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The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients
This study has been completed.
Sponsors and Collaborators: Meander Medical Center
Dutch Kidney Foundation
Information provided by: Meander Medical Center
ClinicalTrials.gov Identifier: NCT00404456
  Purpose

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.


Condition Intervention Phase
Hemodialysis
Peritoneal Dialysis
Sleep Problems
Drug: Melatonin
Phase III

MedlinePlus related topics: Dialysis Kidney Failure Sleep Disorders
Drug Information available for: Melatonin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title: The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients

Further study details as provided by Meander Medical Center:

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

Estimated Enrollment: 40
Study Start Date: April 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Melatonin
    Melatonin 3 mg once-daily
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404456

Locations
Netherlands
Meander Medical Center
Amersfoort, Netherlands, 3818 ES
Sponsors and Collaborators
Meander Medical Center
Dutch Kidney Foundation
Investigators
Study Chair: Piet ter Wee, MD, PhD VU University Medical Center
  More Information

Publications indexed to this study:
Study ID Numbers: EMSCAP
Study First Received: November 27, 2006
Last Updated: January 28, 2008
ClinicalTrials.gov Identifier: NCT00404456  
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Study placed in the following topic categories:
Signs and Symptoms
Mental Disorders
Neurologic Manifestations
Dyssomnias
Sleep Disorders
Melatonin

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Depressants
Protective Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009