EUCTR2006-005719-89-NL
Active, not recruiting
Not Applicable
Double blind placebo controlled study on the efficacy of melatonin on sleep parameters and quality of life in hemodialysis patients - Melody
Meander Medical Center0 sitesNovember 10, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Meander Medical Center
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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