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

NCT ID: NCT03534284

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-19
• Study Completion Date: 2022-11-17

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.

Conditions

Insomnia; End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CBT-I

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

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

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.

Medication- Trazodone

Trazodone (50-100 mg):

Group Type: ACTIVE_COMPARATOR

Trazodone

Intervention Type: DRUG

trazodone tablet

Medication- Placebo

Placebo (for trazodone)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inactive pill manufactured to mimic trazodone tablets.

Interventions

Cognitive Behavioral Therapy for Insomnia

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.

Intervention Type: BEHAVIORAL

Trazodone

trazodone tablet

Intervention Type: DRUG

Placebo

Inactive pill manufactured to mimic trazodone tablets.

Intervention Type: DRUG

Other Intervention Names

CBT-I; Desyrel; 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Rajnish Mehrotra

Section Head Nephrology, School of Medicine: Department of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raj Mehrotra, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Northwest Kidney Centers

Seattle, Washington, United States

Countries

United States

References

Mehrotra R, Cukor D, McCurry SM, Rue T, Roumelioti ME, Heagerty PJ, Unruh M. Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis : A Randomized Clinical Trial. Ann Intern Med. 2024 Feb;177(2):177-188. doi: 10.7326/M23-1794. Epub 2024 Jan 16.

Reference Type: DERIVED

PMID: 38224591 (View on PubMed)

Unruh M, Cukor D, Rue T, Abad K, Roumelioti ME, McCurry SM, Heagerty P, Mehrotra R. Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis. BMC Nephrol. 2020 Oct 20;21(1):443. doi: 10.1186/s12882-020-02107-x.

Reference Type: DERIVED

PMID: 33081705 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DK115468

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00004678

Identifier Type: -

Identifier Source: org_study_id