- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03534284
Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (Sleep-HD)
Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (Sleep-HD)
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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98122
- Northwest Kidney Centers
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CBT-I
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
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Once weekly treatment sessions for 6 weeks.
The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules.
The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
Other Names:
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Active Comparator: Medication- Trazodone
Trazodone (50-100 mg):
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trazodone tablet
Other Names:
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Placebo Comparator: Medication- Placebo
Placebo (for trazodone)
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Inactive pill manufactured to mimic trazodone tablets.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Severity Index (ISI) Short-term
Time Frame: 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
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Week 7
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Insomnia Severity Index (ISI) Long-term
Time Frame: Week 25
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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
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Week 25
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term
Time Frame: Week 7
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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
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Week 7
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Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term
Time Frame: Week 25
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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
|
Week 25
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Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term
Time Frame: Week 7
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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
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Week 7
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Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term
Time Frame: Week 25
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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
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Week 25
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Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term
Time Frame: Week 7
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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
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Week 7
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Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term
Time Frame: Week 25
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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
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Week 25
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Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term
Time Frame: Week 7
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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
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Week 7
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Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term
Time Frame: Week 25
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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
|
Week 25
|
Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term
Time Frame: 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
|
Week 7
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Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term
Time Frame: 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
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Week 25
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Objective Measure of Sleep - Long-term
Time Frame: Week 25
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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
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Week 25
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Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term
Time Frame: Week 7
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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
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Week 7
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Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term
Time Frame: Week 25
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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
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Week 25
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Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term
Time Frame: Week 7
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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
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Week 7
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Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term
Time Frame: Week 25
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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
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Week 25
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Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term
Time Frame: Week 7
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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
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Week 7
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Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term
Time Frame: Week 25
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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
|
Week 25
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Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term
Time Frame: Week 7
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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
|
Week 7
|
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term
Time Frame: 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
|
Week 25
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Cumulative Weekly Use of Sedatives/Hypnotics - Short-term
Time Frame: Week 7
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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
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Week 7
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Cumulative Weekly Use of Sedatives/Hypnotics - Long-term
Time Frame: Week 25
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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
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Week 25
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Objective Measure of Sleep - Short-term
Time Frame: Week 7
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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
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Week 7
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Raj Mehrotra, MD, University of Washington
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Kidney Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Sleep Initiation and Maintenance Disorders
- Kidney Failure, Chronic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Tranquilizing Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Anti-Anxiety Agents
- Antidepressive Agents, Second-Generation
- Selective Serotonin Reuptake Inhibitors
- Trazodone
Other Study ID Numbers
- STUDY00004678 (Other Identifier: Emory University Hospital/Winship Cancer Institute)
- R01DK115468 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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