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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Stanford University.
Recruitment status was  Active, not recruiting
Information provided by:
Stanford University Identifier:
First received: July 23, 2009
Last updated: October 13, 2010
Last verified: October 2010
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

Condition Intervention
Sleep Initiation and Maintenance Disorders
Device: Bright light

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Improved quality of life as measured by SF-36 [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
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)
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.

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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


-- 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


  • History of manic or bipolar disorder
  • Medical/Ophthalmologic Exclusions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00946530

United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Principal Investigator: Jerome A Yesavage Stanford University
  More Information

Responsible Party: Jerome A Yesavage, Stanford University School of Medicine Identifier: NCT00946530     History of Changes
Other Study ID Numbers: SU-06302009-2840, 1677
Study First Received: July 23, 2009
Last Updated: October 13, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies processed this record on November 24, 2015