- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00404456
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Amersfoort, Netherlands, 3818 ES
- Meander Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Sleep onset latency < 15 minutes
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sleep efficiency > 85%
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Normalized melatonin rhythm. Dim Light Melatonin Onset (DLMO) 21:00-23:00 hour
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Piet ter Wee, MD, PhD, Amsterdam UMC, location VUmc
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMSCAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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