Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2

Study Overview
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Brief Summary
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Aim 2 will investigate the effect of 3 different light exposure lengths on sleep, mood and agitation in persons with Alzheimer's disease. Participants will be randomly assigned to one of three conditions of light exposure: 1) 2-h morning light exposure; 2) 4-h morning light exposure; and 3) all day light exposure.

Official Title
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Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2

Conditions
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Alzheimer's Disease, Sleep Disturbance

Intervention / Treatment
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* Device: Active Lighting Intervention
* Device: Control Lighting Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Alzheimer's disease or related dementia with a Montreal Cognitive Assessment score <25 Sleep disturbance with a Pittsburgh Sleep Quality Index score ≥5 Exclusion Criteria: Extensive brain vascular disease, traumatic brain injury, multiple sclerosis, Parkinson's Disease Obstructing cataracts Severe macular degeneration Use of sleep medication Use of oral melatonin untreated moderate to severe sleep apnea Severe restless leg syndrome 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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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Lighting Intervention<br>Lighting intervention designed to effect the circadian system then will receive the control lighting intervention. | Device: Active Lighting Intervention<br>* Lighting intervention using high light levels designed to effect the circadian system<br>Device: Control Lighting Intervention<br>* Lighting intervention using low light levels designed to not effect the circadian system<br>|
| Placebo Comparator: Control Lighting Intervention<br>Lighting intervention using low light levels designed to not effect the circadian system | Device: Control Lighting Intervention<br>* Lighting intervention using low light levels designed to not effect the circadian system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Disturbance using the Pittsburgh Sleep Quality Index | The PSQI is used to measure sleep quality and is composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each subscale is scored 0 to 3. The sum of the 7 component scores yields a single global score with a range of 0 to 21. A higher score indicates higher sleep disturbance | up to week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency using actigraphy | Actigraphs will be worn continuously for 7 days during each assessment week. Changes in sleep efficiency will be measured using the actigraphy software. Sleep efficiency is a calculated as a ratio of the time spent in bed and the time spent sleeping. | up to week 14 | 
| Depression using the Cornell Scale for Depression in Dementia (CSDD) | The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. This tool evaluates the presence and extent of mood-related signs (anxiety, sadness, irritability), behavioral disturbances (agitation, loss of interest), physical signs (loss of appetite, weight loss), cyclic functions (mood variation, sleep quality), and ideational disturbances. Scores range from 0 to 38 with a higher score indicating greater depression. | up to week 14 | 
| Agitation using the Cohen-Mansfield Agitation Inventory (CMAI) | The CMAI assesses the frequency of manifestations of agitated behaviors in elderly persons. The CMAI is a caregivers' rating questionnaire consisting of 29 agitated behaviors, each rated on a 7-point scale of frequency. Score ranges from 30 to 210 with a higher score indicating higher agitated behavior. | up to week 14 | 
| Light measurements using the Daysimeter | Circadian light measurements will be collected during waking hours for 7 days each assessment week using the daysimeter. The light measurement is reported as Lux levels. | up to week 14 | 
| Cognitive status Using the Montreal Cognitive Assessment (MOCA) | The MoCA is a 1-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. Total score range from 0 to 30. Lower score indicates lower cognitive status. | up to week 14 |