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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05452031
Status
Recruiting
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Conditions

  • Sleep

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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 Dates

Start date
Nov 9, 2022
Status verified
Mar 2025
Primary completion
May 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
672 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: In-Person Care2Sleep
    In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
  • Active Comparator: Telehealth Care2Sleep
    Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
  • Placebo Comparator: Sleep Education only
    In-person, education on sleep, aging, and dementia but without specific or individualized recommendations

Primary Outcome Measure

Sleep efficiency-Actigraphy [ Time Frame: Change from Baseline Sleep Efficiency at 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093
Brent Mausbach, PhD
[email protected]
858-822-7529
University of California Los AngelesLos AngelesCalifornia90095
Yeonsu Song, PhD
Yeonsu Song, PhD (PRINCIPAL_INVESTIGATOR)
Veterans Affairs Greater Los Angeles Healthcare SystemLos AngelesCalifornia91343
Yeonsu Song, PhD
818-891-7711
Yeonsu Song, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in La Jolla, CA

By research site
University of California San Diego· La Jolla, CAUniversity of California Los Angeles· Los Angeles, CAVeterans Affairs Greater Los Angeles Healthcare System· Los Angeles, CA

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