Prevention of depression and sleep disturbances in elderly with memory-problems by activation of the biological clock with light

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29863753

Enrollment

Registered

2009-10-08

Start date

2005-05-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer dementia, mild cognitive impairment, cognitive deficits Mental and Behavioural Disorders Alzheimer's disease

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, exposur

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026