Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
Completed · Phase 3 · Has a placebo group
Conditions studied: Insomnia, End Stage Renal Disease
In brief
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).
Key facts
- Study ID
- NCT03534284
- Run by
- University of Washington
- People needed
- 126
- Starts
- 2018-09-19
- Expected to finish
- 2022-11-17
- Last updated by the study team
- 2024-02-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Undergoing thrice-weekly maintenance hemodialysis for ≥ 3 months
- Able to speak English
- ISI score ≥ 10 at pre-screening with sleep disturbances for ≥ 3 nights per week for ≥ 3 months
You may not qualify if…
- Severe cognitive impairment on Mini-COG cognitive test (score < 3)
- Severe depression assessed by Patient Health Questionnaire (PHQ)-2 and if appropriate, PHQ-9
- Suicidal Ideation
- Alcohol abuse on CAGE alcohol assessment questionnaire (score ≥ 2) or substance abuse on Drug Abuse Screening Test (DAST)-10 questionnaire (score > 5)
- Severe restless leg syndrome
- Treatment with trazodone in the past one month
- Known allergy to trazodone (self-report or by chart review)
- Current treatment with monoamine oxidase inhibitors or in the preceding 14 days
- Current treatment with linezolid (self-report or by chart review)
- Current treatment with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), antipsychotic medications (ziprasidone, chlorpromazine, thioridazine), and quinolone antibiotics
- Pregnancy, or lactation, or women of childbearing potential not willing to use adequate birth control
- Life Expectancy < 3 months
- Expected to receive a kidney transplant or transition to home dialysis (peritoneal dialysis or home hemodialysis) within 6 months
- Any other condition that, in the opinion of the investigator, should preclude patient participation in the clinical trial
Where it is running
- Northwest Kidney Centers — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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