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The effect of light and/or melatonin on sleep, mood, cognition and behavior in demented elderly
ISRCTN ISRCTN93133646
DOI 10.1186/ISRCTN93133646
ClinicalTrials.gov identifier
EudraCT number
Public title The effect of light and/or melatonin on sleep, mood, cognition and behavior in demented elderly
Scientific title
Acronym N/A
Serial number at source ZonMw no: 28-3003; NTR83
Study hypothesis 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.
Lay summary
Ethics approval Ethics approval received from the local medical ethics committee
Study design Randomised, placebo-controlled, parallel group, single blinded trial
Countries of recruitment Netherlands
Disease/condition/study domain Dementia, dementia symptoms
Participants - inclusion criteria Demented elderly, living in the assisted care facilities of 12 different homes for the elderly in different places in the Netherlands.
Participants - exclusion criteria Does not comply with the above inclusion criteria
Anticipated start date 01/06/1999
Anticipated end date 01/04/2003
Status of trial Completed
Patient information material
Target number of participants 189
Interventions 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.
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.
Secondary outcome measure(s) No secondary outcome measures
Sources of funding 1. Hersenstichting Nederland (The Netherlands)
2. Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ) (The Netherlands)
3. Japan Foundation for Aging and Health (Japan)
4. Foundation 'De Drie Lichten' (The Netherlands)
5. Cambridge Neurotechnology (UK)
6. Braun (The Netherlands)
7. The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
8. Philips (The Netherlands)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18544724
Contact name Dr  R F  Riemersma-van der Lek
  Address Netherlands Institute for Brain Research
Meibergdreef 33
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Tel +31 (0)20 566 5488
  Email r.riemersma@nih.knaw.nl
Sponsor Netherlands Institute for Brain Research (The Netherlands)
  Address Meibergdreef 33
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
Date applied 12/09/2005
Last edited 18/07/2008
Date ISRCTN assigned 12/09/2005
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