Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease
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Purpose
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 |
|---|---|
|
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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Behavioral Treatment of Nocturnal Disturbances in Alzheimer's Disease |
- Patient total wake time (actigraphy) [ Time Frame: Measured 3 times over 6 months ] [ Designated as safety issue: No ]
- Caregiver reports of patient behavioral disturbances at night (Sleep Disorders Inventory) [ Time Frame: Measured 3 times over 6 months ] [ Designated as safety issue: No ]
- Additional patient actigraphy outcomes [ Time Frame: Measured 3 times over 6 months ] [ Designated as safety issue: No ]
- Patient daytime sleepiness, behavioral problems, and residential status [ Time Frame: Measured 3 times over 6 months ] [ Designated as safety issue: No ]
- Caregiver sleep [ Time Frame: Measured 3 times over 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 132 |
| Study Start Date: | September 2005 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
Behavioral: 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.
|
|
Active Comparator: 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.
|
Behavioral: 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.
|
|
Active Comparator: 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.
|
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 bright light is one hour.
|
|
Active Comparator: 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.
|
Behavioral: 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.
|
Detailed Description:
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 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.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria for Alzheimer's Disease Patients:
- 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
Exclusion Criteria for Alzheimer's Disease Patients:
- Pre-existing diagnosis of a primary sleep disorder, such as sleep apnea or periodic limb movement disorder
- Blindness
- Current use of photosensitizing medication
Inclusion Criteria for Family Caregiver:
- Currently caring for a family member with Alzheimer's disease
Contacts and Locations| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | Susan M. McCurry, PhD | University of Washington |
More Information
Publications:
| Responsible Party: | Sue McCurry, Research Professor, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00183378 History of Changes |
| Other Study ID Numbers: | R01 MH072736, R01MH072736, DATR A4-GPS |
| Study First Received: | September 13, 2005 |
| Last Updated: | January 12, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Washington:
|
Alzheimer's Disease Insomnia Sleep Problems Elderly Caregivers |
Additional relevant MeSH terms:
|
Alzheimer Disease Sleep Initiation and Maintenance Disorders Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders |
ClinicalTrials.gov processed this record on May 16, 2013