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A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT05452031•University of California, Los Angeles

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Have a diagnosis of Alzheimer's disease (probable or possible) or other related dementia as documented in an electronic medical record
•Community-dwelling
•\>1 sleep problems \>3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale, - - Aged \>60 years
•Have no untreated sleep disorders (e.g., sleep apnea, restless legs syndrome)
•Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound)
•Have no severe medical conditions with a life expectancy of less than 6 months
•Have an eligible caregiver
•Live with an eligible patient
•Aged \>18 years
•Is related to the patient as a family member, a significant other, or a friend
+4 more criteria

Exclusion Criteria

•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.

Locations (3)

University of California San Diego

La Jolla, California, United States

University of California Los Angeles

Los Angeles, California, United States

Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, United States

Key Dates

Start Date

November 9, 2022

Primary Completion Date

May 31, 2027

Completion Date

August 31, 2027

Last Updated

March 26, 2025

Enrollment

672

ESTIMATED participants

Conditions

Sleep

Interventions

Care2Sleep

BEHAVIORAL

Sleep Education

BEHAVIORAL

Contacts

Yeonsu Song

CONTACT

310-983-3029 ysong@sonnet.ucla.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

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