NCT00388661

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2007

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

2.5 years

First QC Date

October 16, 2006

Last Update Submit

July 19, 2011

Conditions

Sleep ProblemsHaemodialysis

Keywords

sleep problemsquality of lifemelatoninsleep apneamedicationpreloadnutritional statusProBNP

Outcome Measures

Primary Outcomes (2)

  • Improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)

    6-12 months

  • Improvement general health by 15 points (dimension quality of life, RAND SF 36)

    6-12 months

Secondary Outcomes (5)

  • Change in biochemical parameters

    3-6-9-12 months

  • Change in ProBNP

    12 months

  • Change in nutritional status

    12 months

  • Change in use of medication

    6-12 months

  • Change in preload

    12 months

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

melatonin 3mg

Drug: Melatonin tablet 3 mg once daily

Placebo

PLACEBO COMPARATOR
Drug: Placebo comparator

Interventions

Melatonin tablet 3 mg once dailyDRUG

Melatonin tablet 3 mg once daily

Melatonin
Placebo comparatorDRUG

Placebo comparator

Placebo

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Meander Medical Center

Amersfoort, 3800 BM, Netherlands

Location

Kennemer Gasthuis

Haarlem, 2035 RC, Netherlands

Location

MeSH Terms

Conditions

ParasomniasSleep Apnea Syndromes

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomnias

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Pieter ter Wee, MD, PhD

    Amsterdam UMC, location VUmc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 16, 2006

First Posted

October 17, 2006

Study Start

April 1, 2007

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

NL(2)