Study on Hemodialysis: Illumination Effects (SHINE)

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)

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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