跳至主要内容
临床试验/NCT00404456
NCT00404456已完成3 期

The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients

Meander Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年4月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Sleep onset latency < 15 minutes

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 research the endogenous melatonin rhythm and to improve sleep problems of hemodialysis patients with a placebo-controlled study with exogenous melatonin. Next to this a substudy is performed, in which the effect of the change of daytime to nocturnal in hospital hemodialysis on sleep and melatonin is researched.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

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

入选标准

  • Stable Peritoneal dialysis
  • Stable Hemodialysis
  • Age 18-85 years

排除标准

  • use of hypnotics, MAO inhibitors or neuroleptics
  • Liver disease
  • Participation in drug investigation < 1 months to start
  • Former use of melatonin
  • Severe neurological/psychiatric disease
  • Allergic to melatonin or additives

结局指标

主要结局

Sleep onset latency < 15 minutes

sleep efficiency > 85%

Normalized melatonin rhythm. Dim Light Melatonin Onset (DLMO) 21:00-23:00 hour

次要结局

未报告次要终点

研究者

发起方
Meander Medical Center
申办方类型
Other

研究点 (2)

Loading locations...

相似试验

The Efficacy of Melatonin in Sleep Problems of... | 临床试验