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 |
| Secondary identifying numbers | ZonMw no: 28-3003; NTR83 |
- 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
Scientific
Netherlands Institute for Brain Research
Meibergdreef 33
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 5488 |
|---|---|
| r.riemersma@nih.knaw.nl |
Study information
| 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 |
| 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 | 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 |
| Completion date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
1105 AZ
Netherlands
Sponsor information
Netherlands Institute for Brain Research (The Netherlands)
Research organisation
Research organisation
Meibergdreef 33
Amsterdam
1105 AZ
Netherlands
"ROR" |
https://ror.org/05csn2x06 |
|---|
Funders
Funder type
Research organisation
Hersenstichting Nederland (The Netherlands)
No information available
Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ) (The Netherlands)
No information available
Japan Foundation for Aging and Health (Japan)
No information available
Foundation 'De Drie Lichten' (The Netherlands)
No information available
Cambridge Neurotechnology (UK)
No information available
Braun (The Netherlands)
No information available
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Philips (The Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Koninklijke Philips N.V., Royal Philips, Royal Philips N.V., Philips & Co
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 11/06/2008 | Yes | No |
