Sleep in Cardiac patients with Implantable Cardioverter Defibrillators (ICD)

描述（由研究者提供）：心脏病是美国的主要死亡原因。由于植入式心律转复除颤器（ICD）显著降低了心源性死亡率，每年约植入200，000例ICD。睡眠障碍是约57%的ICD患者的一种显著合并症，可能导致这一已经脆弱的患者人群的各种负面后果（生活质量下降，意外事件）。不幸的是，关于所经历的特定类型的睡眠障碍的信息是不可用的。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-多导睡眠图; 3-睡眠日记。阻塞性睡眠呼吸暂停（OSA）和失眠可能是ICD患者最常见的两种睡眠障碍。有效治疗OSA。然而，这些患者失眠的最佳治疗方法尚不清楚。睡眠药物提供了有效的短期缓解，但可能不是ICD患者慢性失眠的最佳方法。失眠的认知行为疗法（CBTi）是一种有吸引力的治疗选择，因为它是有效的，几乎没有不良反应的风险，并且大多数患者首选睡眠药物。不幸的是，无法得出关于CBTi在ICD患者中的有效性的明确结论，因为这些患者通常被排除在行为干预方案之外。具体目标2和3涉及一项随机临床试验（RCT），以评估ICD失眠患者中短暂认知行为干预对睡眠（目标2）和其他日间结局（目标3）的影响，而等待名单对照。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几个新组分，以针对与心脏病和ICD植入相关的负面认知和焦虑。患有失眠症的ICD患者将被随机分配到治疗组或等待名单对照组。治疗将在2个“面对面”会议和2个“电话”会议期间单独管理。将在基线、治疗后和3个月随访时评估睡眠和其他结局（心理功能、日间功能、[生活质量、心脏功能（心脏负担）]和ICD调整。心脏病和ICD植入背景下的睡眠障碍是许多美国人的主要健康威胁。这项研究解决了公共卫生需要ICD患者经历的睡眠障碍类型的信息，并针对这一弱势群体的失眠症的行为干预措施的发展。所获得的信息不仅对可能患有失眠症的其他患者群体（即，慢性疼痛），而且对于那些患有其他行为/健康问题的人（即，体重管理、抑郁症）。 公共卫生相关性：心脏病和ICD植入背景下的睡眠障碍是许多美国人的主要健康威胁。这项研究解决了公共卫生需要ICD患者经历的睡眠障碍类型的信息，并针对这一弱势群体的失眠症的行为干预措施的发展。所获得的信息不仅对可能患有失眠症的其他患者群体（即，慢性疼痛），而且对于那些患有其他行为/健康问题的人（即，体重管理、抑郁症）。

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).