Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
Condition: Insomnia; End Stage Renal Disease
MeSH terms: Sleep Initiation and Maintenance Disorders; Kidney Failure, Chronic
Intervention: Cognitive Behavioral Therapy for Insomnia; Trazodone; Placebo
Intervention description: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.; trazodone tablet; Inactive pill manufactured to mimic trazodone tablets.
Intervention MeSH terms: Trazodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SLEEP-HD is a parallel group randomized controlled trial wherein 125 HD patients with chronic insomnia, treated in community-based dialysis facilities in Seattle and Albuquerque, will be randomized 1:1:1 over 31 months to 6-week treatment with telehealth CBT-I, trazodone, or medication placebo.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The investigator, the participant, and the care provider will be blinded to the drug assignment (trazodone vs. placebo) for those subjects randomized into the medication intervention arm.
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemodialysis; Kidney disease; Trazodone; Cognitive behavioral therapy

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).
    

Eligibility 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