University of Utah College of Nursing and School of Medicine, Salt Lake City, UT, USA.
Sleep. 2010 Feb;33(2):260-6. doi: 10.1093/sleep/33.2.260.
To evaluate the use of sham-continuous positive airway pressure (CPAP) treatment as a placebo intervention.
Analysis of polysomnograms performed in fixed order without sham-CPAP and on the first night of the sham-CPAP intervention in participants in the CPAP Apnea Trial North American Program (CATNAP), a randomized, placebo controlled trial evaluating the effects of CPAP treatment on daytime function in adults with newly diagnosed mild to moderate obstructive sleep apnea (apnea hypopnea index (AHI) 5-30).
The first 104 CATNAP participants randomized to the sham-CPAP intervention arm.
Compared to the polysomnographic measures without sham-CPAP, the study on the first night with sham-CPAP had statistically significant differences that suggested a decrease in sleep quality: decreased sleep efficiency, increased arousal index, increased time in stage 1 NREM sleep, and prolonged latency to REM sleep. However, all of these differences had a relatively small effect size. Compared to the polysomnogram without sham-CPAP, the number of hypopneas on the sham-CPAP polysomnogram was significantly increased and the number of apneas significantly decreased. Relatively minor differences in AHI with and without sham-CPAP were present and were dependent on the criteria used to score hypopneas.
Comparison of polysomnograms with and without sham-CPAP revealed differences that, although statistically significant, were small in magnitude and had relatively low effect sizes suggesting minimal clinical significance. The results support the use of sham-CPAP as a placebo intervention in trials evaluating the effects of CPAP treatment in patients with obstructive sleep apnea.
This paper was a secondary analysis of clinical trial data. CATNAP: CPAP Apnea Trial North American Program, the trial from which the data were obtained, is registered with clinicaltrial.gov. Registration #NCT00089752.
评估假持续气道正压通气（CPAP）治疗作为安慰剂干预的效果。
对 CPAP 呼吸暂停试验北美计划（CATNAP）参与者进行的固定顺序多导睡眠图分析，无假 CPAP 分析和假 CPAP 干预的第一晚。该研究是一项随机、安慰剂对照试验，评估 CPAP 治疗对新诊断为轻度至中度阻塞性睡眠呼吸暂停（呼吸暂停低通气指数（AHI）5-30）成人日间功能的影响。
随机分配到假 CPAP 干预组的 CATNAP 前 104 名参与者。
与无假 CPAP 的多导睡眠图测量相比，假 CPAP 第一晚的研究具有统计学意义的差异，表明睡眠质量下降：睡眠效率降低，觉醒指数增加，NREM 睡眠 1 期时间增加，REM 睡眠潜伏期延长。然而，所有这些差异的效应量都相对较小。与无假 CPAP 的多导睡眠图相比，假 CPAP 多导睡眠图中的呼吸暂停次数明显增加，呼吸暂停次数明显减少。有无假 CPAP 的 AHI 相对较小的差异，并且取决于用于评分呼吸暂停的标准。
比较有无假 CPAP 的多导睡眠图显示，尽管具有统计学意义，但差异幅度较小，效应量相对较低，表明临床意义最小。结果支持在评估 CPAP 治疗对阻塞性睡眠呼吸暂停患者疗效的试验中使用假 CPAP 作为安慰剂干预。
本文是临床试验数据的二次分析。CATNAP：CPAP 呼吸暂停试验北美计划，该试验的数据来源于该试验，在 clinicaltrial.gov 注册。注册号：NCT00089752。
