Phase 3
N=126
Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
Insomnia · End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT03534284 ↗Enrolled (actual)
126
Serious AEs
32.5%
Results posted
Feb 2024
Primary outcome: Primary: Insomnia Severity Index (ISI) Short-term — 12.47; 11.97; 13.05 score on a scale — p=0.6761
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cognitive Behavioral Therapy for Insomnia (Behavioral); Trazodone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index (ISI) Short-term |
12.47; 11.97; 13.05 | 0.6761 |
| PRIMARY Insomnia Severity Index (ISI) Long-term |
11.34; 12.2; 11.85 | 0.8375 |
| SECONDARY Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term |
9.44; 11.09; 12.39 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term |
9.15; 10.49; 9.95 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term |
7.67; 8.46; 7.5 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term |
7.27; 8.12; 7.94 | — |
| SECONDARY Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term |
32.55; 28.76; 28.5 | — |
| SECONDARY Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term |
32.65; 28.53; 30.7 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term |
4.50; 4.53; 4.21 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term |
4.14; 4.32; 4.80 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term |
4.18; 4.07; 3.61 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term |
3.88; 3.71; 4.30 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term |
6.98; 7.93; 8.27 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term |
6.61; 8.04; 7.34 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term |
5.18; 6.18; 7.04 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term |
5.27; 6.35; 6.29 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term |
31.87; 32.37; 32.80 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term |
33.21; 32.07; 31.85 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term |
49.53; 47.77; 48.29 | — |
| SECONDARY Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term |
50.44; 49.23; 51.38 | — |
| SECONDARY Cumulative Weekly Use of Sedatives/Hypnotics - Short-term |
1.65; 1.29; 1.01 | — |
| SECONDARY Cumulative Weekly Use of Sedatives/Hypnotics - Long-term |
1.58; 2.62; 2.42 | — |
| SECONDARY Objective Measure of Sleep - Short-term |
68.03; 70.94; 70.87 | — |
| SECONDARY Objective Measure of Sleep - Long-term |
68.99; 71.6; 71.57 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03534284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.