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

NCT05452031 | Recruiting DMC

• 1 other identifier: 1R01AG076756-01
• Study Type: interventional
• Target: 672
• Locations: 1 country
• Sites: 3

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

Keywords

Dementia; Caregivers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Total score of Revised Memory and Behavior Problem Checklist

  Immediately AND 6 months after the last session of the intervention

• Total score of Quality of Life-Alzheimer's Disease Scale

  Immediately AND 6 months after the last session of the intervention

• Total score of Zarit Burden Interview

  Immediately AND 6 months after the last session of the intervention

• Total score of Center for Epidemiological Study of Depression Scale

  Immediately AND 6 months after the last session of the intervention

• Patient-Reported Outcomes Measurement Information System (PROMIS) global health score

  Immediately AND 6 months after the last session of the intervention

Study Arms (3)

In-Person Care2Sleep

EXPERIMENTAL

In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

Behavioral: Care2Sleep

Telehealth Care2Sleep

ACTIVE COMPARATOR

Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

Behavioral: Care2Sleep

Sleep Education only

PLACEBO COMPARATOR

In-person, education on sleep, aging, and dementia but without specific or individualized recommendations

Behavioral: Sleep Education

Interventions

Care2Sleep BEHAVIORAL

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

In-Person Care2Sleep; Telehealth Care2Sleep

Sleep Education BEHAVIORAL

This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations

Sleep Education only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of California, San Diego: collaborator
• VA Greater Los Angeles Healthcare System: collaborator

Study Sites (3)

University of California San Diego

La Jolla, California, 92093, United States

RECRUITING

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, 91343, United States

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Yeonsu Song

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 11, 2022
• Study Start: November 9, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.

Locations

US (3)