Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
Recruitment status was Active, not recruiting
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease|
- improved sleep [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- reduced WASO [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- lengthened TST [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Improved quality of life as measured by SF-36 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946530
|United States, California|
|VA Palo Alto Health Care System|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Jerome A Yesavage||Stanford University|