Actively Recruiting
A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
Led by University of California, Los Angeles · Updated on 2025-03-26
672
Participants Needed
3
Research Sites
250 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
U
University of California, San Diego
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). Eligible participants will be randomly assigned to in-person Care2Sleep, telehealth Care2Sleep, or to an in-person education control group. The Care2Sleep programs and the control education program will consist of five sessions. The intervention and control programs will begin after baseline assessment and randomization. Posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.
CONDITIONS
Official Title
A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a diagnosis of Alzheimer's disease (probable or possible) or related dementia documented in medical records
- Live in the community (not institutionalized)
- Have more than one sleep problem occurring more than three times per week
- Be aged over 60 years
- Have no untreated sleep disorders such as sleep apnea or restless legs syndrome
- Be able to walk with or without assistive devices (not bedbound)
- Have no severe medical conditions with life expectancy under 6 months
- Have an eligible caregiver
- Caregivers must live with the patient
- Caregivers must be aged over 18 years
- Caregivers must be family, significant other, or friend
- Caregivers must have regularly helped with at least one basic or instrumental activity of daily living for the past 6 months
- Caregivers must have a Pittsburgh Sleep Quality Index score over 5
- Caregivers must have a Montreal Cognitive Assessment score of 23 or higher
- Caregivers must be able to communicate in English
You will not qualify if you...
- Patients who are bedbound
- Patients with severe medical conditions and life expectancy less than 6 months
- Paid, professional caregivers
- Dyads where either the patient or caregiver does not meet eligibility criteria
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
2
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, United States, 91343
Actively Recruiting
Research Team
Y
Yeonsu Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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