Study on Hemodialysis: Illumination Effects

Sleep Problems Clinical Trial

— SHINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064544
• Other study ID #: R-09.37 M / SHINE
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2010
• Last updated: July 19, 2011
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: July 2011
• Source: Meander Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disorders
• Sleep Problems

Intervention

Procedure:
• light therapy with the device: EnergyLight
2 hr of light therapy during each hemodialysis session

Locations

Country	Name	City	State
Netherlands	Meander Medical Center	Amersfoort

Sponsors (1)

Lead Sponsor	Collaborator
Meander Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of sleep parameters		3 weeks	No
Secondary	Change in subjective sleep parameters		3 weeks	No
Secondary	Change in mood		3 weeks	No
Secondary	change in melatonin concentrations		3 weeks	No