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A Sleep Health Study for Alzheimer's Patients and Caregivers

This study is looking at how a program called Care2Sleep can help people with Alzheimer's disease or other dementias and their caregivers improve their sleep. Care2Sleep involves several behavioral techniques like sleep hygiene and daily walking. Another group will receive general sleep education. Researchers want to see if Care2Sleep improves sleep efficiency (how much time you spend asleep while in bed) and overall sleep quality, as measured by the Pittsburgh Sleep Quality Index. They will also look at health and quality of life for both patients and caregivers, and inflammation for caregivers. You may be able to join if you are over 60, have Alzheimer's or a related dementia, live in the community, and have more than one sleep problem. The study is currently unclear about its recruitment status.

Study design
This is a randomized controlled trial over 5 years, planning to enroll 672 participants. Participants will be randomly assigned to one of three groups: in-person Care2Sleep, telehealth Care2Sleep, or an in-person education control group.
What's involved
The Care2Sleep programs and the control education program will each consist of five sessions. Post-treatment assessments will be done right after the last session and again 6 months later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after the last session.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05452031

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

Recruiting
NAAges 18+InterventionalSupportive care
University of California, Los Angeles
~672 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Care2SleepSleep Education

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sleep efficiency-Actigraphy
Measured over Change from Baseline Sleep Efficiency at 6 months
+1 more outcome measured

Conditions

Sleep

Explore related trials

Alzheimer's DiseaseDementia

Where it's being run

3 sites across 1 states
California3

Who to contact

Yeonsu Song
[email protected]
310-983-3029
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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.

What this trial measures

  • Sleep efficiency-ActigraphyChange from Baseline Sleep Efficiency at 6 months

    Nighttime sleep efficiency (i.e., mean percent of time in bed spent asleep) will be calculated from 7 days of wrist actigraphy for patients and caregivers. Range from 0 to 100% with a higher percent indicating better objective sleep quality

  • Pittsburgh Sleep Quality Index scoreChange from Baseline Pittsburgh Sleep Quality Index score at 6 months

    Self-reported sleep quality over the past week for patients (reported by caregivers) and caregivers. Range from 0 to 21 with lower scores indicating better subjective sleep quality.