A Randomized, Prospective, Double Blind, Placebo-Controlled Trial of Two Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders
试验速览
- 阶段
- 2 期
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Primary Objective
研究概览
简要总结
The study will evaluate the safety and efficacy of melatonin supplementation in CKD and ESRD patients with sleep disorders to reduce sleep latency times, the number of apnea/hypopneic episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients with sleep disordered breathing.
详细描述
The study will look at the safety and efficacy of melatonin supplementation given to patients with chronic kidney disease and end stage renal disease who have sleep disorders to reduce sleep latency times, the number of apnea/hypopneic episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients with sleep disordered breathing.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient age > 18 and <85 years of age
- •Patients with CKD or ESRD with eGFR < 30 mls/min
- •If receiving hemodialysis, patients must be on treatment > 3 months
- •Normal healthy controls must be without a known history of CKD and be willing to have formal PSG test and plasma melatonin measurements
排除标准
- •Patients receiving outpatient hemodialysis for < 3 months
- •Patients with estimated GFR by Cockcroft Gault > 30 mls/min
- •Patients receiving beta blocker therapy within one month of randomization
- •Patients receiving Nifedipine therapy within one month randomization
- •Patients on peritoneal dialysis
- •Patient with chronic home oxygen supplementation
- •Patients receiving chronic home CPAP therapy
- •Patients actively receiving outpatient sleep medications
- •Patients with diabetic gastroparesis unresponsive to medication
- •Patients with known pregnancy or unwilling to use contraception during the course of the study
- •Patients with a functioning renal allograft
- •Patient currently receiving long-term immunosuppressive therapy. Patients receiving low dose prednisone (10mg or less per day) will not be excluded from this trial
- •Unable to give informed consent
研究组 & 干预措施
Placebo controlled
comparison of placebo controlled to 1mg melatonin or 3mg melatonin
干预措施: Melatonin (Drug)
Melatonin
comparison of melatonin 1mg or melatonin 3mg
干预措施: Melatonin (Drug)
结局指标
主要结局
Primary Objective
时间窗: Compare sleep duration at the end of 60 days
Patients taking melatonin supplement, 1mg or 3mg daily, compared to placebo controlled group will be compared to see who group achieved a 25% reduction in sleep latency or 25% increase in total sleep time at the end of 60 days. Using the Pittsburg Sleep Quality Index (PSQI) questionnaire as the index to measure quality of sleep and sleep patterns. Study will also use Polysomnography testing that will record duration of sleep patterns.
次要结局
未报告次要终点