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

ISRCTN	ISRCTN93133646
DOI	https://doi.org/10.1186/ISRCTN93133646
Protocol serial number	ZonMw no: 28-3003; NTR83
Sponsor	Netherlands Institute for Brain Research (The Netherlands)
Funders	Hersenstichting Nederland (The Netherlands), Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ) (The Netherlands), Japan Foundation for Aging and Health (Japan), Foundation 'De Drie Lichten' (The Netherlands), Cambridge Neurotechnology (UK), Braun (The Netherlands), The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands), Philips (The Netherlands)

Submission date: 12/09/2005
Registration date: 12/09/2005
Last edited: 18/07/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr R F Riemersma-van der Lek
Scientific

Netherlands Institute for Brain Research
Meibergdreef 33
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 5488
Email	r.riemersma@nih.knaw.nl

Study information

Primary study design	Interventional
Study design	Randomised, placebo-controlled, parallel group, single blinded trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	A large proportion of the demented elderly show fragmented sleep-wake patterns and disturbed circadian rhythms. It appears that the amplitude of the circadian rhythms is attenuated with age, with an exaggerated decline in demented elderly. Decreased input of entraining stimuli, due to diminished stimulation by environmental light and by lower levels of the pineal hormone melatonin to the SupraChiasmatic Nucleus (SCN), the pacemaker of the circadian timing system, might contribute to these disturbances. So far hopeful results have been found for light and melatonin in relatively small groups of patients. We now want to test the effect in a large group of patients to be able to differentiate the effects according to different subject related co-variables and to test the combination of light and melatonin.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Dementia, dementia symptoms
Intervention	Ceiling mounted indirect bright light (1000 lux in gaze direction) or ceiling mounted placebo light (300 lux in gaze direction), six homes in each condition. Furthermore, all participants were randomised to melatonin (2.5 mg) or placebo, daily administered one hour before bedtime.
Intervention type	Other
Primary outcome measure(s)	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. 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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/04/2003

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	189
Key inclusion criteria	Demented elderly, living in the assisted care facilities of 12 different homes for the elderly in different places in the Netherlands.
Key exclusion criteria	Does not comply with the above inclusion criteria
Date of first enrolment	01/06/1999
Date of final enrolment	01/04/2003

Locations

Countries of recruitment

Netherlands

Study participating centre

Netherlands Institute for Brain Research

Amsterdam
1105 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	11/06/2008		Yes	No