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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00183378 |
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).
Condition | Intervention |
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Alzheimer Disease Sleep Initiation and Maintenance Disorders |
Behavioral: Walking Program Behavioral: Light Exposure Program Behavioral: Combined Education, Walking and Light Exposure Program Behavioral: Routine Medical Care with Education |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Behavioral Treatment of Nocturnal Disturbances in Alzheimer's Disease |
Estimated Enrollment: | 136 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Routine medicare care with education: therapist provides information about the nature of sleep changes in people with Alzheimer's disease and information about treatments for insomnia.
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Behavioral: Routine Medical Care with Education
The therapist provides information to the caregiver about the nature of sleep changes in people with Alzheimer's disease and information about treatments for insomnia. Participants are free to use whatever medical services they wish during study participation.
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2: Active Comparator
Walking: the therapist introduces a walking program and assists the caregiver in establishing a daily walking routine of 30 minutes for the study participant.
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Behavioral: Walking Program
The therapist introduces a walking program and assists the caregiver in establishing a daily walking routine of 30 minutes for the study participant.
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3: Active Comparator
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 light is one hour.
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Behavioral: 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 light is one hour.
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4: Active Comparator
Combination: the therapist does all three of the treatments: routine medical care with education, walking, and light exposure.
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Behavioral: Combined Education, Walking and Light Exposure Program
The therapist provides a combination of education, walking, and light exposure treatments.
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Nocturnal disturbances, such as getting out of bed repeatedly, having hallucinations, talking or singing in bed, and waking up confused are common among patients with AD. Such nocturnal disturbances are associated with increased physical and psychological morbidity in both AD patients and their caregivers and are a major risk factor for patient institutionalization. Nonpharmacologic treatments for these disturbances are needed. This study will assign AD patients to one of four different treatments to determine which is most effective in reducing nocturnal disturbances.
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 both the walking and the light exposure program visits. Participants assigned to receive education about night disturbances associated with Alzheimer's disease will not receive any treatment in the study, but will continue their usual treatment outside of the study.
Participants will be assessed at study entry and at Months 2 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 assess participants. A follow-up visit will occur 6 months after study completion; at the follow-up visit, participants and their caregivers will be interviewed about the participants' nocturnal disturbances.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Alzheimer's Disease Patients:
Exclusion Criteria for Alzheimer's Disease Patients:
Inclusion Criteria for Family Caregiver:
Contact: Amy Moore, MS | 206-616-5550 | amoore@u.washington.edu |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Amy Moore, MS 206-616-5550 amoore@u.washington.edu | |
Principal Investigator: Susan M. McCurry, PhD |
Principal Investigator: | Susan M. McCurry, PhD | University of Washington |
Responsible Party: | University of Washington ( Susan M. McCurry, PhD ) |
Study ID Numbers: | R01 MH072736, DATR A4-GPS |
Study First Received: | September 13, 2005 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00183378 History of Changes |
Health Authority: | United States: Federal Government |
Alzheimer's Disease Insomnia Sleep Problems Elderly Caregivers |
Sleep Initiation and Maintenance Disorders Alzheimer Disease Sleep Disorders Dyssomnias Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Cognition Disorders Sleep Disorders, Intrinsic Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia Delirium |
Sleep Initiation and Maintenance Disorders Alzheimer Disease Nervous System Diseases Central Nervous System Diseases Dyssomnias Sleep Disorders Brain Diseases |
Neurodegenerative Diseases Sleep Disorders, Intrinsic Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia Tauopathies |