The effect of light and/or melatonin on sleep, mood, cognition and behavior in demented elderly.
Completed
- Registration Number
- NL-OMON28032
- Brief Summary
JAMA. 2008 Jun 11;299(22):2642-55.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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
N/A
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Before starting the suppletion 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, behavior, sleep and abilities in activities of daily living of the subjects. All these measures are again tested 6 weeks after the start of the change in light and the suppletion 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 behavior. The long-term effects are tested every 6 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 Before starting the suppletion 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, behavior, sleep and abilities in activities of daily living of the subjects. All these measures are again tested 6 weeks after the start of the change in light and the suppletion 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 behavior. The long-term effects are tested every 6 months after the start of light and melatonin as long as a subject participates in the study with a maximum of 3.5 years.