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

Stanford University118 enrolled

Overview

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

1. 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. 2. 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. 3. Effectiveness: Bright light treatment will be more effective than dim light in improving quality of life. 4. An understanding of some of the genetic markers of memory and/or sleep problems.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

118

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Bright lightDEVICE

Participants uses bright light

ControlDEVICE

Participants uses dim light

Eligibility

Sex: ALLMin age: 55 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

VA Palo Alto Health Care System

Palo Alto, California, United States

Outcomes

Primary Outcomes

Total Sleep Time

The amount of actual sleep time in a sleep episode.

Time frame: 2 weeks

Secondary Outcomes

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.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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