NCT01064544

Brief Summary

Previous research has shown that sleep quality in hemodialysis patients is disturbed. One of the possible explanations is an insufficient or disturbed melatonin rhythm. Melatonin rhythm is regulated by exposure to light. In this feasibility study, the investigators examine the effects of light therapy during dialysis on sleep, melatonin rhythm and mood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2010

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

1 month

First QC Date

February 3, 2010

Last Update Submit

July 19, 2011

Conditions

Sleep Problems

Keywords

Sleep problemsmelatoninmoodHemodialysis

Outcome Measures

Primary Outcomes (1)

  • Improvement of sleep parameters

    3 weeks

Secondary Outcomes (3)

  • Change in subjective sleep parameters

    3 weeks

  • Change in mood

    3 weeks

  • change in melatonin concentrations

    3 weeks

Study Arms (2)

Starting with light therapy

EXPERIMENTAL

Starts with 3 weeks of light therapy, followed by a control period

Procedure: light therapy with the device: EnergyLight

Ending with light therapy

EXPERIMENTAL

Ends with 3 weeks of light therapy after a control period.

Procedure: light therapy with the device: EnergyLight

Interventions

light therapy with the device: EnergyLightPROCEDURE

2 hr of light therapy during each hemodialysis session

Also known as: Philips Energylight
Ending with light therapyStarting with light therapy

Eligibility Criteria

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

You may qualify if:

  • informed consent
  • men/women aged 18-85 years
  • knowledge of the dutch language
  • hemodialysis patient
  • subjective sleep problems (Epworth sleepiness score \>9)

You may not qualify if:

  • known major illness, which interferes with patient's participation
  • use of melatonin/hypnotics
  • use of photosensitizing medication
  • jet lag or travel \> 1 time zone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meander Medical Center

Amersfoort, Netherlands

Location

MeSH Terms

Conditions

Parasomnias

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Carlo Gaillard, MD, PhD

    Meander Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 8, 2010

Study Start

March 1, 2010

Primary Completion

April 1, 2010

Study Completion

September 1, 2010

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

NL(1)