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

Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (Sleep-HD)

Sponsors

Lead Sponsor: University of Washington

Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source 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). 125 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.

Overall Status Recruiting
Start Date 2018-09-19
Completion Date 2022-10-01
Primary Completion Date 2022-04-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Insomnia Severity Index (ISI) Short-term Week 7
Insomnia Severity Index (ISI) Long-term Week 25
Secondary Outcome
Measure Time Frame
Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term Week 7
Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term Week 25
Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term Week 7
Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term Week 25
Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term Week 7
Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term Week 25
Patient-reported Outcomes (PRO) - Two-Item Graded Chronic Pain scale - Short-term Week 7
Patient-reported Outcomes (PRO) - Two-Item Graded Chronic Pain scale - Long-term Week 25
Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term Week 7
Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term Week 25
Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term Week 7
Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term Week 25
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 scale - Short-term Week 7
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 scale - Long-term Week 25
Cumulative Weekly use of Sedatives/Hypnotics - Short-term Week 7
Cumulative Weekly use of Sedatives/Hypnotics - Long-term Week 25
Objective Measure of Sleep - Short-term Week 6
Objective Measure of Sleep - Long-term Week 25
Enrollment 125
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Cognitive Behavioral Therapy for Insomnia

Description: 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.

Arm Group Label: CBT-I

Other Name: CBT-I

Intervention Type: Drug

Intervention Name: Trazodone

Description: trazodone tablet

Arm Group Label: Medication- Trazodone

Other Name: Desyrel

Intervention Type: Drug

Intervention Name: Placebo

Description: Inactive pill manufactured to mimic trazodone tablets.

Arm Group Label: Medication- Placebo

Other Name: Placebo (for trazodone)

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Raj Mehrotra, MD Principal Investigator University of Washington
Overall Contact

Last Name: Lori Linke

Phone: 206-720-3835

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Northwest Kidney Centers Lori Linke, BA 206-720-3835 [email protected]
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Washington

Investigator Full Name: Rajnish Mehrotra

Investigator Title: Section Head Nephrology, School of Medicine: Department of Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: CBT-I

Type: Active Comparator

Description: Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.

Label: Medication- Trazodone

Type: Active Comparator

Description: Trazodone (50-100 mg):

Label: Medication- Placebo

Type: Placebo Comparator

Description: Placebo (for trazodone)

Acronym Sleep-HD
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Masking: Triple (Participant, Care Provider, Investigator)

Masking Description: The investigator, the participant, and the care provider will be blinded to the drug assignment (trazodone vs. placebo) for those subjects randomized into the medication intervention arm.

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