Sleep problems in hemodialysis patients MedDRA version: 8.1 Level: HLGT Classification code 10040991 Term: Sleep disorders and disturbances
Conditions
Interventions
Product Name: Bio-Melatonin 3 mg
Product Code: Melatonin 3
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: melatonin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Meander Medical Center
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does melatonin by improving sleep parameters improve quality of life of hemodialysis patients?;Secondary Objective: Change in biochemical parameters Change in ProBNP Change in nutritional status Change in use of medication Change in preload;Primary end point(s): 1) improvement of vitality (dimension quality of life) by 15 points (RAND SF 36) 2) improvement general health by 15 points (dimension quality of life, RAND SF 36) | — |
Countries
Netherlands
Outcome results
None listed