Treatment Options for Insomnia for ESRD

项目总结/摘要 接受血液透析（HD）治疗的终末期肾病患者报告健康相关生活质量较差， 部分原因是他们经历了大量令人不安的症状。最常被报道的 这些症状是失眠，包括患者难以入睡，经常在跌倒后醒来， 睡了，清晨醒来。有一些与HD治疗和时间表有关的独特问题， 扰乱了正常的睡眠/觉醒习惯，并导致失眠的高患病率和严重程度。大 来自HD患者和其他人群的大量证据也表明失眠与疲劳有关， 白天嗜睡，疼痛，抑郁症状，死亡风险更高。尽管有广泛的证据- 尽管失眠对健康的影响范围很广，但还没有临床试验测试过对HD患者治疗的效果。 失眠的认知行为疗法（CBT-I）被推荐为一线疗法，但无法获得。 美国的血液透析患者，因为他们必须在社区接受每周三次的透析治疗， 基于透析设施;远程医疗提供的CBT-I可以克服障碍，但其功效从未 对任何患者群体进行了严格的测试。药物治疗是最广泛使用的治疗方法， HD患者的失眠-虽然目前使用的一些药物是不安全的，因为它们与更高的 该患者人群的死亡风险（苯二氮卓类和唑吡坦类药物），其他药物的疗效 （曲唑酮）从未在HD患者中进行过试验。在这个应用程序中，我们建议测试短和 远程健康CBT-I、曲唑酮或药物治疗6周的长期比较有效性 安慰剂这将通过一项随机对照临床试验来实现，在该试验中， 在西雅图和阿尔伯克基的社区透析机构治疗的慢性失眠症将被分配到 2：2：1远程保健CBT-I，曲唑酮和药物安慰剂，分别;短期有效性将是 在6周治疗结束时确定，在24周时确定长期有效性。远程保健CBT-I将 由英语和西班牙语治疗师通过移动的平台iHOPE提供服务。主要和 将通过基于计算机的电话访谈评估次要患者报告的结局， 研究科学家对治疗分配不知情。该研究将在高度监督下进行。 在西雅图有经验丰富的临床和数据协调中心，在患者入组方面有良好的记录 并保留在临床试验中，并实施行为干预与高度忠实的协议。这 临床试验将为两种不同方法的比较有效性提供第一个证据， 改善HD患者的失眠和其他患者报告的结局。这也将是第一个严格的 远程医疗CBT-I评价，一种不仅适用于HD患者而且适用于其他患者的可扩展方法 难以获得失眠治疗的人群。

Project Summary/Abstract Patients with end-stage renal disease treated with hemodialysis (HD) report poor health-related quality life, in part because of the large number of troubling symptoms they experience. One of the most frequently reported such symptom is insomnia and includes patients' difficulties in falling asleep, frequently waking up after falling asleep, and early morning awakening. There are unique issues pertaining to HD treatments and schedules that disrupt regular sleep/wake routines and contribute to the high prevalence and severity of insomnia. A large body of evidence from HD patients and other populations also indicate that insomnia is associated with fatigue, daytime sleepiness, pain, depressive symptoms, and a higher risk for death. Despite evidence for broad- ranging health effects of insomnia, no clinical trials have tested the efficacy of treatments for HD patients. Cognitive behavioral therapy for insomnia (CBT-I) is recommended as first line therapy but is inaccessible to HD patients in the United States as they have to commit to thrice weekly dialysis treatments in community- based dialysis facilities; CBT-I delivered by telehealth can overcome the barriers but its efficacy has never been rigorously tested for any patient population. Pharmacotherapy is the most widely used treatment for insomnia for HD patients - while some drugs presently used are unsafe as they are associated with a higher risk for death for this patient population (benzodiazepines and zolpidem-like drugs), the efficacy of others (trazodone) has never been tested for HD patients. With this application, we propose to test the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled clinical trial in which 125 HD patients with chronic insomnia treated in community-based dialysis facilities in Seattle and Albuquerque will be assigned 2:2:1 to telehealth CBT-I, trazodone, and medication placebo, respectively; short-term effectiveness will be determined at the end of 6-weeks of treatment and long-term effectiveness at 24-weeks. Telehealth CBT-I will be delivered through a mobile platform, iHOPE, by English and Spanish-speaking therapists. The primary and secondary patient reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment. The study will be conducted under the oversight of highly experienced Clinical and Data Coordinating Centers in Seattle with a strong track record of patient enrollment and retention in clinical trials, and implementing behavioral interventions with high fidelity to the protocol. This clinical trial will provide the first evidence for the comparative effectiveness of two distinct approaches in improving insomnia and other patient-reported outcomes for HD patients. It will also be the first rigorous evaluation of telehealth CBT-I, a readily scalable approach not only for HD patients but also for other patient populations with difficulty accessing treatment for insomnia.