NCT00404456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 29, 2008

Status Verified

January 1, 2008

Enrollment Period

2.2 years

First QC Date

November 27, 2006

Last Update Submit

January 28, 2008

Conditions

HemodialysisPeritoneal DialysisSleep Problems

Outcome Measures

Primary Outcomes (3)

  • Sleep onset latency < 15 minutes

  • sleep efficiency > 85%

  • Normalized melatonin rhythm. Dim Light Melatonin Onset (DLMO) 21:00-23:00 hour

Interventions

MelatoninDRUG

Melatonin 3 mg once-daily

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable Peritoneal dialysis
  • Stable Hemodialysis
  • Age 18-85 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meander Medical Center

Amersfoort, 3818 ES, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 19076157DERIVED

MeSH Terms

Conditions

Parasomnias

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Piet ter Wee, MD, PhD

    Amsterdam UMC, location VUmc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 27, 2006

First Posted

November 28, 2006

Study Start

April 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

January 29, 2008

Record last verified: 2008-01

Locations

NL(1)