Status:
COMPLETED
A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers
Lead Sponsor:
University of California, Los Angeles
Conditions:
Sleep
Alzheimer Disease
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
Studies consistently show the negative health impact of sleep problems in both Alzheimer's disease (AD) patients and their caregivers. However, only a few sleep interventions have been conducted for A...
Detailed Description
In 2015, Americans provided 18 billion hours of unpaid care for patients with Alzheimer's disease (AD) and other dementias, with an economic value of $221 billion. This estimate may be even higher amo...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Alzheimer's disease (AD) patients:
- AD diagnosis OR probable or possible AD as documented in electronic medical record, which includes Mini Mental State Exam score \>12 (indicating mild to moderate severity of AD) and neuroimaging evidence
- Community-dwelling
- \>1 sleep problem \>3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale
- Aged \>60 years
- Able to ambulate with or without assistive device
- Have an eligible caregiver (see below)
- Inclusion Criteria for caregivers:
- Live with an eligible patient
- Aged \>21 years
- Have regularly assisted patient with \>1 of 6 basic activities of daily living (ADLs) (i.e., bathing, dressing, toileting, transfers, continence, feeding) or \>1 of 8 Instrumental ADL (IADLs) (i.e., using the telephone, shopping, preparing meals, housekeeping, laundry, transportation, taking medicine, managing money) for the past 6 months
- Pittsburgh Sleep Quality Index (PSQI) total score \>5
- Montreal Cognitive Assessment (MoCA) score \>= 23
- Can communicate in English
- Exclusion Criteria:
- \- If AD patient is bed bound
Exclusion
Key Trial Info
Start Date :
September 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03455569
Start Date
September 11 2018
End Date
February 1 2023
Last Update
July 12 2024
Active Locations (2)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
Veterans Affairs Greater Los Angeles Healthcare System
North Hills, California, United States, 91343