Study on Hemodialysis: Illumination Effects (SHINE)

M

Meander Medical Center

Status and phase

Completed
Phase 3

Conditions

Sleep Problems

Treatments

Procedure: light therapy with the device: EnergyLight

Study type

Interventional

Funder types

Other

Identifiers

NCT01064544
R-09.37 M / SHINE

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

14 participants in 2 patient groups

Starting with light therapy
Experimental group
Description:
Starts with 3 weeks of light therapy, followed by a control period
Treatment:
Procedure: light therapy with the device: EnergyLight
Ending with light therapy
Experimental group
Description:
Ends with 3 weeks of light therapy after a control period.
Treatment:
Procedure: light therapy with the device: EnergyLight

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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