Status:

RECRUITING

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

Lead Sponsor:

University of California, Los Angeles

Collaborating Sponsors:

University of California, San Diego

VA Greater Los Angeles Healthcare System

Conditions:

Sleep

Eligibility:

All Genders

18+ years

Phase:

NA

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 progr...

Eligibility Criteria

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.

Key Trial Info

Start Date :

November 9 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 31 2027

Estimated Enrollment :

672 Patients enrolled

Trial Details

Trial ID

NCT05452031

Start Date

November 9 2022

End Date

August 31 2027

Last Update

March 26 2025

Active Locations (3)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

1

University of California San Diego

La Jolla, California, United States, 92093

2

University of California Los Angeles

Los Angeles, California, United States, 90095

3

Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, United States, 91343