夜眠平衡睡眠体位治疗装置与自动调节正压通气治疗体位性阻塞性睡眠呼吸暂停的比较。
NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea.
机构信息
University of Florida, Gainesville, Florida.
Clayton Sleep Institute, Maplewood, Missouri.
出版信息
J Clin Sleep Med. 2019 Jul 15;15(7):947-956. doi: 10.5664/jcsm.7868.
STUDY OBJECTIVES
Compare treatment efficacy and objective adherence between the NightBalance sleep position treatment (SPT) device and auto-adjusting positive airway pressure (APAP) in patients with exclusive positional obstructive sleep apnea (ePOSA) defined as a supine apnea-hypopnea index (sAHI) ≥ 2 times the nonsupine AHI (nsAHI) and a nsAHI < 10 events/h.
METHODS
This prospective multicenter randomized crossover trial enrolled treatment naive participants with ePOSA (AHI ≥ 15 events/h and nsAHI < 10 events/h) or (AHI > 10 and < 15 events/h with daytime sleepiness and nsAH < 5 events/h). Polysomnography and objective adherence determination (device data) were performed at the end of each 6-week treatment. Patient device preference was determined at the end of the study.
RESULTS
A total of 117 participants were randomized (58 SPT first, 59 APAP first). Of these, 112 started treatment with the second device (adherence cohort) and 110 completed the study (AHI cohort). The AHI on SPT was higher (mean ± standard deviation, 7.29 ± 6.8 versus 3.71 ± 5.1 events/h, < .001). The mean AHI difference (SPT-APAP) was 3.58 events/h with a one sided 95% confidence interval upper bound of 4.96 events/h (< the prestudy noninferiority margin of 5 events/h). The average nightly adherence (all nights) was greater on SPT (345.3 ± 111.22 versus 286.98 ± 128.9 minutes, < .0001). Participants found the SPT to be more comfortable and easier to use and 53% reported a preference for SPT assuming both devices were equally effective.
CONCLUSIONS
Treatment with SPT resulted in non-inferior treatment efficacy and greater adherence compared to APAP in ePOSA suggesting that SPT is an effective treatment for this group.
CLINICAL TRIAL REGISTRATION
Registry: ClinicalTrials.gov; Title: The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea; Identifier: NCT03061071; URL: https://clinicaltrials.gov/ct2/show/NCT03061071.
研究目的
比较 NightBalance 睡眠体位治疗（SPT）设备和自动调节正压通气（APAP）在仰卧位呼吸暂停低通气指数（sAHI）≥ 2 倍非仰卧位 AHI（nsAHI）且 nsAHI＜10 次/小时的特发性位置性阻塞性睡眠呼吸暂停（ePOSA）患者中的治疗效果和客观依从性。
方法
这是一项前瞻性多中心随机交叉试验，招募了特发性位置性阻塞性睡眠呼吸暂停（ePOSA）（AHI≥15 次/小时，nsAHI＜10 次/小时）或（AHI＞10 次/小时且＜15 次/小时，日间嗜睡，nsAH＜5 次/小时）的治疗初治患者。在每 6 周治疗结束时进行多导睡眠图和客观依从性测定（设备数据）。在研究结束时确定患者对设备的偏好。
结果
共有 117 名患者被随机分组（58 名先接受 SPT，59 名先接受 APAP）。其中，112 名患者开始接受第二种设备治疗（依从性队列），110 名患者完成了研究（AHI 队列）。SPT 的 AHI 更高（平均值±标准差，7.29±6.8 次/小时比 3.71±5.1 次/小时，<0.001）。SPT-APAP 的平均 AHI 差值为 3.58 次/小时，单侧 95%置信区间上限为 4.96 次/小时（<研究前非劣效性边界 5 次/小时）。SPT 的平均夜间依从性（所有夜晚）更高（345.3±111.22 分钟比 286.98±128.9 分钟，<0.0001）。参与者认为 SPT 更舒适、更容易使用，53%的人表示如果两种设备同样有效，他们更喜欢 SPT。
结论
与 APAP 相比，SPT 在特发性位置性阻塞性睡眠呼吸暂停患者中的治疗效果非劣效且依从性更高，这表明 SPT 是该人群的有效治疗方法。
临床试验注册
ClinicalTrials.gov；标题：POSAtive 研究：治疗位置性阻塞性睡眠呼吸暂停的研究；标识符：NCT03061071；网址：https://clinicaltrials.gov/ct2/show/NCT03061071。
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