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

University of California, Los Angeles · with University of California, San Diego, VA Greater Los Angeles Healthcare System · NCT05452031

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
672
US sites recruiting
3
Study start
November 9, 2022
Record last updated
June 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Care2Sleep; Sleep Education

Conditions: Sleep

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria for Patients

  • 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

Inclusion Criteria for Caregivers

  • Live with an eligible patient
  • Aged >18 years
  • Is related to the patient as a family member, a significant other, or a friend
  • Have regularly assisted patient with >1 of 6 basic activities of daily living (ADLs; i.e., bathing, dressing, toileting, transferring, continence, feeding) or >1 of 8 Instrumental ADL (IADLs; i.e., using the telephone, shopping, food preparation, housekeeping, laundry, transportation, taking medications, managing money) for the past 6 months
  • Pittsburgh Sleep Quality Index (PSQI) total score >5
  • Montreal Cognitive Assessment (MoCA) ≥23
  • Can communicate in English

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.

Recruiting US locations

  • University of California San Diego

    La Jolla, CA 92093

    Site contact: Brent Mausbach, PhD · 858-822-7529 · bmausbach@health.ucsd.edu

  • University of California Los Angeles

    Los Angeles, CA 90095

    Site contact: Yeonsu Song, PhD

  • Veterans Affairs Greater Los Angeles Healthcare System

    Los Angeles, CA 91343

    Site contact: Yeonsu Song, PhD · 818-891-7711

Study contacts (from the official record)

  • Yeonsu Song · 310-983-3029 · ysong@sonnet.ucla.edu
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A Dyadic Sleep Health Approach for Persons With Alzheimer's… (NCT05452031) | Bored Studies