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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Abstract Background 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 laguna 3hp dust collector 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.Methods 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.
Discussion This bostik roll-cote 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.Trial registration NCT03534284 May 23, 2018.SLEEP-HD Protocol Version: 1.3.
4 (7/22/2020).