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Completed

NCT Number: NCT03534284

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

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).

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Key information

Conditions

Insomnia Chronic Disease Disease Attributes Dyssomnias End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Northwest Kidney Centers

Seattle, Washington, 98122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CBT-I

Trazodone

Drug

trazodone tablet

Other names: Desyrel

Placebo

Drug

Inactive pill manufactured to mimic trazodone tablets.

Other names: Placebo (for trazodone)

Primary outcomes

  1. 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

  2. Insomnia Severity Index (ISI) Long-term

    Time frame: Week 25

    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

Secondary outcomes

  1. Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term

    Time frame: Week 7

    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

  2. Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term

    Time frame: Week 25

    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

  3. Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term

    Time frame: Week 7

    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

  4. Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term

    Time frame: Week 25

    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

  5. Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term

    Time frame: Week 7

    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

  6. Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term

    Time frame: Week 25

    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

  7. Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term

    Time frame: Week 7

    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

  8. Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term

    Time frame: Week 25

    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

  9. Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term

    Time frame: Week 7

    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

  10. Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term

    Time frame: Week 25

    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

  11. Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term

    Time frame: Week 7

    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

  12. Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term

    Time frame: Week 25

    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

  13. 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

  14. 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

  15. Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term

    Time frame: Week 7

    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

  16. Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term

    Time frame: Week 25

    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

  17. Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term

    Time frame: Week 7

    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

  18. 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

  19. Cumulative Weekly Use of Sedatives/Hypnotics - Short-term

    Time frame: Week 7

    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

  20. Cumulative Weekly Use of Sedatives/Hypnotics - Long-term

    Time frame: Week 25

    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

  21. Objective Measure of Sleep - Short-term

    Time frame: Week 7

    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

  22. Objective Measure of Sleep - Long-term

    Time frame: Week 25

    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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Sleep-HD

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 23, 2018
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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