Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Trazodone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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