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Study on Hemodialysis: Illumination Effects (SHINE)

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ClinicalTrials.gov Identifier: NCT01064544
Recruitment Status : Completed
First Posted : February 8, 2010
Last Update Posted : July 20, 2011
Sponsor:
Information provided by:
Meander Medical Center

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
Sleep Problems Procedure: light therapy with the device: EnergyLight Phase 3

Study Type : Interventional  (Clinical Trial)
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 : March 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Melatonin

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 Name: 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 Name: Philips Energylight




Primary Outcome Measures :
  1. Improvement of sleep parameters [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Change in subjective sleep parameters [ Time Frame: 3 weeks ]
  2. Change in mood [ Time Frame: 3 weeks ]
  3. change in melatonin concentrations [ Time Frame: 3 weeks ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064544


Locations
Netherlands
Meander Medical Center
Amersfoort, Netherlands
Sponsors and Collaborators
Meander Medical Center
Investigators
Study Chair: Carlo Gaillard, MD, PhD Meander Medical Center

Responsible Party: Department of Clinical Pharmacy, Meande Medical Center
ClinicalTrials.gov Identifier: NCT01064544     History of Changes
Other Study ID Numbers: R-09.37 M / SHINE
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Meander Medical Center:
Sleep problems
melatonin
mood
Hemodialysis

Additional relevant MeSH terms:
Dyssomnias
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants