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

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR83
• Date of registration: 23/05/2005
• Primary sponsor: Netherlands Institute for Brain Research
• Public title: The effect of light and/or melatonin on sleep, mood, cognition and behavior in demented elderly.
• Scientific title: The effect of light and/or melatonin on sleep, mood, cognition and behavior in demented elderly. - Light and melatonin in dementia
• Date of first enrolment: 1/6/1999
• Target sample size: 189
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=83
• Study type: intervention
• Study design: Randomised: Yes; Masking: Single; Control: Placebo; Group: Parallel; Type: [default]

Countries of recruitment

The Netherlands

Contacts

• Name: E.J.W. Someren, van

• Name: R.F. Riemersma-van der Lek

Key inclusion & exclusion 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: N/A

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Dementia, Dementia symptoms

Intervention(s)

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 randomized to melatonin (2.5 mg) or placebo, daily administered 1 hour before bedtime.

Primary Outcome(s)

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(s)

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 ID(s)

ISRCTN93133646

ZON-MW no: 28-3003

Source(s) of Monetary Support

ZON-MW, The Netherlands Organization for Health Research and Development, Foundation ?De Drie Lichten?, Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ), Japan Foundation for Aging and Health, Hersenstichting Nederland, Philips, Braun, Cambridge Neurotechnology