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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.
ClinicalTrials.gov Identifier: NCT00946530
Recruitment Status : Completed
First Posted : July 27, 2009
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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
Sleep Initiation and Maintenance Disorders Device: Bright light Device: Control

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.

Study Design

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
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00946530


Locations
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
Investigators
Principal Investigator: Jerome A Yesavage Stanford University
More Information

Publications:
Responsible Party: Jerome A Yesavage,, Professor of Psychiatry, Stanford University
ClinicalTrials.gov Identifier: NCT00946530     History of Changes
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: March 29, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This was not required at the time.

Additional relevant MeSH terms:
Alzheimer Disease
Sleep Initiation and Maintenance Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders