Sleep in Cardiac patients with Implantable Cardioverter Defibrillators (ICD)

描述（由研究者提供）：在美国，心脏病是导致死亡的主要原因。由于植入式心律转复除颤器（ICD）显著降低了心脏死亡率，每年大约有20万个ICD被植入。在57%的ICD患者中，睡眠障碍是一种重要的合并症，这可能会给本已脆弱的患者群体带来各种负面后果（生活质量下降、事故）。不幸的是，关于所经历的睡眠障碍的具体类型的信息是不可获得的。这些信息很重要，因为不同的睡眠障碍需要非常不同的治疗方法。具体目标1通过使用[3阶段]过程来鉴别诊断ICD患者的睡眠障碍来解决这个问题：1-临床访谈；2-polysomnography;3-sleep日记。阻塞性睡眠呼吸暂停（OSA）和失眠可能是ICD患者中最常见的两种睡眠障碍。阻塞性睡眠呼吸暂停有有效的治疗方法。然而，这些患者失眠的最佳治疗方法尚不清楚。睡眠药物提供有效的短期缓解，但可能不是最好的方法慢性失眠的ICD患者。认知行为治疗失眠（CBTi）是一种有吸引力的治疗选择，因为它有效，几乎没有不良影响的风险，并且大多数患者更喜欢睡眠药物。不幸的是，由于这些患者通常被排除在行为干预方案之外，因此无法得出关于CBTi对ICD患者有效性的明确结论。具体目标2和3涉及一项随机临床试验（RCT），以评估短期认知行为干预对ICD失眠患者候补名单控制的睡眠（目标2）和其他白天结果（目标3）的影响。将开发一个简短的多组分CBTi方案，其中包括治疗失眠的既定行为方法，以及针对与心脏病和ICD植入相关的负面认知和焦虑的几个新组分。患有失眠的ICD患者将被随机分配到治疗组或候补组。治疗将分为2次“面对面”治疗和2次“电话”治疗。睡眠和其他结果（心理功能、日间功能、生活质量、心脏功能（心律失常负担））以及ICD调整将在基线、治疗后和3个月随访时进行评估。在心脏病和ICD植入的背景下，睡眠障碍是许多美国人的主要健康威胁。这项研究解决了对ICD患者所经历的睡眠障碍类型信息的公共卫生需求，以及针对这一弱势群体失眠的行为干预措施的发展。所获得的信息不仅对其他可能患有失眠（即慢性疼痛）的患者群体有广泛的影响，而且对那些患有其他行为/健康问题（即体重管理，抑郁症）的患者也有广泛的影响。

DESCRIPTION (provided by investigator): Cardiac disease is the leading cause of death in the U.S. Because the Implantable Cardioverter Defibrillator (ICD) significantly reduces cardiac mortality, approximately 200,000 ICDs are implanted each year. Sleep disturbance represents a significant comorbidity for ~57 percent of ICD patients, potentially contributing to a variety of negative consequences (decreased quality of life, accidents) in this already vulnerable patient population. Unfortunately, information regarding the specific types of sleep disturbance experienced is not available. Such information is important, because different sleep disorders require very different treatment approaches. Specific Aim 1 addresses this issue by using a [3 stage] process to differentially diagnose sleep disorders in ICD patients: 1-clinical interview; 2-polysomnography; 3-sleep diaries. Obstructive sleep apnea (OSA) and insomnia are likely to be the two most common sleep disorders in ICD patients. Effective treatment exists for OSA. However, the best treatment approach for insomnia in these patients is unclear. Sleep medications provide effective short-term relief, but may not the best approach for chronic insomnia in ICD patients. Cognitive behavioral therapy for insomnia (CBTi) represents an attractive treatment alternative, because it is effective, carries little risk of unwanted effects, and is preferred to sleep medication by the majority of patients. Unfortunately, no definitive conclusions can be drawn about CBTi's effectiveness in ICD patients, because these patients are typically excluded from behavioral intervention protocols. Specific Aims 2 and 3 involve a randomized clinical trial (RCT) to evaluate the effects on sleep (Aim 2) and other daytime outcomes (Aim 3) of a brief cognitive-behavioral intervention against a waitlist control in ICD patients with insomnia. A brief, multiple-component CBTi protocol will be developed that includes established behavioral approaches to treating insomnia plus several novel components to target the negative cognitions and anxieties associated with cardiac disease and ICD implantation. ICD patients with insomnia will be randomly assigned to either treatment or a waitlist control. Treatment will be individually administered during 2 `in-person' sessions & 2 `telephone' sessions. Sleep and other outcomes (psychological functioning, daytime functioning, [quality of life, cardiac functioning (arrhythmic burden)], and ICD adjustment will be evaluated at baseline, post treatment, & 3 month follow-up. Sleep disturbance in the context of cardiac disease and ICD implantation represents a major health threat for many Americans. This research addresses the public health need for information on the types of sleep disorders experienced by ICD patients and for the development of behavioral interventions that target insomnia in this vulnerable population. The information to be gained has broad implications not only for other patient populations likely to suffer from insomnia (i.e., chronic pain), but also for those suffering from other behavioral/heath concerns (i.e., weight management, depression). PUBLIC HEALTH RELEVANCE: Sleep disturbance in the context of cardiac disease and ICD implantation represents a major health threat for many Americans. This research addresses the public health need for information on the types of sleep disorders experienced by ICD patients and for the development of behavioral interventions that target insomnia in this vulnerable population. The information to be gained has broad implications not only for other patient populations likely to suffer from insomnia (i.e., chronic pain), but also for those suffering from other behavioral/heath concerns (i.e., weight management, depression).