Study 12 of 645 for search of: "Dyssomnias"
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Melatonin and Quality of Life in Dialysis Patients
This study is currently recruiting participants.
Verified by Meander Medical Center, January 2008
Sponsors and Collaborators: Meander Medical Center
Dutch Kidney Foundation
Information provided by: Meander Medical Center
ClinicalTrials.gov Identifier: NCT00388661
  Purpose

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

MedlinePlus related topics: Dialysis Kidney Failure Sleep Disorders
Drug Information available for: Melatonin
U.S. FDA Resources
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

Further study details as provided by Meander Medical Center:

Primary Outcome Measures:
  • Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36) [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
  • Improvement general health by 15 points (dimension quality of life, RAND SF 36) [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in biochemical parameters [ Time Frame: 3-6-9-12 months ] [ Designated as safety issue: No ]
  • Change in ProBNP [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in nutritional status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in use of medication [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
  • Change in preload [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Detailed Description:

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:

  1. improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)
  2. improvement general health by 15 points (dimension quality of life, RAND SF 36)

Secondary study parameters/outcome of the study:

  1. Change in biochemical parameters
  2. Change in ProBNP
  3. Change in nutritional status
  4. Change in use of medication
  5. Change in preload
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed Consent
  • Man/Women between 18 and 85 years
  • Understanding and knowledge of the dutch language
  • End Stage Renal Disease, stable chronic hemodialysis > 3 months
  • SpKt/V(total) > 1,2 pro dialysis
  • Validated actometer shows that sleep efficiency < 90% or sleep latency > 15 minutes or fragmentation index > 25 points

Exclusion Criteria:

  • Known major illness, which interferes with patient's participation in the study according to the investigator)or which results in a probable patient's survival of less than 1 year.
  • Instable angina pectoris, heart failure NYHA class IV
  • Pregnancy
  • Current use of melatonin of known allergy of melatonin
  • Participation in other medication/drug research within a month before inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388661

Contacts
Contact: Birgit Koch, PharmD + 31 850 4608 BCP.Koch@meandermc.nl

Locations
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            
Sponsors and Collaborators
Meander Medical Center
Dutch Kidney Foundation
Investigators
Study Chair: Pieter ter Wee, MD, PhD VU University Medical Center
  More Information

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)

Keywords provided by Meander Medical Center:
sleep problems
quality of life
melatonin
sleep apnea
medication
preload
nutritional status
ProBNP

Study placed in the following topic categories:
Signs and Symptoms
Sleep Apnea Syndromes
Mental Disorders
Apnea
Quality of Life
Neurologic Manifestations
Dyssomnias
Sleep Disorders
Melatonin

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009