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OpenTrials
Completed

NCT Number: NCT01064544

Study on Hemodialysis: Illumination Effects

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.

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Key information

Conditions

Sleep Problems Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Meander Medical Center

Amersfoort, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

light therapy with the device: EnergyLight

Procedure

2 hr of light therapy during each hemodialysis session

Other names: Philips Energylight

Primary outcomes

  1. Improvement of sleep parameters

    Time frame: 3 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Meander Medical Center

Other

Registry information

Official study title

Effects of Light Therapy on Sleep, Melatonin Rhythm and Mood in Hemodialysis Patients

Acronym: SHINE

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 8, 2010
Registry last updated
Jul 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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