Clinical trial NCT03534284: Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
Official title: Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (Sleep-HD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
End Stage Renal Disease
Keywords: Hemodialysis
Kidney disease
Trazodone
Cognitive behavioral therapy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-05-23
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

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

Primary outcomes:
measure: Insomnia Severity Index (ISI) Short-term
timeFrame: Week 7
measure: Insomnia Severity Index (ISI) Long-term
timeFrame: Week 25
Secondary outcomes:
measure: Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term
timeFrame: Week 7
measure: Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term
timeFrame: Week 25
measure: Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term
timeFrame: Week 7
measure: Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term
timeFrame: Week 25
measure: Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term
timeFrame: Week 7
measure: Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term
timeFrame: Week 25
measure: Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term
timeFrame: Week 7
measure: Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term
timeFrame: Week 25
measure: Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term
timeFrame: Week 7
measure: Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term
timeFrame: Week 25
measure: Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term
timeFrame: Week 7
measure: Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term
timeFrame: Week 25
measure: Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term
timeFrame: Week 7
measure: Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term
timeFrame: Week 25
measure: Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term
timeFrame: Week 7
measure: Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term
timeFrame: Week 25
measure: Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term
timeFrame: Week 7
measure: Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term
timeFrame: Week 25
measure: Cumulative Weekly Use of Sedatives/Hypnotics - Short-term
timeFrame: Week 7
measure: Cumulative Weekly Use of Sedatives/Hypnotics - Long-term
timeFrame: Week 25
measure: Objective Measure of Sleep - Short-term
timeFrame: Week 7
measure: Objective Measure of Sleep - Long-term
timeFrame: Week 25
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Northwest Kidney Centers
state: Washington
Study officials:
affiliation: University of Washington
name: Raj Mehrotra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Unruh M, Cukor D, Rue T, Abad K, Roumelioti ME, McCurry SM, Heagerty P, Mehrotra R. Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis. BMC Nephrol. 2020 Oct 20;21(1):443. doi: 10.1186/s12882-020-02107-x.