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Sponsors and Collaborators: |
Meander Medical Center Dutch Kidney Foundation |
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Information provided by: | Meander Medical Center |
ClinicalTrials.gov Identifier: | NCT00404456 |
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 |
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Hemodialysis Peritoneal Dialysis Sleep Problems |
Drug: Melatonin |
Phase III |
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 |
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) |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Meander Medical Center | |
Amersfoort, Netherlands, 3818 ES |
Study Chair: | Piet ter Wee, MD, PhD | VU University Medical Center |
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) |
Signs and Symptoms Mental Disorders Neurologic Manifestations |
Dyssomnias Sleep Disorders Melatonin |
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 |