Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (Sleep-HD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI) Short-term
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CBT-I
Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
Medication- Trazodone
Trazodone (50-100 mg):
干预措施: Trazodone (Drug)
Medication- Placebo
Placebo (for trazodone)
干预措施: Placebo (Drug)
结局指标
主要结局
Insomnia Severity Index (ISI) Short-term
时间窗: 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
时间窗: 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
次要结局
- 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- Long-term(Week 25)
- Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term(Week 7)
- Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term(Week 7)
- Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term(Week 25)
- Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term(Week 7)
- Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term(Week 7)
- Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term(Week 25)
- Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term(Week 25)
- 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) - Generalized Anxiety Disorder 7 Scale - Long-term(Week 25)
- Cumulative Weekly Use of Sedatives/Hypnotics - Short-term(Week 7)
- Objective Measure of Sleep - Short-term(Week 7)
- Objective Measure of Sleep - Long-term(Week 25)
- Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term(Week 7)
- Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term(Week 25)
- Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term(Week 7)
- Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term(Week 25)
- Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term(Week 7)
- Cumulative Weekly Use of Sedatives/Hypnotics - Long-term(Week 25)
研究者
Rajnish Mehrotra
Section Head Nephrology, School of Medicine: Department of Medicine
University of Washington