This trial is active, not recruiting.

Condition sleep initiation and maintenance disorders
Treatment bright light
Sponsor Stanford University
Start date September 2004
End date December 2008
Trial size 110 participants
Trial identifier NCT00946530, 1677, SU-06302009-2840


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment

Primary Outcomes

improved sleep
time frame: 6 months
reduced WASO
time frame: 6 months
lengthened TST
time frame: 6 months

Secondary Outcomes

Improved quality of life as measured by SF-36
time frame: 2 months

Eligibility Criteria

Male or female participants at least 55 years old.

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

Additional Information

Official title Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
Principal investigator Jerome A Yesavage
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by Stanford University.