Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans

描述(由申请人提供)： 阻塞性睡眠呼吸暂停(OSA)是一种以睡眠期间反复发作的完全或部分上呼吸道阻塞为特征的疾病。OSA的患病率随着年龄的增长而增加，并与心血管疾病风险增加、生活质量下降和死亡率增加有关。失眠的患病率也随着年龄的增长而增加，并与许多不良后果有关，包括生活质量下降、医疗费用增加和死亡率增加。失眠的诊断标准包括入睡或保持睡眠的能力降低，夜间频繁醒来或睡眠质量差，与白天的损害有关，如疲劳、注意力减退或白天嗜睡。最近的证据表明，失眠经常与阻塞性睡眠呼吸暂停共存，尤其是在老年人中，并预示着阻塞性睡眠呼吸暂停更糟糕的结果。与普通人群相比，退伍军人中阻塞性睡眠呼吸暂停综合症和失眠的患病率更高。对大量同时患有阻塞性睡眠呼吸暂停综合征和失眠的患者的最佳治疗方法知之甚少。最佳实践指南通常单独处理这些情况，其中气道正压(PAP)治疗是治疗阻塞性睡眠呼吸暂停综合征的标准，而认知行为疗法(CBT-I)被认为是慢性失眠的一线治疗。事实上，大多数CBT-I试验排除了有阻塞性睡眠呼吸暂停综合征证据的参与者，并且大多数PAP治疗试验没有解决共存的失眠问题。CBT-I特别推荐用于老年人失眠，因为在老年人中，安眠药的副作用最成问题。OSA患者对PAP治疗的依从率非常低(特别是在退伍军人中)，同时存在失眠预示着对PAP的依从性较低。几项研究表明，早期坚持PAP治疗(即阻塞性睡眠呼吸暂停患者在治疗早期坚持PAP治疗的程度)是长期坚持PAP的最有力预测因素之一。不幸的是，在许多患者中，一旦OSA被确定并开始PAP治疗，失眠症状要么根本不被解决，要么只有在患者建立了长期不遵守PAP的模式后才被考虑。基于这一证据，以及我们自己大量前期工作的发现，我们认为，需要一种新颖的、综合的、行为治疗方法，在PAP治疗过程的早期解决OSA和失眠问题，以在这些条件共存的情况下最大限度地提高患者的依从性和治疗成功率。我们提出了一项随机对照试验来测试一种新的行为方法，该方法在被诊断为阻塞性睡眠呼吸暂停综合征的老年退伍军人(60岁，N=120)中整合了最佳实践，他们被开出了PAP治疗处方，并伴有失眠。参与者将在退伍军人中招募，这些退伍军人被转介到退伍军人管理局大洛杉矶医疗系统的睡眠诊所，他们被诊断为OSA和开出的PAP疗法，并且也符合失眠的诊断标准。这项干预将结合CBT-I和行为PAP遵守计划，该计划由盟军卫生人员提供，并在PAP治疗的早期启动。被随机分配到控制条件的参与者将接受积极的注意力控制计划，包括一般睡眠和OSA教育。我们的具体目标是测试这种结合的CBT-I和行为PAP干预是否改善了患有OSA和共病失眠的老年退伍军人的睡眠、PAP依从性、情绪和健康相关的生活质量。我们还将探讨参与者的经验、态度和对干预的关键方面的坚持，这些方面可能会成为未来将干预落实到常规临床护理中的潜在促进者或障碍。

DESCRIPTION (provided by applicant): Obstructive sleep apnea (OSA) is a disorder characterized by repetitive episodes of complete or partial upper airway obstruction occurring during sleep. OSA increases in prevalence with age, and is associated with increased risk of cardiovascular disease, decreased quality of life, and increased mortality. Insomnia also increases in prevalence with age, and is associated with numerous adverse outcomes, including decreased quality of life, increased healthcare costs and increased mortality. The diagnostic criteria for insomnia include a decreased ability to fall asleep or stay asleep, frequent nighttime awakening or poor quality sleep that is associated with daytime impairment such as fatigue, impaired attention, or daytime sleepiness. Recent evidence suggests that insomnia often coexists with OSA, particularly in older adults, and predicts worse outcomes of OSA. Both OSA and insomnia have an even higher prevalence among Veterans compared to the general population. Little is known of the best approaches to manage the large number of patients with coexisting OSA and comorbid insomnia. Guidelines for best practice typically address these conditions separately, where positive airway pressure (PAP) therapy is the standard for the treatment of OSA, and cognitive behavioral therapy for insomnia (CBT-I) is considered first-line treatment for chronic insomnia. In fact, most CBT-I trials have excluded participants with evidence of OSA, and most PAP treatment trials do not address coexisting insomnia. CBT-I is particularly recommended for insomnia in older adults, where adverse effects of sleeping medications are most problematic. Adherence rates to PAP therapy in patients with OSA are very low (particularly among Veterans), and coexisting insomnia predicts lower adherence with PAP. Several studies have demonstrated that early adherence to PAP therapy (i.e., how adherent the OSA patient is with PAP therapy early in the course of treatment) is one of the strongest predictors of long-term PAP adherence. Unfortunately, in many patients, once OSA is identified and PAP therapy initiated, insomnia symptoms are either not addressed at all, or are only considered once the patient has established a long-term pattern of nonadherence with PAP. Based on this evidence, and findings from our own extensive prior work, we believe that a novel, integrated, behavioral treatment approach which addresses both OSA and insomnia early in the course of PAP therapy is needed to maximize patient adherence and treatment success when these conditions coexist. We propose a randomized controlled trial to test a novel, behavioral approach integrating best practices among older Veterans (aged > 60 years, N=120) diagnosed with OSA who are prescribed PAP therapy and have comorbid insomnia. Participants will be recruited among older Veterans referred to sleep clinics in the VA Greater Los Angeles Healthcare System who are diagnosed with OSA and prescribed PAP therapy, and also meet diagnostic criteria for insomnia. The intervention will combine CBT-I with a behavioral PAP adherence program, provided by allied health personnel and initiated early during PAP treatment. Participants randomized to the control condition will receive an active, attention control program including general sleep and OSA education. Our specific aims are to test whether this combined, integrated CBT-I and behavioral PAP intervention improves sleep, PAP adherence, mood and health-related quality of life among older Veterans with OSA and comorbid insomnia. We will also explore participants' experiences, attitudes and adherence with key aspects of the intervention, which may act as potential facilitators or barriers to future implementation of the intervention into routine clinical care.