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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep
• Intervention / Treatment: Behavioral: Care2Sleep; Behavioral: Sleep Education

• Study Type: Interventional
• Enrollment (Estimated): 672
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yeonsu Song; Phone Number: 310-983-3029; Email: ysong@sonnet.ucla.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California San Diego
      • Contact: Brent Mausbach, PhD; Phone Number: 858-822-7529; Email: bmausbach@health.ucsd.edu
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California Los Angeles
      • Contact: Yeonsu Song, PhD
      • Principal Investigator: Yeonsu Song, PhD
    • Los Angeles, California, United States, 91343
      • Recruiting
      • Veterans Affairs Greater Los Angeles Healthcare System
      • Principal Investigator: Yeonsu Song, PhD
      • Contact: Yeonsu Song, PhD; Phone Number: 36069 818-891-7711

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In-Person Care2Sleep; In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy	Behavioral: Care2Sleep; A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.
Active Comparator: Telehealth Care2Sleep; Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy	Behavioral: Care2Sleep; A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.
Placebo Comparator: Sleep Education only; In-person, education on sleep, aging, and dementia but without specific or individualized recommendations	Behavioral: Sleep Education; This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep efficiency-Actigraphy	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	Change from Baseline Sleep Efficiency at 6 months
Pittsburgh Sleep Quality Index score	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.	Change from Baseline Pittsburgh Sleep Quality Index score at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total score of Revised Memory and Behavior Problem Checklist	Dementia-related problem behaviors among persons with dementia (reported by caregivers). Range from 0 to 96 with higher scores indicating more severe dementia-related behaviors.	Immediately AND 6 months after the last session of the intervention
Total score of Quality of Life-Alzheimer's Disease Scale	Quality of life among persons with dementia reported by either caregivers or persons with dementia. Range from 4 to 52 with higher scores indicating better quality of life among persons with dementia	Immediately AND 6 months after the last session of the intervention
Total score of Zarit Burden Interview	Perceived levels of caregiving burden. Range from 0 to 88 with higher scores indicating greater burden among caregivers	Immediately AND 6 months after the last session of the intervention
Total score of Center for Epidemiological Study of Depression Scale	Perceived frequency of depressive symptoms during the past week. Ranges from 0 to 60 with higher scores indicating greater levels of depressive symptoms among caregivers	Immediately AND 6 months after the last session of the intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) global health score	Self-reported physical and mental health scores among caregivers. A T-score of 50 represents the mean of the general population. Higher scores indicate better physical and mental health among caregivers	Immediately AND 6 months after the last session of the intervention
Levels of inflammatory markers	Three key inflammatory markers including C-reactive protein, Tumor necrosis factor-alpha, Interleukin-6 will be collected among caregivers only	Immediately AND 6 months after the last session of the intervention

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: University of California, San Diego; VA Greater Los Angeles Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Dementia; Caregivers
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 1R01AG076756-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Materials generated under the project will be disseminated in accordance with policies at UCLA and NIH. Data products from this study will be made available without cost to researchers, students, and analysts. The final database (both GAD and LAD) will be managed at the UCLA School of Nursing Research Office Design & Data Core. User registration will be required through the Design & Data Core in order to access or download files.
• IPD Sharing Time Frame: Research data that documents, supports, and validates research findings and referenced resource from a publication will be made available by on-line publication date unless NIH policy specifies an earlier date.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No