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Clinical Trials/NCT00946530
NCT00946530
Completed
Not Applicable

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

Stanford University1 site in 1 country118 target enrollmentSeptember 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Initiation and Maintenance Disorders
Sponsor
Stanford University
Enrollment
118
Locations
1
Primary Endpoint
Total Sleep Time
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 2004
End Date
December 2010
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jerome A Yesavage,

Professor of Psychiatry

Stanford University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Total Sleep Time

Time Frame: 2 weeks

The amount of actual sleep time in a sleep episode.

Secondary Outcomes

  • WASO (Wake After Sleep Onset)(2 weeks)

Study Sites (1)

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