NCT05452031

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

A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 672 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

• Sleep

Interventions

Type	Name	Description
BEHAVIORAL	Care2Sleep	A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.
BEHAVIORAL	Sleep Education	This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations

Timeline

• Start date: 2022-11-09
• Primary completion: 2027-05-31
• Completion: 2027-08-31
• First posted: 2022-07-11
• Last updated: 2025-03-26

Locations

3 sites across 1 country: United States