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

NCT03534284 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: STUDY00004678R01DK115468
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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).

Conditions

Insomnia; End Stage Renal Disease

Keywords

Hemodialysis; Kidney disease; Trazodone; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (2)

• Insomnia Severity Index (ISI) Short-term

  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

  Week 7

• Insomnia Severity Index (ISI) Long-term

  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

  Week 25

Secondary Outcomes (22)

• 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

Study Arms (3)

CBT-I

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy for Insomnia

Medication- Trazodone

ACTIVE COMPARATOR

Trazodone (50-100 mg):

Drug: Trazodone

Medication- Placebo

PLACEBO COMPARATOR

Placebo (for trazodone)

Drug: Placebo

Interventions

Cognitive Behavioral Therapy for Insomnia 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.

Also known as: CBT-I

CBT-I

Trazodone DRUG

trazodone tablet

Also known as: Desyrel

Medication- Trazodone

Placebo DRUG

Inactive pill manufactured to mimic trazodone tablets.

Also known as: Placebo (for trazodone)

Medication- Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Northwest Kidney Centers

Seattle, Washington, 98122, United States

Location

Related Publications (2)

• 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.

  PMID: 38224591 DERIVED

• 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.

  PMID: 33081705 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Kidney Failure, Chronic; Kidney Diseases

Interventions

Cognitive Behavioral Therapy; Trazodone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Results Point of Contact

• Title: Dr. Raj Mehrotra
• Organization: University of Washington

rmehrotr@uw.edu

206-221-7138

Study Officials

• Raj Mehrotra, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Head Nephrology, School of Medicine: Department of Medicine

Model Details: 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 Record Dates

• First Submitted: May 1, 2018
• First Posted: May 23, 2018
• Study Start: September 19, 2018
• Primary Completion: October 17, 2022
• Study Completion: November 17, 2022
• Last Updated: February 5, 2024
• Results First Posted: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)