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

Primary Purpose

Insomnia, End Stage Renal Disease

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy for Insomnia

Trazodone

Placebo

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Hemodialysis, Kidney disease, Trazodone, Cognitive behavioral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northwest Kidney Centers

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CBT-I

Medication- Trazodone

Medication- Placebo

Arm Description

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

Trazodone (50-100 mg):

Placebo (for trazodone)

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Full Information

NCT ID

NCT03534284

First Posted

May 1, 2018

Last Updated

May 25, 2023

Sponsor

University of Washington

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03534284

Brief Title

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

Acronym

Sleep-HD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

September 19, 2018 (Actual)

Primary Completion Date

October 17, 2022 (Actual)

Study Completion Date

November 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia, End Stage Renal Disease

Keywords

Hemodialysis, Kidney disease, Trazodone, Cognitive behavioral therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigator

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.

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT-I

Arm Type

Active Comparator

Arm Description

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

Arm Title

Medication- Trazodone

Arm Type

Active Comparator

Arm Description

Trazodone (50-100 mg):

Arm Title

Medication- Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (for trazodone)

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy for Insomnia

Other Intervention Name(s)

CBT-I

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

Trazodone

Other Intervention Name(s)

Desyrel

Intervention Description

trazodone tablet

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo (for trazodone)

Intervention Description

Inactive pill manufactured to mimic trazodone tablets.

Primary Outcome Measure Information:

Title

Insomnia Severity Index (ISI) Short-term

Description

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

Time Frame

Week 7

Title

Insomnia Severity Index (ISI) Long-term

Description

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

Time Frame

Week 25

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Week 7

Title

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

Description

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

Time Frame

Week 25

Title

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

Description

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

Time Frame

Week 7

Title

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

Description

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

Time Frame

Week 25

Title

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

Description

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

Time Frame

Week 7

Title

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

Description

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

Time Frame

Week 25

Title

Patient-reported Outcomes (PRO) - Two-Item Graded Chronic Pain scale - Short-term

Description

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

Time Frame

Week 7

Title

Patient-reported Outcomes (PRO) - Two-Item Graded Chronic Pain scale - Long-term

Description

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

Time Frame

Week 25

Title

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

Description

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

Time Frame

Week 7

Title

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

Description

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

Time Frame

Week 25

Title

Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term

Description

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

Time Frame

Week 7

Title

Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term

Description

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

Time Frame

Week 25

Title

Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 scale - Short-term

Description

Time Frame

Week 7

Title

Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 scale - Long-term

Description

Time Frame

Week 25

Title

Cumulative Weekly use of Sedatives/Hypnotics - Short-term

Description

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

Time Frame

Week 7

Title

Cumulative Weekly use of Sedatives/Hypnotics - Long-term

Description

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

Time Frame

Week 25

Title

Objective Measure of Sleep - Short-term

Description

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

Time Frame

Week 6

Title

Objective Measure of Sleep - Long-term

Description

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

Time Frame

Week 25

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raj Mehrotra, MD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwest Kidney Centers

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33081705

Citation

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.

Results Reference

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

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