Double Blind Placebo-controlled Study on the Efficacy of Melatonin on Sleep, Resulting in an Improved Quality of Life in Hemodialysis Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)
研究概览
简要总结
Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For a good regulation of these circadian rhythms a uniform external synchronisation is necessary. This is the synchronisation of the biological clock of our body by light and other influences. In case of a disturbance of the external synchronisation, due to for example naps during the day or wake periods at night, internal rhythms can be unlinked. As a result a weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis patients have sleep problems. Their sleep latency is prolonged. They often take a nap during the day and their sleep efficiency is poor. There has only been one study on the melatonin rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this study no link was made between melatonin rhythm and the nature and severity of possible sleep problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm, exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal biological clock and a better quality of life.
The aim is to improve quality of life of hemodialysis patients with a placebo-controlled study with melatonin to investigate if exogenous melatonin can improve sleep problems and on the longer term improve quality of life (and secondary morbidity) of dialysis patients.
详细描述
Objective of the study:
Does melatonin by improving sleep parameters improve quality of life of hemodialysis patients?
Study design:
Placebo-controlled, double-blind, randomized trial
Study population:
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
- 否
入选标准
- •Informed Consent
- •Man/Women between 18 and 85 years
- •Understanding and knowledge of the dutch language
- •End Stage Renal Disease, stable chronic hemodialysis > 3 months
- •SpKt/V(total) > 1,2 pro dialysis
- •Validated actometer shows that sleep efficiency < 90% or sleep latency > 15 minutes or fragmentation index > 25 points
排除标准
- •Known major illness, which interferes with patient's participation in the study according to the investigator)or which results in a probable patient's survival of less than 1 year.
- •Instable angina pectoris, heart failure NYHA class IV
- •Pregnancy
- •Current use of melatonin of known allergy of melatonin
- •Participation in other medication/drug research within a month before inclusion
研究组 & 干预措施
Melatonin
melatonin 3mg
干预措施: Melatonin tablet 3 mg once daily (Drug)
Placebo
干预措施: Placebo comparator (Drug)
结局指标
主要结局
Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)
时间窗: 6-12 months
Improvement general health by 15 points (dimension quality of life, RAND SF 36)
时间窗: 6-12 months
次要结局
- Change in biochemical parameters(3-6-9-12 months)
- Change in ProBNP(12 months)
- Change in nutritional status(12 months)
- Change in use of medication(6-12 months)
- Change in preload(12 months)