Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Oct 20;21(1):443.
doi: 10.1186/s12882-020-02107-x.

Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis

Mark Unruh  1   2 , Daniel Cukor  3 , Tessa Rue  4 , Kashif Abad  5 , Maria-Eleni Roumelioti  5 , Susan M McCurry  6 , Patrick Heagerty  4 , Rajnish Mehrotra  7
Affiliations

Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis

Mark Unruh et al. BMC Nephrol. .

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 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 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).

Keywords: Actigraphy; Cognitive behavioral therapy; Computer-based telephone interview; Hemodialysis; Insomnia; Telehealth; Trazodone.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests. Funding/assistance was not received from a commercial organization.

Figures

Fig. 1
Fig. 1
Study overview
See this image and copyright information in PMC

References

    1. Saran R, Robinson B, Abbott KC, Agodoa LYC, Bhave N, Bragg-Gresham J, et al. US renal data system 2017 annual data report: epidemiology of kidney disease in the United States. Am J Kidney Dis. 2018;71(3 Suppl 1):A7. - PMC - PubMed
    1. Wang R, Tang C, Chen X, Zhu C, Feng W, Li P, et al. Poor sleep and reduced quality of life were associated with symptom distress in patients receiving maintenance hemodialysis. Health Qual Life Outcomes. 2016;14(1):125. - PMC - PubMed
    1. Elder SJ, Pisoni RL, Akizawa T, Fissell R, Andreucci VE, Fukuhara S, et al. Sleep quality predicts quality of life and mortality risk in haemodialysis patients: results from the Dialysis outcomes and practice patterns study (DOPPS) Nephrol Dial Transplant. 2008;23(3):998–1004. - PubMed
    1. Anand S, Johansen KL, Grimes B, Kaysen GA, Dalrymple LS, Kutner NG, et al. Physical activity and self-reported symptoms of insomnia, restless legs syndrome, and depression: the comprehensive dialysis study. Hemodial Int. 2013;17(1):50–58. - PMC - PubMed
    1. Flythe JE, Hilliard T, Lumby E, Castillo G, Orazi J, Abdel-Rahman EM, et al. Fostering Innovation in Symptom Management among Hemodialysis Patients: Paths Forward for Insomnia, Muscle Cramps, and Fatigue. Clin J Am Soc Nephrol. 2019;14(1):150–160. - PMC - PubMed

Publication types

MeSH terms

Associated data