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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: | NCT00388661 |
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 improve quality of life of hemodialysis patients with a placebo-controlled study with melatonin to investigate if exogenous melatonin can improve sleep problems and on the longer term improve quality of life (and secondary morbidity) of dialysis patients.
Condition | Intervention | Phase |
---|---|---|
Sleep Problems Hemodialysis |
Drug: Melatonin tablet 3 mg once daily |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Double Blind Placebo-Controlled Study on the Efficacy of Melatonin on Sleep, Resulting in an Improved Quality of Life in Hemodialysis Patients |
Estimated Enrollment: | 68 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Melatonin: Active Comparator
melatonin 3mg
|
Drug: Melatonin tablet 3 mg once daily
Melatonin tablet 3 mg once daily
|
Objective of the study:
Does melatonin by improving sleep parameters improve quality of life of hemodialysis patients?
Study design:
Placebo-controlled, double-blind, randomized trial
Study population:
hemodialysis patients
Intervention:
melatonin 3 mg once daily (or placebo)
Primary study parameters/outcome of the study:
Secondary study parameters/outcome of the study:
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Birgit Koch, PharmD | + 31 850 4608 | BCP.Koch@meandermc.nl |
Netherlands | |
Meander Medical Center | Recruiting |
Amersfoort, Netherlands, 3800 BM | |
Contact: Chris Hagen, MD, PhD + 31 33 8505050 EC.Hagen@meandermc.nl | |
Sub-Investigator: Chris Hagen, PhD, MD | |
Kennemer Gasthuis | Recruiting |
Haarlem, Netherlands, 2035 RC | |
Contact: Wim van Dorp, MD, PhD + 31 23 545 3545 vdorp@kg.nl | |
Principal Investigator: Wim van Dorp, MD, PhD | |
Ziekenhuis Hilversum | Not yet recruiting |
Hilversum, Netherlands, 1213 XZ | |
Contact: Ad van Es, MD, PhD + 31 35 688 7777 avanes@ziekenhuishilversum.nl | |
Principal Investigator: Ad van Es, MD, PhD |
Study Chair: | Pieter ter Wee, MD, PhD | VU University Medical Center |
Responsible Party: | Meander Medical Center ( Department of Clinical Pharmacy ) |
Study ID Numbers: | R-06.31 M / Melody, R-06.31 M |
Study First Received: | October 16, 2006 |
Last Updated: | January 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00388661 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
sleep problems quality of life melatonin sleep apnea |
medication preload nutritional status ProBNP |
Signs and Symptoms Sleep Apnea Syndromes Mental Disorders Apnea Quality of Life |
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 |