Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05452031

Conditions

Sleep

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Care2Sleep

Sleep Education

Study Details

Brief 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

Study ID

NCT05452031

Start date

Nov 9, 2022

Status verified date

Jun, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

672 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

Care2Sleep

A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.

Sleep Education

This group will receive information about 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 ]
  • Pittsburgh Sleep Quality Index score [ Time Frame: Change from Baseline Pittsburgh Sleep Quality Index score at 6 months ]

Central Contacts and Locations

Central contacts

Yeonsu Song

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

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Brent Mausbach, PhD

858-822-7529bmausbach@health.ucsd.edu

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Yeonsu Song, PhD

Veterans Affairs Greater Los Angeles Healthcare System

Recruiting

Los Angeles, California, United States, 91343

Contacts

Yeonsu Song, PhD

818-891-7711

Principal Investigator:

Yeonsu Song, PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Dementia
  • Caregivers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-06-18.