Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease
Behavioral Treatment of Nocturnal Disturbances in Alzheimer's Disease
2 other identifiers
interventional
132
1 country
1
Brief Summary
This study will compare four different behavioral treatment programs to determine which is most effective in reducing night-time disturbances in individuals with Alzheimer's disease (AD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable alzheimer-disease
Started Sep 2005
Longer than P75 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJanuary 13, 2012
January 1, 2012
4 years
September 13, 2005
January 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient total wake time (actigraphy)
Measured 3 times over 6 months
Caregiver reports of patient behavioral disturbances at night (Sleep Disorders Inventory)
Measured 3 times over 6 months
Secondary Outcomes (3)
Additional patient actigraphy outcomes
Measured 3 times over 6 months
Patient daytime sleepiness, behavioral problems, and residential status
Measured 3 times over 6 months
Caregiver sleep
Measured 3 times over 6 months
Study Arms (4)
1
ACTIVE COMPARATORRoutine medical care with education: therapist provides information about the nature of sleep changes in people with Alzheimer's disease, general information about treatments for insomnia, and caregiver support.
2
ACTIVE COMPARATORWalking: the therapist introduces a walking program and assists the caregiver in establishing a daily walking routine of 30 minutes for the study participant.
3
ACTIVE COMPARATORLight exposure: the therapist provides a light box and teaches the caregiver how to use the box so that the study participant's daily exposure to bright light is one hour.
4
ACTIVE COMPARATORCombination: the therapist provides education plus assistance setting up an individualized sleep program, a daily walking routine, and a schedule for daily light exposure.
Interventions
The therapist introduces a walking program and assists the caregiver in establishing a walking routine of 30 minutes/day for the study participant.
The therapist provides a light box and teaches the caregiver how to use the box so that the study participant's daily exposure to bright light is one hour.
The therapist provides a combination of education plus assistance setting up an individualized sleep program, a daily walking routine, and a schedule for daily light exposure.
The therapist provides information about the nature of sleep changes in people with Alzheimer's disease, general information about treatments for insomnia, and caregiver support. Participants are free to use whatever medical services they wish during study participation.
Eligibility Criteria
You may qualify if:
- Diagnosis of probable or possible Alzheimer's Disease
- Have at least two sleep disturbances, occurring 3 or more times per week
- Reside in a residential home with a family member caregiver
- Able to walk without assistance
You may not qualify if:
- Pre-existing diagnosis of a primary sleep disorder, such as sleep apnea or periodic limb movement disorder
- Blindness
- Current use of photosensitizing medication
- Currently caring for a family member with Alzheimer's disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
Related Publications (4)
McCurry SM, Gibbons LE, Logsdon RG, Vitiello M, Teri L. Training caregivers to change the sleep hygiene practices of patients with dementia: the NITE-AD project. J Am Geriatr Soc. 2003 Oct;51(10):1455-60. doi: 10.1046/j.1532-5415.2003.51466.x.
PMID: 14511168BACKGROUNDMcCurry SM, Gibbons LE, Logsdon RG, Vitiello MV, Teri L. Nighttime insomnia treatment and education for Alzheimer's disease: a randomized, controlled trial. J Am Geriatr Soc. 2005 May;53(5):793-802. doi: 10.1111/j.1532-5415.2005.53252.x.
PMID: 15877554BACKGROUNDMcCurry SM, Pike KC, Logsdon RG, Vitiello MV, Larson EB, Teri L. Predictors of short- and long-term adherence to a daily walking program in persons with Alzheimer's disease. Am J Alzheimers Dis Other Demen. 2010 Sep;25(6):505-12. doi: 10.1177/1533317510376173. Epub 2010 Jul 26.
PMID: 20660515RESULTMcCurry SM, Pike KC, Vitiello MV, Logsdon RG, Larson EB, Teri L. Increasing walking and bright light exposure to improve sleep in community-dwelling persons with Alzheimer's disease: results of a randomized, controlled trial. J Am Geriatr Soc. 2011 Aug;59(8):1393-402. doi: 10.1111/j.1532-5415.2011.03519.x. Epub 2011 Jul 28.
PMID: 21797835RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan M. McCurry, PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
September 1, 2005
Primary Completion
September 1, 2009
Study Completion
March 1, 2011
Last Updated
January 13, 2012
Record last verified: 2012-01