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