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采用不完全析因设计评估阻塞性睡眠呼吸暂停伴失眠障碍的治疗效果。

Evaluating the treatment of obstructive sleep apnea comorbid with insomnia disorder using an incomplete factorial design.

机构信息

Rush University Medical Center, 1653 W. Congress Parkway, Chicago, IL 60612-3833, United States.

Rush University Medical Center, 1653 W. Congress Parkway, Chicago, IL 60612-3833, United States.

出版信息

Contemp Clin Trials. 2016 Mar;47:146-52. doi: 10.1016/j.cct.2015.12.017. Epub 2015 Dec 28.

Abstract

Chronic insomnia disorder is a prevalent condition and a significant proportion of these individuals also have obstructive sleep apnea (OSA). These two sleep disorders have distinct pathophysiology and are managed with different treatment approaches. High comorbidity rates have been a catalyst for emerging studies examining multidisciplinary treatment for OSA comorbid with insomnia disorder. In this article, we describe a randomized clinical trial of cognitive behavioral treatment for insomnia (CBT-I) and positive airway pressure (PAP) for OSA. Participants are randomized to receive one of three treatment combinations. Individuals randomized to treatment Arm A receive sequential treatment beginning with CBT-I followed by PAP, in treatment Arm B CBT-I and PAP are administered concurrently. These treatment arms are compared to a control condition, treatment Arm C, where individuals receive PAP alone. Adopting an incomplete factorial study design will allow us to evaluate the efficacy of multidisciplinary treatment (Arms A & B) versus standard treatment alone (Arm C). In addition, the random allocation of individuals to the two different combined treatment sequences (Arm A and Arm B) will allow us to understand the benefits of the sequential administration of CBT-I and PAP relative to concurrent treatment of PAP and CBT-I. These findings will provide evidence of the clinical benefits of treating insomnia disorder in the context of OSA.

摘要

慢性失眠障碍是一种普遍存在的疾病,其中相当一部分人还患有阻塞性睡眠呼吸暂停(OSA)。这两种睡眠障碍具有不同的病理生理学机制,需要采用不同的治疗方法。高共病率一直是新兴研究的催化剂,这些研究旨在探讨 OSA 合并失眠障碍的多学科治疗方法。在本文中,我们描述了一项认知行为治疗失眠症(CBT-I)和正压通气(PAP)治疗 OSA 的随机临床试验。参与者被随机分配到三种治疗组合中的一种。随机分配到治疗臂 A 的个体首先接受 CBT-I 治疗,然后接受 PAP 治疗;随机分配到治疗臂 B 的个体同时接受 CBT-I 和 PAP 治疗。这些治疗臂与单独接受 PAP 治疗的对照组(治疗臂 C)进行比较。采用不完全因子设计研究方案将使我们能够评估多学科治疗(臂 A 和臂 B)与单独标准治疗(臂 C)的疗效。此外,将个体随机分配到两种不同的联合治疗序列(臂 A 和臂 B)将使我们能够了解 CBT-I 和 PAP 的序贯给药相对于 PAP 和 CBT-I 的同时治疗的益处。这些发现将为在 OSA 背景下治疗失眠症的临床益处提供证据。

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