Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
Insomnia is a common and distressing symptom for patients on hemodialysis (HD), and there is
evidence for a much larger impact on the health of patients. Chronic insomnia is disrupted
sleep that occurs at least three nights per week and lasts at least three months.
The SLEEP-HD study is a randomized open-label clinical trial to compare two types of
treatment for insomnia in participants who have end-stage renal disease on HD, and who have
been diagnosed with chronic insomnia. The two types of treatment involved in the study are
Cognitive Behavioral Therapy for Insomnia (CBT-I) or treatment with a drug (trazodone vs
placebo).
126 participants will be enrolled who are undergoing HD in two study locations (Seattle,
Washington and Albuquerque, New Mexico).
Phase:
Phase 3
Details
Lead Sponsor:
University of Washington
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)