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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

July 23, 2009
October 13, 2010
September 2004
December 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • improved sleep
  • reduced WASO
  • lengthened TST
Complete list of historical versions of study NCT00946530 on ClinicalTrials.gov Archive Site
Improved quality of life as measured by SF-36 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
improved quality of life as measured by SF-36
Not Provided
Not Provided
 
Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease

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

  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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
Device: Bright light
Not Provided
Spira AP, Friedman L, Beaudreau SA, Ancoli-Israel S, Hernandez B, Sheikh J, Yesavage J. Sleep and physical functioning in family caregivers of older adults with memory impairment. Int Psychogeriatr. 2010 Mar;22(2):306-11. Epub 2009 Nov 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
110
December 2010
December 2008   (final data collection date for primary outcome measure)

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
Both
55 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00946530
SU-06302009-2840, 1677
Not Provided
Jerome A Yesavage, Stanford University School of Medicine
Stanford University
Not Provided
Principal Investigator: Jerome A Yesavage Stanford University
Stanford University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP