Phase 3
Completed N=126
Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
Source: ClinicalTrials.gov NCT03534284 ↗Enrolled (actual)
126
Serious AEs
32.5%
Results posted
Feb 2024
Primary outcomePrimary: Insomnia Severity Index (ISI) Short-term — 12.47; 11.97; 13.05 score on a scale — p=0.6761
◆ Published Evidence
Established
▲ Trending
22citations · ~11 / year
Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis : A Randomized Clinical Trial.
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).
Linked Publications (2)
-
Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis : A Randomized Clinical Trial.
-
Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.