Haemodialysis, Sleep Problems
Conditions
Keywords
sleep problems, quality of life, melatonin, sleep apnea, medication, preload, nutritional status, ProBNP
Brief summary
Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For a good regulation of these circadian rhythms a uniform external synchronisation is necessary. This is the synchronisation of the biological clock of our body by light and other influences. In case of a disturbance of the external synchronisation, due to for example naps during the day or wake periods at night, internal rhythms can be unlinked. As a result a weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis patients have sleep problems. Their sleep latency is prolonged. They often take a nap during the day and their sleep efficiency is poor. There has only been one study on the melatonin rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this study no link was made between melatonin rhythm and the nature and severity of possible sleep problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm, exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal biological clock and a better quality of life. The aim is to improve quality of life of hemodialysis patients with a placebo-controlled study with melatonin to investigate if exogenous melatonin can improve sleep problems and on the longer term improve quality of life (and secondary morbidity) of dialysis patients.
Detailed description
Objective of the study: Does melatonin by improving sleep parameters improve quality of life of hemodialysis patients? Study design: Placebo-controlled, double-blind, randomized trial Study population: hemodialysis patients Intervention: melatonin 3 mg once daily (or placebo) Primary study parameters/outcome of the study: 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) Secondary study parameters/outcome of the study: 1. Change in biochemical parameters 2. Change in ProBNP 3. Change in nutritional status 4. Change in use of medication 5. Change in preload
Interventions
Melatonin tablet 3 mg once daily
DRUGPlacebo comparator
Placebo comparator
Sponsors
Dutch Kidney Foundation
Meander Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Informed Consent * Man/Women between 18 and 85 years * Understanding and knowledge of the dutch language * End Stage Renal Disease, stable chronic hemodialysis \> 3 months * SpKt/V(total) \> 1,2 pro dialysis * Validated actometer shows that sleep efficiency \< 90% or sleep latency \> 15 minutes or fragmentation index \> 25 points
Exclusion criteria
* 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. * Instable angina pectoris, heart failure NYHA class IV * Pregnancy * Current use of melatonin of known allergy of melatonin * Participation in other medication/drug research within a month before inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36) | 6-12 months |
| Improvement general health by 15 points (dimension quality of life, RAND SF 36) | 6-12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in biochemical parameters | 3-6-9-12 months |
| Change in use of medication | 6-12 months |
| Change in nutritional status | 12 months |
| Change in ProBNP | 12 months |
| Change in preload | 12 months |
Countries
Netherlands
Outcome results
None listed