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
Secondary identifying numbers ZonMW project ref: 0028.300.30; METc VUmc protocol ref: 2005/10
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Eus J.W. Van Someren
Scientific

Netherlands Institute for Neuroscience
Meibergdreef 47
Amsterdam
1105 BA
Netherlands

Email e.van.someren@nin.knaw.nl

Study information

Study designSingle centre randomised double blind placebo controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific titlePrevention 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 objectives1. 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) studiedAlzheimer dementia, mild cognitive impairment, cognitive deficits
InterventionLight 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 typeOther
Primary outcome measureDepression, 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 measures1. 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 study start date01/05/2005
Completion date01/08/2009

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants72 patients (36 in each limb of the random assignment) + 25 healthy controls
Key inclusion criteria1. 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 criteriaPatients 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 enrolment01/05/2005
Date of final enrolment01/08/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Netherlands Institute for Neuroscience
Amsterdam
1105 BA
Netherlands

Sponsor information

Netherlands Institute for Neuroscience (Netherlands)
University/education

Meibergdreef 47
Amsterdam
1105 BA
Netherlands

Email secretariaat@nin.knaw.nl
Website http://www.nin.knaw.nl/
ROR logo "ROR" https://ror.org/05csn2x06

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), Prevention Programme (ref: 0028.300.30)

No information available

The Netherlands Organisation for Scientific Research (NWO) (Netherlands) (ref: 453-07-001)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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