Double blind placebo controlled study on the efficacy of melatonin on sleep parameters and quality of life in hemodialysis patients - Melody

• Conditions: Sleep problems in hemodialysis patients; MedDRA version: 8.1Level: HLGTClassification code 10040991Term: Sleep disorders and disturbances

• Registration Number: EUCTR2006-005719-89-NL
• Lead Sponsor: Meander Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified