Hemodialysis Clinical Trial
Official title:
The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients
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 research the endogenous melatonin rhythm and to improve sleep problems of
hemodialysis patients with a placebo-controlled study with exogenous melatonin. Next to this
a substudy is performed, in which the effect of the change of daytime to nocturnal in
hospital hemodialysis on sleep and melatonin is researched.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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