Upper-Airway Stimulation for Obstructive Sleep Apnea
Upper-Airway Stimulation for Obstructive Sleep Apnea
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DOI：
10.1056/nejmoa1308659
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发表时间：
2014-01-09
影响因子：
158.5
通讯作者：
Strohl, Kingman P.
中科院分区：
文献类型：
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作者：
Strollo, Patrick J., Jr.;Soose, Ryan J.;Strohl, Kingman P.
背景阻塞性睡眠呼吸暂停与相当大的健康风险有关。虽然持续气道正压治疗(CPAP)可以减轻这些风险，但疗效可能会因坚持治疗不充分而降低。方法采用多中心、前瞻性、单组、队列设计，对接受或坚持CPAP治疗困难的阻塞性睡眠呼吸暂停患者进行上呼吸道刺激治疗。主要结果指标是呼吸暂停低通气指数(AHI；每小时发生呼吸暂停或低呼吸事件的次数，分数=15，表示中度至重度呼吸暂停)和氧气减饱和指数(ODI；每小时睡眠中血氧水平较基线下降4个百分点的次数)。次要指标为Epworth嗜睡量表、睡眠功能问卷(FOSQ)和血氧饱和度<90%的睡眠时间百分比。有反应的连续参与者被纳入随机对照治疗-停药试验。结果这项研究包括126名参与者，其中83%是男性。平均年龄为54.5岁，平均体重指数(以公斤为单位的体重除以身高以米为单位的平方)为28.4。12个月时AHI评分的中位数从29.3次/小时下降到9.0次/小时，下降了68%(P
BACKGROUNDObstructive sleep apnea is associated with considerable health risks. Although continuous positive airway pressure (CPAP) can mitigate these risks, effectiveness can be reduced by inadequate adherence to treatment. We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea.METHODSUsing a multicenter, prospective, single-group, cohort design, we surgically implanted an upper-airway stimulation device in patients with obstructive sleep apnea who had difficulty either accepting or adhering to CPAP therapy. The primary outcome measures were the apnea-hypopnea index (AHI; the number of apnea or -hypopnea events per hour, with a score of >= 15 indicating moderate-to-severe apnea) and the oxygen desaturation index (ODI; the number of times per hour of sleep that the blood oxygen level drops by >= 4 percentage points from baseline). Secondary outcome measures were the Epworth Sleepiness Scale, the Functional Outcomes of Sleep Questionnaire (FOSQ), and the percentage of sleep time with the oxygen saturation less than 90%. Consecutive participants with a response were included in a randomized, controlled therapy-withdrawal trial.RESULTSThe study included 126 participants; 83% were men. The mean age was 54.5 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 28.4. The median AHI score at 12 months decreased 68%, from 29.3 events per hour to 9.0 events per hour (P