The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

November 27, 2006

Last Updated Date

January 28, 2008

Start Date ^ICMJE

April 2005

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00404456 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients

Official Title ^ICMJE

The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hemodialysis
Peritoneal Dialysis
Sleep Problems

Intervention ^ICMJE

Drug: Melatonin

Study Arms / Comparison Groups

Publications *

Koch BC, Nagtegaal JE, Hagen EC, van der Westerlaken MM, Boringa JB, Kerkhof GA, Ter Wee PM. The effects of melatonin on sleep-wake rhythm of daytime haemodialysis patients: a randomized, placebo-controlled, cross-over study (EMSCAP study). Br J Clin Pharmacol. 2009 Jan;67(1):68-75. Epub 2008 Nov 17.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00404456

Responsible Party

Study ID Numbers ^ICMJE

EMSCAP

Study Sponsor ^ICMJE

Meander Medical Center

Collaborators ^ICMJE

Dutch Kidney Foundation

Investigators ^ICMJE

Study Chair:

Piet ter Wee, MD, PhD

VU University Medical Center

Information Provided By

Meander Medical Center

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP