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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
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00946530
First received: July 23, 2009
Last updated: October 13, 2010
Last verified: October 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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.
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946530

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

Publications:

Responsible Party: Jerome A Yesavage, Stanford University School of Medicine
ClinicalTrials.gov 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
Sleep Initiation and Maintenance Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders

ClinicalTrials.gov processed this record on May 16, 2013