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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2010-12-31

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

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Detailed Description

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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.

Conditions

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Sleep Initiation and Maintenance Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Bright Light

received bright light

Group Type EXPERIMENTAL

Bright light

Intervention Type DEVICE

Participants uses bright light

Control

received regular light

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DEVICE

Participants uses dim light

Interventions

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Bright light

Participants uses bright light

Intervention Type DEVICE

Control

Participants uses dim light

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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:

Exclusion Criteria

* 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

Minimum Eligible Age

55 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes