Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis.
Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis.
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DOI：
10.1186/s12882-020-02107-x
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发表时间：
2020-10-20
期刊：
影响因子：
2.3
通讯作者：
Mehrotra R
中科院分区：
文献类型：
--
作者：
Unruh M;Cukor D;Rue T;Abad K;Roumelioti ME;McCurry SM;Heagerty P;Mehrotra R
接受血液透析（HD）治疗的终末期肾病（ESKD）患者会出现许多令人痛苦的症状。一种常见的症状是失眠。关于HD治疗和时间表存在独特的问题，这些问题会扰乱正常的睡眠/觉醒习惯，并可能导致失眠的严重程度。尽管有证据表明失眠对健康有广泛的影响，但很少有临床试验测试HD患者治疗的疗效。失眠的认知行为疗法（CBT-I）是一种推荐的一线疗法，但在美国，HD患者基本上无法使用，部分原因是他们每周三次透析治疗的时间相当长。另一个重要原因可能是在透析中心提供行为健康护理的后勤和报销挑战。通过远程保健提供的CBT-I可以克服获得的障碍，但其疗效从未对这些患者进行过严格的测试。药物治疗是最广泛使用的失眠治疗;然而，目前使用的一些药物是不安全的，因为它们与HD患者的较高死亡风险相关（苯二氮卓类和唑吡坦类药物）。其他药物（曲唑酮）治疗失眠的疗效和安全性从未在HD患者中进行过测试。这项试验测试了6周远程健康CBT-I，曲唑酮或药物安慰剂治疗的短期和长期比较有效性。这将通过一项随机对照试验（RCT）来实现，其中126名在社区透析机构接受HD治疗的慢性失眠受试者将按1：1：1的比例分别分配到远程健康CBT-I、曲唑酮或药物安慰剂组;每个治疗组的短期有效性将在6周治疗结束时确定，长期有效性将在25周时确定。主要和次要患者报告结局将由对治疗分配设盲的研究科学家通过基于计算机的电话访谈进行评估;其他次要结局将通过受试者访谈和腕动记录进行评估。本临床RCT将首次提供证据，证明两种不同方法治疗慢性失眠和接受维持性HD患者的其他患者报告结局的有效性比较。NCT 03534284 2018年5月23日。SLEEP-HD方案版本：1.3.4（2020年7月22日）。
Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD. This trial tests 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 trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy. This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD. NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020).
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影响因子：
120.7
作者：
Edinger, JD;Wohlgemuth, WK;Quillian, RE
通讯作者：
Quillian, RE
影响因子：
5.6
作者：
Guthrie, Katherine A.;Larson, Joseph C.;McCurry, Susan M.
通讯作者：
McCurry, Susan M.
影响因子：
5.6
作者：
Espie, Colin A.;MacMahon, Kenneth M. A.;Wilson, Philip
通讯作者：
Wilson, Philip
影响因子：
5.6
作者：
Espie, Colin A.;Kyle, Simon D.;Brown, June S. L.
通讯作者：
Brown, June S. L.
DOI：
10.2215/cjn.10850917
发表时间：
2018-05-07
影响因子：
9.8
作者：
Flythe, Jennifer E.;Hilliard, Tandrea;Mehrotra, Rajnish
通讯作者：
Mehrotra, Rajnish