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SHINE: Study on Hemodialysis: Illumination Effects

Sponsor
Meander Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01064544
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
6
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: light therapy with the device: EnergyLight
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Light Therapy on Sleep, Melatonin Rhythm and Mood in Hemodialysis Patients
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Starting with light therapy

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

Procedure: light therapy with the device: EnergyLight
2 hr of light therapy during each hemodialysis session
Other Names:
  • Philips Energylight

    		•
    Experimental: Ending with light therapy

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

    Procedure: light therapy with the device: EnergyLight
    2 hr of light therapy during each hemodialysis session
    Other Names:
  • Philips Energylight

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement of sleep parameters [3 weeks]

    Secondary Outcome Measures

    1. Change in subjective sleep parameters [3 weeks]

    2. Change in mood [3 weeks]

    3. change in melatonin concentrations [3 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • informed consent

    • men/women aged 18-85 years

    • knowledge of the dutch language

    • hemodialysis patient

    • subjective sleep problems (Epworth sleepiness score >9)

    Exclusion Criteria:

    • known major illness, which interferes with patient's participation

    • use of melatonin/hypnotics

    • use of photosensitizing medication

    • jet lag or travel > 1 time zone

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Meander Medical Center Amersfoort Netherlands

    Sponsors and Collaborators

    • Meander Medical Center

    Investigators

    • Study Chair: Carlo Gaillard, MD, PhD, Meander Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01064544
    Other Study ID Numbers:
    • R-09.37 M / SHINE
    First Posted:
    Feb 8, 2010
    Last Update Posted:
    Jul 20, 2011
    Last Verified:
    Jul 1, 2011
    Keywords provided by , ,
    Sleep problems
    melatonin
    mood
    Hemodialysis
    Additional relevant MeSH terms:
    Dyssomnias
    Parasomnias

    Study Results

    No Results Posted as of Jul 20, 2011