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

Phase 3

Completed

Conditions: Insomnia
End Stage Renal Disease

Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia
Drug: Placebo
Drug: Trazodone

Registration Number: NCT03534284

Lead Sponsor: University of Washington

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 126

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-I	Cognitive Behavioral Therapy for Insomnia	Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Medication- Placebo	Placebo	Placebo (for trazodone)
Medication- Trazodone	Trazodone	Trazodone (50-100 mg):

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI) Short-term	Week 7	summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 7 describing the short-term effect of the intervention
Insomnia Severity Index (ISI) Long-term	Week 25	summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 25 describing the long-term effect of the intervention

Secondary Outcome Measures

Name	Time	Method
Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term	Week 7	Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 7 describing the short-term effect of the intervention
Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term	Week 25	Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 25 describing the long-term effect of the intervention
Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term	Week 7	Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 7 describing the short-term effect of the intervention
Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term	Week 25	Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 25 describing the long-term effect of the intervention
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term	Week 7	Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 7 describing the short-term effect of the intervention
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term	Week 25	Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 25 describing the long-term effect of the intervention
Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term	Week 7	Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 7 describing the short-term effect of the intervention
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term	Week 7	Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term	Week 25	Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term	Week 25	Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention
Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term	Week 7	Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 7 describing the short-term effect of the intervention
Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term	Week 25	Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 25 describing the long-term effect of the intervention
Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term	Week 25	Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 25 describing the long-term effect of the intervention
Cumulative Weekly Use of Sedatives/Hypnotics - Short-term	Week 7	This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 7 describing the short-term effect of the intervention
Objective Measure of Sleep - Short-term	Week 7	Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 7 describing the short-term effect of the intervention
Objective Measure of Sleep - Long-term	Week 25	Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 25 describing the long-term effect of the intervention
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term	Week 7	Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 7 describing the short-term effect of the intervention
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term	Week 25	Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 25 describing the long-term effect of the intervention
Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term	Week 7	Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 7 describing the short-term effect of the intervention
Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term	Week 25	Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 25 describing the long-term effect of the intervention
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term	Week 7	Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention
Cumulative Weekly Use of Sedatives/Hypnotics - Long-term	Week 25	This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 25 describing the long-term effect of the intervention