Prevention of depression and sleep disturbances in elderly with memory-problems by activation of the biological clock with light
| ISRCTN | ISRCTN29863753 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29863753 |
| Protocol serial number | ZonMW project ref: 0028.300.30; METc VUmc protocol ref: 2005/10 |
| Sponsor | Netherlands Institute for Neuroscience (Netherlands) |
| Funders | The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), Prevention Programme (ref: 0028.300.30), The Netherlands Organisation for Scientific Research (NWO) (Netherlands) (ref: 453-07-001) |
- Submission date
- 17/09/2009
- Registration date
- 08/10/2009
- Last edited
- 04/05/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Netherlands Institute for Neuroscience
Meibergdreef 47
Amsterdam
1105 BA
Netherlands
| e.van.someren@nin.knaw.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised double blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Prevention of depression and sleep disturbances in elderly with memory-problems by activation of the biological clock with light: a double-blind randomised controlled trial |
| Study objectives | 1. Long-term daily bright light exposure attenuates the development of depressive symptoms Secondary hypotheses: 1. Long-term daily bright light exposure attenuates the development of sleep-wake rhythm disturbances 2. Long-term daily bright light exposure ameliorates the decline of cognitive performance 3. Long-term daily bright light exposure ameliorates caregiver burden 4. The effects of light on mood and cognition are in part mediated by its effect on the circadian pacemaker, as read out from the rhythms in activity, body temperature and cortisol |
| Ethics approval(s) | Medical Ethical Committee of the VU University Medical Centre (METc VUmc), approved on 03/08/2005 (Protocol 2005/10) |
| Health condition(s) or problem(s) studied | Alzheimer dementia, mild cognitive impairment, cognitive deficits |
| Intervention | Light boxes installed at the patients' home, 10,000 lux (gaze direction). Identical light box +/-300 lux (gaze direction) are used in the placebo condition. Intervention period is two-years, exposure is daily. Sessions last 30 minutes every morning and evening, during a 90 minutes fixed time-window for both sessions, when light is automatically switched on and cannot be switched off. A maximum of four follow ups, every five to six months. Joint/Secondary Sponsor Details: VU University Medical Centre Department of Neurology Postbox 7057 1007 MB Amsterdam Netherlands Tel: +31 (0)20 4440742 |
| Intervention type | Other |
| Primary outcome measure(s) |
Depression, measured with the Geriatric Depression Scale (GDS), using the complete 30 items version. The GDS is a list of statements and patients are asked to rate whether these statements are applicable to them during the last week, answering 'yes' or 'no'. The range of the cumulative score is 0 to 30; scores labelled: 0-9 as 'not depressed', 10-19 as 'mildly depressed', and 20-30 as 'severely depressed'. |
| Key secondary outcome measure(s) |
1. Subjective sleep is measured with the Athens Insomnia Scale, the Dutch Sleep Disorders Questionnaire and the Pittsburg Sleep Quality Index |
| Completion date | 01/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 97 |
| Key inclusion criteria | 1. For experimental group: 1.1. Patients between 50 and 80 years of age 1.2. Clinical diagnosis of probable (presenile) Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI) or Subjective Memory Complaints provided by a neurologist or gerontologist; AD according to the Diagnosis Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) or the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria and MCI following the MCI-standard set by Petersen (Petersen RC, et al: Neurology 2001, 56(9):1133-1142). 1.3. Mini Mental State Exam (MMSE) score >=14 2. For healthy control group: 2.1. Healthy controls (age 50-80 years) 2.2. Free of any clinical diagnosis of dementia 2.3. Those without subjective memory complaints 2.4. MMSE score ≥28 |
| Key exclusion criteria | Patients nor healthy controls are admitted to the study if any of the following are diagnosed: 1. Any other neurological disorder, including narcolepsy 2. Any psychiatric disorder, with the exception of mild depressive symptoms 3. Serious problems with activities of daily living (ADL) 4. Sleep apnoea or restless legs syndrome 5. A serious eye disease incompatible with light therapy, such as aphakia or retinitis pigmentosa |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 01/08/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1105 BA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/02/2010 | Yes | No |