在简短门诊和电话随访期间实施的ME治疗使CPAP治疗依从性在临床上显著提高。该策略可能是优化OSA管理的一种可行方法。
ClinicalTrials.gov；编号：NCT01261390；网址：www.clinicaltrials.gov。
