The effect of light and/or melatonin on sleep, mood, cognition and behavior in demented elderly

Completed

• Conditions: Dementia, dementia symptoms; Mental and Behavioural Disorders; Dementia

• Registration Number: ISRCTN93133646
• Lead Sponsor: etherlands Institute for Brain Research (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

Demented elderly, living in the assisted care facilities of 12 different homes for the elderly in different places in the Netherlands.

Exclusion Criteria

Does not comply with the above inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Before starting the supplementation of light and melatonin all subjects were tested for their rest-activity rhythm by actometry, 24-hour salivary melatonin and cortisol levels were measured as was the 24-hour ear temperature. Neuropsychological assessment was done to test cognitive abilities and dementia severity and caregivers were asked about mood, behaviour, sleep and abilities in activities of daily living of the subjects. <br><br>All these measures are again tested six weeks after the start of the change in light and the supplementation of melatonin, to test the relatively short-term effects on changes in rest-activity, rhythmicity of endogenous melatonin, cortisol and temperature rhythm and alterations in mood and behaviour. The long-term effects are tested every six months after the start of light and melatonin as long as a subject participates in the study with a maximum of 3.5 years.

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures