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

Primary Purpose

Hemodialysis, Peritoneal Dialysis, Sleep Problems

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Melatonin
Sponsored by
Meander Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meander Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 27, 2006
Last Updated
January 28, 2008
Sponsor
Meander Medical Center
Collaborators
Dutch Kidney Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00404456
Brief Title
The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients
Official Title
The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Meander Medical Center
Collaborators
Dutch Kidney Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis, Peritoneal Dialysis, Sleep Problems

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
Melatonin 3 mg once-daily
Primary Outcome Measure Information:
Title
Sleep onset latency < 15 minutes
Title
sleep efficiency > 85%
Title
Normalized melatonin rhythm. Dim Light Melatonin Onset (DLMO) 21:00-23:00 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piet ter Wee, MD, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Study Chair
Facility Information:
Facility Name
Meander Medical Center
City
Amersfoort
ZIP/Postal Code
3818 ES
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19076157
Citation
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. doi: 10.1111/j.1365-2125.2008.03320.x. Epub 2008 Nov 17.
Results Reference
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The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients

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