Contact information
Type
Scientific
Primary contact
Dr Eus J.W. Van Someren
ORCID ID
Contact details
Netherlands Institute for Neuroscience
Meibergdreef 47
Amsterdam
1105 BA
Netherlands
e.van.someren@nin.knaw.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZonMW project ref: 0028.300.30; METc VUmc protocol ref: 2005/10
Study information
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
Acronym
Study hypothesis
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
Medical Ethical Committee of the VU University Medical Centre (METc VUmc), approved on 03/08/2005 (Protocol 2005/10)
Study design
Single centre randomised double blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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'.
All primary and secondary outcomes will be assessed at 1 pre-randomisation assessment and 4 half-yearly post-randomisation assessments (i.e. 2 years of follow-up).
Secondary outcome measures
1. Subjective sleep is measured with the Athens Insomnia Scale, the Dutch Sleep Disorders Questionnaire and the Pittsburg Sleep Quality Index
2. Cognition is measured with a neuropsychological test battery
3. 24-hour recording of skin temperature (9 temperature loggers are placed on thighs, abdomen, soles of the hands and feet), and of heart rate
4. Two weeks monitoring of rest-activity rhythms by actometry
5. Bed times are estimated with a pressure pad connected to a data logger, placed on the patients' bed
6. Saliva samples are collected on one day, from which the diurnal pattern of cortisol levels are determined
7. The primary caregiver fills out the Zarit Burden Interview and the Self-Perceived Pressure from Informal Care questionnaire
All primary and secondary outcomes will be assessed at 1 pre-randomisation assessment and 4 half-yearly post-randomisation assessments (i.e. 2 years of follow-up).
Overall trial start date
01/05/2005
Overall trial end date
01/08/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
72 patients (36 in each limb of the random assignment) + 25 healthy controls
Participant 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
Recruitment start date
01/05/2005
Recruitment end date
01/08/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Netherlands Institute for Neuroscience
Amsterdam
1105 BA
Netherlands
Sponsor information
Organisation
Netherlands Institute for Neuroscience (Netherlands)
Sponsor details
Meibergdreef 47
Amsterdam
1105 BA
Netherlands
secretariaat@nin.knaw.nl
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), Prevention Programme (ref: 0028.300.30)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Netherlands Organisation for Scientific Research (NWO) (Netherlands) (ref: 453-07-001)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20178604
Publication citations
-
Protocol
Most EI, Scheltens P, Van Someren EJ, Prevention of depression and sleep disturbances in elderly with memory-problems by activation of the biological clock with light--a randomized clinical trial., Trials, 2010, 11, 19, doi: 10.1186/1745-6215-11-19.