Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease

Study Overview
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Brief Summary
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The aim of this study is to demonstrate the efficacy of timed exposure to bright light for the treatment of disturbed nighttime sleep and daytime wake in community-dwelling dementia patients and their caregivers, and to determine if there are genetic relationships between memory problems and sleep problems

Detailed Description
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Efficacy: Up to 4 weeks of morning bright light exposure will be more efficacious than morning dim light in consolidating nighttime sleep as assessed by actigraphy. Predictors of response: We expect the primary predictor of treatment response will be initial MMSE score. Secondary predictors include baseline sleep/wake and circadian parameters and age. Effectiveness: Bright light treatment will be more effective than dim light in improving quality of life. An understanding of some of the genetic markers of memory and/or sleep problems.

Official Title
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Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Device: Bright light
* Device: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Alzheimer's Disease Patients: Stanford Alzheimer's Disease Core Center member or potential member, with diagnostic criteria met for probable AD, living with caregiver willing to participate in the protocol Non-institutionalized Caregivers: Living in home of AD patient and willing to participate in protocol Exclusion Criteria:Alzheimer's Disease Patients: History of manic or bipolar disorder Prior bright light treatment Irregular or non-24 hour sleep/wake cycle Positive result on multi-staged RLS/PLMD Medical/Ophthalmologic Exclusions RDI >20 on overnight EdenTrace® recording Caregivers: History of manic or bipolar disorder Medical/Ophthalmologic Exclusions

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 100 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright Light<br>received bright light | Device: Bright light<br>* Participants uses bright light<br>|
| Placebo Comparator: Control<br>received regular light | Device: Control<br>* Participants uses dim light<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time | The amount of actual sleep time in a sleep episode. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WASO (Wake After Sleep Onset) | WASO (Wake After Sleep Onset): the amount of time test subjects have spent awake after initially falling sleep and before they awaken for good. | 2 weeks |