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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28032
Enrollment
189
Registered
2005-05-23
Start date
1999-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Ceiling mounted indirect bright light (1000 lux in gaze direction) or ceiling mounted placebo light (300 lux in gaze direction), 6 homes in each condition. Furthermore, all participants were randomiz

Sponsors

None listed

Eligibility

Inclusion criteria

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

Exclusion criteria: N/A

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactR.F. Riemersma-van der Lek

Netherlands Institute for Brain Research, Meibergdreef 33

r.riemersma@nih.knaw.nl+31 (0)20 5665488

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)