NL-OMON30731
Completed
Phase 3
Double blind placebo controlled study on the efficacy of melatonin on sleep parameters and quality of life in hemodialysis patients - Melody
Meander Medisch Centrum0 sites68 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Dialysis
- Sponsor
- Meander Medisch Centrum
- Enrollment
- 68
- Status
- Completed
- Last Updated
- last year
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
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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