Contact information
Type
Scientific
Contact name
Dr R F Riemersma-van der Lek
ORCID ID
Contact details
Netherlands Institute for Brain Research
Meibergdreef 33
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 5488
r.riemersma@nih.knaw.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
ZonMw no: 28-3003; NTR83
Study information
Scientific title
Acronym
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.
Ethics approval(s)
Ethics approval received from the local medical ethics committee
Study design
Randomised, placebo-controlled, parallel group, single blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
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
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 measures
No secondary outcome measures
Overall study start date
01/06/1999
Overall study end date
01/04/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Demented elderly, living in the assisted care facilities of 12 different homes for the elderly in different places in the Netherlands.
Participant type(s)
Patient
Age group
Senior
Sex
Both
Target number of participants
189
Participant exclusion criteria
Does not comply with the above inclusion criteria
Recruitment start date
01/06/1999
Recruitment end date
01/04/2003
Locations
Countries of recruitment
Netherlands
Study participating centre
Netherlands Institute for Brain Research
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Netherlands Institute for Brain Research (The Netherlands)
Sponsor details
Meibergdreef 33
Amsterdam
1105 AZ
Netherlands
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
Hersenstichting Nederland (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Japan Foundation for Aging and Health (Japan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Foundation 'De Drie Lichten' (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cambridge Neurotechnology (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Braun (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Philips (The Netherlands)
Alternative name(s)
Koninklijke Philips N.V., Royal Philips, Royal Philips N.V.
Funding Body Type
government organisation
Funding Body Subtype
For-profit companies (industry)
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 11/06/2008 | Yes | No |