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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00946530
Recruitment Status : Completed
First Posted : July 27, 2009
Results First Posted : March 29, 2017
Last Update Posted : October 3, 2018
Palo Alto Veterans Institute for Research
Information provided by (Responsible Party):
Jerome A Yesavage,, Stanford University

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

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Device: Bright light Device: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
Study Start Date : September 2004
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Bright Light
received bright light
Device: Bright light
Participants uses bright light

Placebo Comparator: Control
received regular light
Device: Control
Participants uses dim light

Primary Outcome Measures :
  1. Total Sleep Time [ Time Frame: 2 weeks ]
    The amount of actual sleep time in a sleep episode.

Secondary Outcome Measures :
  1. WASO (Wake After Sleep Onset) [ Time Frame: 2 weeks ]
    WASO (Wake After Sleep Onset): the amount of time test subjects have spent awake after initially falling sleep and before they awaken for good.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946530

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United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Palo Alto Veterans Institute for Research
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Principal Investigator: Jerome A Yesavage Stanford University
Publications of Results:
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Responsible Party: Jerome A Yesavage,, Professor of Psychiatry, Stanford University Identifier: NCT00946530    
Other Study ID Numbers: SU-06302009-2840
1677 ( Other Identifier: Stanford University IRB )
First Posted: July 27, 2009    Key Record Dates
Results First Posted: March 29, 2017
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This was not required at the time.
Additional relevant MeSH terms:
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Alzheimer Disease
Sleep Initiation and Maintenance Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders