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Study on Hemodialysis: Illumination Effects (SHINE)

Primary Purpose

Sleep Problems

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
light therapy with the device: EnergyLight
Sponsored by
Meander Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Problems focused on measuring Sleep problems, melatonin, mood, Hemodialysis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meander Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Starting with light therapy

Ending with light therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement of sleep parameters

Secondary Outcome Measures

Change in subjective sleep parameters
Change in mood
change in melatonin concentrations

Full Information

First Posted
February 3, 2010
Last Updated
July 19, 2011
Sponsor
Meander Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01064544
Brief Title
Study on Hemodialysis: Illumination Effects
Acronym
SHINE
Official Title
Effects of Light Therapy on Sleep, Melatonin Rhythm and Mood in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Meander Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Problems
Keywords
Sleep problems, melatonin, mood, Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Starting with light therapy
Arm Type
Experimental
Arm Description
Starts with 3 weeks of light therapy, followed by a control period
Arm Title
Ending with light therapy
Arm Type
Experimental
Arm Description
Ends with 3 weeks of light therapy after a control period.
Intervention Type
Procedure
Intervention Name(s)
light therapy with the device: EnergyLight
Other Intervention Name(s)
Philips Energylight
Intervention Description
2 hr of light therapy during each hemodialysis session
Primary Outcome Measure Information:
Title
Improvement of sleep parameters
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Change in subjective sleep parameters
Time Frame
3 weeks
Title
Change in mood
Time Frame
3 weeks
Title
change in melatonin concentrations
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Gaillard, MD, PhD
Organizational Affiliation
Meander Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Meander Medical Center
City
Amersfoort
Country
Netherlands

12. IPD Sharing Statement

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Study on Hemodialysis: Illumination Effects

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