Abstract: TH-PO1135
Short- and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (SLEEP-HD)
Session Information
- Late-Breaking Posters
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Mehrotra, Rajnish, University of Washington, Seattle, Washington, United States
- Cukor, Daniel, Rogosin Institute, New York, New York, United States
- Mccurry, Susan M., University of Washington, Seattle, Washington, United States
- Rue, Tessa, University of Washington, Seattle, Washington, United States
- Roumelioti, Maria-Eleni, University of New Mexico School of Medicine, Albuquerque, New Mexico, United States
- Heagerty, Patrick James, University of Washington, Seattle, Washington, United States
- Unruh, Mark L., University of New Mexico School of Medicine, Albuquerque, New Mexico, United States
Background
Nearly 50% of patients undergoing in-center hemodialysis report chronic insomnia, yet efficacy and safety of treatments is not known. This trial tested the comparative effectiveness of cognitive behavioral therapy for insomnia (CBT-I), trazodone, and placebo for insomnia in this population.
Methods
We undertook a randomized, multicenter, double-blinded, placebo-controlled trial in 26 dialysis units. Patients undergoing in-center hemodialysis with insomnia severity index (ISI) score ≥ 10 and sleep disturbances on ≥ 3 nights/week for ≥ 3 months were randomized 1:1:1 to 6-week treatment with telehealth CBT-I or trazodone or placebo. The primary outcome was the ISI score at 7- and 25-weeks.
Results
923 patients were pre-screened, 411 had insomnia, and 126 were randomized to CBT-I (n=43), trazodone (n=42), or placebo (n=41). The ISI scores decreased in each group: CBT-I (baseline mean ± SD, 16.1 ± 4.8; 7-weeks, 12.3 ± 6.0), trazodone (baseline mean ± SD, 17.2 ± 5.4; 7-weeks, 12.5 ± 6.2), and placebo (baseline mean ± SD, 15.2 ± 4.4; 7-weeks 12.5 ± 5.3) and there was no significant difference in the average 7-week scores across groups. There was no meaningful difference in ISI scores at 25-weeks. There was no significant difference in other patient-reported outcomes at any time point, or use of sleeping aids, or with actigraphy. Serious adverse events, particularly cardiovascular hospitalizations, were more frequent with trazodone (Relative risk: trazodone vs. CBT-I, 12.2 (1.83, 519.2); trazodone vs. placebo, 3.1 (0.97-13.22)).
Conclusion
In patients undergoing in-center hemodialysis with chronic insomnia, there was no meaningful difference in the short- or long-term effectiveness of CBT-I or trazodone compared with placebo. Participants receiving trazodone had higher incidence of serious adverse events.
Funding
- NIDDK Support