Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease
NCT ID: NCT00183378
Last Updated: 2012-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2005-09-30
2011-03-31
Brief Summary
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Detailed Description
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This study will last 6 months. Participants will be randomly assigned to a walking program, a light exposure program, a "NITE-AD" program, combining the walking and light exposure programs, or routine AD care with nocturnal disturbance education. Walking program participants will have three 1-hour visits with a therapist over an 8-week period. The therapist and the participant will set an initial daily walking goal and develop a plan for gradually increasing the participants' walking to 30 minutes/day, to be increased at a participant-selected pace. Pedometers will be given to participants to monitor daily activity. The therapist will also discuss exercise safety and will review ways to prevent muscle soreness. Light program participants will also have three 1-hour visits with a therapist over 8 weeks. The therapist will develop a daily, caregiver-supervised light exposure plan requiring participants to sit in front of a light box for 1 hour every day. NITE-AD program participants will have six 1-hour visits with a therapist over 8 weeks; their visits will include setting up both walking and the light exposure routines. Participants assigned to education will receive information about about sleep in aging and dementia, but no assistance setting up walking or light exposure plans.
Participants will be assessed at study entry and at Months 2 (post-test) and 6. The sleep patterns of both the patients and the caregivers will be measured. Caregiver reports of patients' night-time behavioral disturbances and readings from an actigraph, a small electronic device worn by participants that records and reports their levels of activity at night, will be used to estimate sleep. The study will also collect data on patient and caregiver mood, stress, and behavior. A follow-up visit will occur 6 months after study completion; at the follow-up visit, the same outcome measures will be collected as at baseline and post-test. Participants will receive 3 biannual phone follow-ups (12, 18, and 24 months) to assess patient residential status and caregiver reports of patient and caregiver sleep.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Routine 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.
Routine Medical Care with Education
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.
2
Walking: the therapist introduces a walking program and assists the caregiver in establishing a daily walking routine of 30 minutes for the study participant.
Walking Program
The therapist introduces a walking program and assists the caregiver in establishing a walking routine of 30 minutes/day for the study participant.
3
Light 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.
Light Exposure Program
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
Combination: the therapist provides education plus assistance setting up an individualized sleep program, a daily walking routine, and a schedule for daily light exposure.
Combined Education, Walking and Light Exposure Program
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.
Interventions
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Walking Program
The therapist introduces a walking program and assists the caregiver in establishing a walking routine of 30 minutes/day for the study participant.
Light Exposure Program
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.
Combined Education, Walking and Light Exposure Program
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.
Routine Medical Care with Education
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
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Inclusion Criteria
* 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
* Currently caring for a family member with Alzheimer's disease
Exclusion Criteria
* Blindness
* Current use of photosensitizing medication
55 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Washington
OTHER
Responsible Party
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Sue McCurry
Research Professor
Principal Investigators
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Susan M. McCurry, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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References
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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.
McCurry 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.
McCurry 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.
McCurry 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.
Other Identifiers
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