Condition category
Mental and Behavioural Disorders
Date applied
17/09/2009
Date assigned
08/10/2009
Last edited
04/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nin.knaw.nl/

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

  1. 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.

Additional files

Editorial Notes