A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers

Recruiting now · Not applicable

Conditions studied: Sleep

In brief

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.

Key facts

Study ID

NCT05452031

Run by

University of California, Los Angeles

People needed

672

Starts

2022-11-09

Expected to finish

2027-08-31

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Patients will be excluded if they are bedbound or have severe medical conditions with a life expectancy of less than 6 months.
• Paid, professional caregivers will also be excluded.
• If the eligibility criteria for either a patient or a caregiver are not met, the dyads will be excluded for this study.

Where it is running

• University of California San Diego — La Jolla, California, United States (enrolling)
• University of California Los Angeles — Los Angeles, California, United States (enrolling)
• Veterans Affairs Greater Los Angeles Healthcare System — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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