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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00946530
First Posted: July 27, 2009
Last Update Posted: March 29, 2017
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.
Collaborator:
Palo Alto Veterans Institute for Research
Information provided by (Responsible Party):
Jerome A Yesavage,, Stanford University
July 23, 2009
July 27, 2009
December 5, 2013
March 29, 2017
March 29, 2017
September 2004
December 2010   (Final data collection date for primary outcome measure)
Total Sleep Time [ Time Frame: 2 weeks ]
The amount of actual sleep time in a sleep episode.
  • improved sleep
  • reduced WASO
  • lengthened TST
Complete list of historical versions of study NCT00946530 on ClinicalTrials.gov Archive Site
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.
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
  • Device: Bright light
    Participants uses bright light
  • Device: Control
    Participants uses dim light
  • Experimental: Bright Light
    received bright light
    Intervention: Device: Bright light
  • Placebo Comparator: Control
    received regular light
    Intervention: Device: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
December 2010
December 2010   (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
Sexes Eligible for Study: All
55 Years to 100 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00946530
SU-06302009-2840
1677 ( Other Identifier: Stanford University IRB )
No
Not Provided
Plan to Share IPD: No
Plan Description: This was not required at the time.
Jerome A Yesavage,, Stanford University
Stanford University
Palo Alto Veterans Institute for Research
Principal Investigator: Jerome A Yesavage Stanford University
Stanford University
December 2016

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