Study on Hemodialysis: Illumination Effects

Phase 3

Completed

• Conditions: Sleep Problems

• Registration Number: NCT01064544
• Lead Sponsor: Meander Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Study Start: 2010-03
• Primary Completion: 2010-04
• Study Completion: 2010-09
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Improvement of sleep parameters	3 weeks

Secondary Outcome Measures

Name	Time	Method
Change in subjective sleep parameters	3 weeks
Change in mood	3 weeks
change in melatonin concentrations	3 weeks

Trial Locations

Locations (1)

Meander Medical Center; 🇳🇱 Amersfoort, Netherlands