Does melatonin by improving sleep parameters improve quality of life of hemodialysis patients?
ID
Source
Brief title
Condition
- Heart failures
- Sleep disturbances (incl subtypes)
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
1) Change in biochemical parameters
2) Change in ProBNP
3) Change in nutritonal status
4) Change in use of medication
5) Change in preload
Background 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
secundary morbidity) of dialysis patients.
Study objective
Does melatonin by improving sleep parameters improve quality of life of
hemodialysis patients?
Study design
Placebo-controlled, double-blind, randomized trial
Intervention
melatonin 3 mg once daily (or placebo)
Study burden and risks
Benefit: Better sleep, better quality of life and possible decreased comorbidity
Burden: wearing actometer (watch), chewing swabs (melatonin in saliva)
Answering questionnaires, 24 hour blood pressure measurement, extra blood
withdrawal
Postbus 1502
3800 BM Amersfoort
Nederland
Postbus 1502
3800 BM Amersfoort
Nederland
Listed location countries
Age
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
6)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | aanmelding clinicaltrials.gov |
| EudraCT | EUCTR2006-005719-89-NL |
| CCMO | NL12440.100.06 |