Actively Recruiting
A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimers Disease and Their Caregivers
Led by University of California, Los Angeles · Updated on 2025-03-26
672
Participants Needed
3
Research Sites
13 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
Researchers are evaluating the effectiveness of the Care2Sleep behavioral sleep intervention program for people with Alzheimers disease or related dementias and their caregivers. This randomized controlled trial lasts 5 years and focuses on improving sleep quality, health status, quality of life for both patients and caregivers, and inflammation levels in caregivers. The study uses Stage II of the NIH behavioral intervention development model to assess these effects. Participants will be assigned randomly to one of three groups in-person Care2Sleep, telehealth Care2Sleep, or an in-person education control group. Both Care2Sleep programs involve manual-based sleep hygiene recommendations, behavioral sleep intervention, and sleep compression therapy, delivered in five sessions. The education control group receives general information on sleep, aging, and dementia without personalized recommendations. The intervention and control programs start after baseline assessments and randomization. Participants will complete assessments immediately after the last session and again at 6 months to measure sleep efficiency and Pittsburgh Sleep Quality Index scores. Other evaluations include memory and behavior problems, quality of life, caregiver burden, depression, global health, and inflammatory markers. Safety and adherence are monitored, and the total participation duration spans from baseline through a 6-month follow-up.
CONDITIONS
Brief 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 bedbound)
- Experience more than one sleep problem at least three times per week
- Aged over 60 years
- No untreated sleep disorders such as sleep apnea or restless legs syndrome
- Able to walk with or without assistive devices
- No severe medical conditions with life expectancy under 6 months
- Have an eligible caregiver
- Caregivers must live with the patient
- Caregivers aged over 18 years
- Caregivers related as family, significant other, or friend
- Caregivers assist patient regularly with daily living activities for at least 6 months
- Caregivers have a Pittsburgh Sleep Quality Index score over 5
- Caregivers have a Montreal Cognitive Assessment score of 23 or higher
- Caregivers can communicate in English
You will not qualify if you...
- Patients who are bedbound or have severe medical conditions with life expectancy under 6 months
- Paid professional caregivers
- Dyads where either patient or caregiver do not meet eligibility criteria
Research Team
Y
Yeonsu Song
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