EUCTR2006-005719-89-NL进行中（未招募）不适用
Double blind placebo controlled study on the efficacy of melatonin on sleep parameters and quality of life in hemodialysis patients - Melody
Meander Medical Center0 个研究点开始时间: 2006年11月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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
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