Back to resultsLight Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
Primary Purpose
Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bright light
Control
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders
Eligibility 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
Sites / Locations
- VA Palo Alto Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bright Light
Control
Arm Description
received bright light
received regular light
Outcomes
Primary Outcome Measures
Total Sleep Time
The amount of actual sleep time in a sleep episode.
Secondary Outcome Measures
WASO (Wake After Sleep Onset)
WASO (Wake After Sleep Onset): the amount of time test subjects have spent awake after initially falling sleep and before they awaken for good.
Full Information
NCT ID
NCT00946530
First Posted
July 23, 2009
Last Updated
October 1, 2018
Sponsor
Stanford University
Collaborators
Palo Alto Veterans Institute for Research
1. Study Identification
Unique Protocol Identification Number
NCT00946530
Brief Title
Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
Official Title
Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Palo Alto Veterans Institute for Research
4. Oversight
Data Monitoring Committee
No
5. 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
Detailed Description
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.
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.
Effectiveness: Bright light treatment will be more effective than dim light in improving quality of life.
An understanding of some of the genetic markers of memory and/or sleep problems.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bright Light
Arm Type
Experimental
Arm Description
received bright light
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
received regular light
Intervention Type
Device
Intervention Name(s)
Bright light
Intervention Description
Participants uses bright light
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Participants uses dim light
Primary Outcome Measure Information:
Title
Total Sleep Time
Description
The amount of actual sleep time in a sleep episode.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
WASO (Wake After Sleep Onset)
Description
WASO (Wake After Sleep Onset): the amount of time test subjects have spent awake after initially falling sleep and before they awaken for good.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerome A Yesavage
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This was not required at the time.
Citations:
PubMed Identifier
19943990
Citation
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. doi: 10.1017/S1041610209991153. Epub 2009 Nov 30.
Results Reference
result
PubMed Identifier
22406033
Citation
Friedman L, Spira AP, Hernandez B, Mather C, Sheikh J, Ancoli-Israel S, Yesavage JA, Zeitzer JM. Brief morning light treatment for sleep/wake disturbances in older memory-impaired individuals and their caregivers. Sleep Med. 2012 May;13(5):546-9. doi: 10.1016/j.sleep.2011.11.013. Epub 2012 Mar 10.
Results Reference
result
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Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
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