Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (Sleep-HD)

University of Washington

Status and phase: Completed; Phase 3

Conditions: Insomnia; End Stage Renal Disease

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia; Drug: Placebo; Drug: Trazodone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03534284

R01DK115468 (U.S. NIH Grant/Contract)

STUDY00004678

Details and patient eligibility

About

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).

Full description

Most HD patients have significant impairments in quality of life, largely from the high frequency of disabling symptoms. Insomnia is one of the most frequently reported symptoms and studies of HD patients and/or other populations suggest that it is a significant contributor to other common symptoms and poor health outcomes. There are unique contributors to chronic insomnia in HD patients and these include the biologic effects of residual uremia after partial correction as is achieved with current dialysis technology, maladaptation to treatment schedules, and patients' napping during treatments.

There is a compelling need to identify effective treatments for insomnia in HD patients and the interventions being studied in this clinical trial, telehealth cognitive behavioral therapy for insomnia (CBT-I) and trazodone, have a strong scientific premise. If telehealth (web-based) CBT-I is effective for insomnia in HD patients, it will make a treatment that is presently inaccessible available to patients. Trazodone is widely used but the data on efficacy for insomnia are limited; no such data exist for HD patients.

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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 3 patient groups, including a placebo group

CBT-I

Active Comparator group

Description:

Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia

Medication- Trazodone

Active Comparator group

Description:

Trazodone (50-100 mg):

Treatment:

Drug: Trazodone

Medication- Placebo

Placebo Comparator group

Description:

Placebo (for trazodone)

Treatment:

Drug: Placebo