Study on Hemodialysis: Illumination Effects (SHINE)

This study has been completed.
Sponsor:
Information provided by:
Meander Medical Center
ClinicalTrials.gov Identifier:
NCT01064544
First received: February 3, 2010
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Light Therapy on Sleep, Melatonin Rhythm and Mood in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Meander Medical Center:

Primary Outcome Measures:
  • Improvement of sleep parameters [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in subjective sleep parameters [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Change in mood [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • change in melatonin concentrations [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064544

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

No publications provided

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
Study First Received: February 3, 2010
Last Updated: July 19, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on July 31, 2014