Welcome
Support Centre
01 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Prevention of depression and sleep disturbances in elderly with memory-problems by activation of the biological clock with light
ISRCTN ISRCTN29863753
DOI 10.1186/ISRCTN29863753
ClinicalTrials.gov identifier
EudraCT number
Public title Prevention of depression and sleep disturbances in elderly with memory-problems by activation of the biological clock with light
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 N/A
Serial number at source ZonMW project ref: 0028.300.30; METc VUmc protocol ref: 2005/10
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
Lay summary
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
Countries of recruitment Netherlands
Disease/condition/study domain Alzheimer dementia, mild cognitive impairment, cognitive deficits
Participants - 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
Participants - 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
Anticipated start date 01/05/2005
Anticipated end date 01/08/2009
Status of trial Completed
Patient information material
Target number of participants 72 patients (36 in each limb of the random assignment) + 25 healthy controls
Interventions 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
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'.

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 measure(s) 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).
Sources of funding 1. The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), Prevention Programme (ref: 0028.300.30)
2. The Netherlands Organisation for Scientific Research (NWO) (Netherlands) (ref: 453-07-001)
Trial website
Publications 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20178604
Contact name Dr  Eus J.W.  Van Someren
  Address Netherlands Institute for Neuroscience
Meibergdreef 47
  City/town Amsterdam
  Zip/Postcode 1105 BA
  Country Netherlands
  Email e.van.someren@nin.knaw.nl
Sponsor Netherlands Institute for Neuroscience (Netherlands)
  Address Meibergdreef 47
  City/town Amsterdam
  Zip/Postcode 1105 BA
  Country Netherlands
  Email secretariaat@nin.knaw.nl
  Sponsor website: http://www.nin.knaw.nl/
Date applied 17/09/2009
Last edited 04/05/2010
Date ISRCTN assigned 08/10/2009
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.