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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: July 2007

Intervention(s) in this Clinical Trial

• Drug: Melatonin
  • Melatonin 3 mg once-daily

Primary Measures

• Sleep onset latency < 15 minutes
• sleep efficiency > 85%
• Normalized melatonin rhythm. Dim Light Melatonin Onset (DLMO) 21:00-23:00 hour

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Meander Medical Center

Overall Clinical Trial Officials and Contacts

Piet ter Wee, MD, PhD Study Chair VU University Medical Center  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00404456

Study ID Number: EMSCAP

ClinicalTrials.gov Identifier: NCT00404456

Health Authority: Netherlands: Medical Ethics Review Committee (METC)