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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404456
• Other study ID #: EMSCAP
• Status: Completed
• Phase: Phase 3
• First received: November 27, 2006
• Last updated: January 28, 2008
• Start date: April 2005
• Est. completion date: July 2007

Study information

• Verified date: January 2008
• Source: Meander Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyssomnias
• Hemodialysis
• Parasomnias
• Peritoneal Dialysis
• Sleep Disorders
• Sleep Problems

Intervention

Drug:
• Melatonin
Melatonin 3 mg once-daily

Locations

Country	Name	City	State
Netherlands	Meander Medical Center	Amersfoort

Sponsors (2)

Lead Sponsor	Collaborator
Meander Medical Center	Dutch Kidney Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep onset latency < 15 minutes
Primary	sleep efficiency > 85%
Primary	Normalized melatonin rhythm. Dim Light Melatonin Onset (DLMO) 21:00-23:00 hour