NL-OMON30731已完成3 期
Double blind placebo controlled study on the efficacy of melatonin on sleep parameters and quality of life in hemodialysis patients - Melody
Meander Medisch Centrum0 个研究点目标入组 68 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Informed Consent
- •2) Man/Women between 18 and 85 years
- •3) Understanding and knowledge of the dutch language
- •4) End Stage Renal Disease, stable chronic hemodialysis > 3 months
- •5) SpKt/V(total) > 1,2 pro dialysis
- •6) Validated actometer shows that sleep efficiency < 90% or sleep latency > 15 minutes or fragmentation index > 25 points
排除标准
- •1) 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.
- •2) Instable angina pectoris, heart failure NYHA class IV
- •3) Pregnancy
- •4) Current use of melatonin of known allergy of melatonin
- •5) Participation in other medication/drug research within a month before inclusion
研究者
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