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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03534284
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Rajnish Mehrotra, University of Washington

Tracking Information
First Submitted Date  ICMJE May 1, 2018
First Posted Date  ICMJE May 23, 2018
Last Update Posted Date October 18, 2018
Actual Study Start Date  ICMJE September 19, 2018
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Patient-reported Outcomes (PRO) - Two-Item Graded Chronic Pain scale - Short-term [ Time Frame: Week 7 ]
    Score from Two-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
  • Patient-reported Outcomes (PRO) - Two-Item Graded Chronic Pain scale - Long-term [ Time Frame: Week 25 ]
    Score from Two-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
  • 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
  • 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
  • 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
  • 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
  • Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 scale - Short-term [ Time Frame: Week 7 ]
    Score from Quality of Life Short Form 12 scale, 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
  • Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 scale - Long-term [ Time Frame: Week 25 ]
    Score from Quality of Life Short Form 12 scale, 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
  • 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
  • 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
  • Objective Measure of Sleep - Short-term [ Time Frame: Week 6 ]
    Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 6 describing the short-term effect of the intervention
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
Official Title  ICMJE Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (Sleep-HD)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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.
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.
Primary Purpose: Treatment
Condition  ICMJE
  • Insomnia
  • End Stage Renal Disease
Intervention  ICMJE
  • Behavioral: 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.
    Other Name: CBT-I
  • Drug: Trazodone
    trazodone tablet
    Other Name: Desyrel
  • Drug: Placebo
    Inactive pill manufactured to mimic trazodone tablets.
    Other Name: Placebo (for trazodone)
Study Arms  ICMJE
  • Active Comparator: CBT-I
    Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
    Intervention: Behavioral: Cognitive Behavioral Therapy for Insomnia
  • Active Comparator: Medication- Trazodone
    Trazodone (50-100 mg):
    Intervention: Drug: Trazodone
  • Placebo Comparator: Medication- Placebo
    Placebo (for trazodone)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 11, 2018)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lori Linke 206-720-3835 llinke@nephrology.washington.edu
Contact: Carlyn Clark, MSW 206-720-8811 cclark@nephrology.washington.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03534284
Other Study ID Numbers  ICMJE STUDY00004678
R01DK115468 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rajnish Mehrotra, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Raj Mehrotra, MD University of Washington
PRS Account University of Washington
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP