Methodology Issues in a Tailored Light Treatment for Persons With Dementia

Study Overview
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Brief Summary
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Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia

Detailed Description
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In a within subjects, randomized placebo control study, a tailored light treatment will be used for short-term (4 weeks). Outcome measures include sleep measures (actigraphy), and questionnaires probing behavior and mood in those who have been diagnosed with Alzheimer's disease and related dementia. After a 4-week washout period, a placebo control inactive light will be used for another 4 weeks.

Official Title
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Phase 1 Methodology Issues in a Tailored Light Treatment for Persons With Dementia

Conditions
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Sleep Disturbances, Depression

Intervention / Treatment
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* Other: Tailored Active intervention
* Other: Inactive intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild to moderate Alzheimer's disease and related dementia (ADRD) Exclusion Criteria: major organ failure, major illness, history of head injury, hypertension or diabetes, use psychotropic (sleep aid) medicine, obstructing cataracts, macular degeneration, and blindness

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Intervention<br>Light levels, primary and secondary measurements are obtained after a 4-week intervention period where active lighting is experienced by patients. | Other: Tailored Active intervention<br>* Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.<br>|
| Placebo Comparator: Inactive intervention<br>Light levels, primary and secondary measurements are obtained after a 4-week intervention period where an inactive lighting is experienced by patients | Other: Inactive intervention<br>* Subjects experience a baseline for 1 week and an inactive intervention for 4 weeks. The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Disturbance | Caregivers and subjects are asked to complete the Pittsburgh Sleep Quality Index (PSQI), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The seven component scores are summed to provide a global score ranging from 0 to 21 and a score of 5 or above indicates sleep disturbance. A higher number indications a greater sleep disturbance | Change from Baseline (week 0) and intervention (week 4) | 
| Agitation | Caregivers and subjects are asked to fill out the Cohen-Mansfield Agitation Score, which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. All scores are summed for one total score - a higher score indicates more agitation | Change from Baseline (week 0) and intervention (week 4) | 
| Depression | Caregivers and subjects are asked to fill out subjective questionnaires assessing depression using the Cornell Scale for Depression in Dementia (CSDD) Questionnaires are assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The CSDD consists of 19 questions rated on a scale of 0 to 2 with all scores summed for a total score. A score greater than 12 indicates depression and a higher score indicates greater depression. | Change from Baseline (week 0) and intervention (week 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity of Daily Living | Caregivers and subjects are asked to fill out subjective Activity of Daily Living questionnaire (MDS-ADL), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. Scores range from 4 to 18 and a higher score indicates a higher dependence. | Change from Baseline (week 0) and intervention (week 4) | 
| Light/dark patterns | Subjects are asked to wear a calibrated light meter to obtain light/dark and activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. These data are used to determine circadian disruption (correlation between light/dark and activity/rest) and light dose. | Change from Baseline (week 0) and intervention (week 4) | 
| Actigraphy | Subjects are asked to wear an actigraph to obtain activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. Actigraphs are used to measure sleep efficiency. | Change from Baseline (week 0) and intervention (week 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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light treatment, circadian rhythms, sleep, agitation, depression