Official Title

The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients
  • Phase

    Phase 3
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    melatonin ...
  • Study Participants

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.
Study Started
Apr 30
Primary Completion
Jul 31
Study Completion
Jul 31
Last Update
Jan 29

Drug Melatonin

Melatonin 3 mg once-daily


Inclusion Criteria:

Stable Peritoneal dialysis
Stable Hemodialysis
Age 18-85 years

Exclusion Criteria:

use of hypnotics, MAO inhibitors or neuroleptics
Liver disease
Participation in drug investigation < 1 months to start
Former use of melatonin
Severe neurological/psychiatric disease
Allergic to melatonin or additives
No Results Posted