Improving sleep health for Alzheimer's patients and their caregivers
A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers
This study is testing a new sleep program to see if it can help improve sleep quality and overall well-being for people with Alzheimer's and their caregivers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 672 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 3 sites (La Jolla, California and 2 other locations) |
| Trial ID | NCT05452031 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of the Care2Sleep intervention program on sleep quality, health status, and quality of life for both individuals with Alzheimer's disease and their caregivers. Participants will be randomly assigned to either in-person or telehealth versions of the Care2Sleep program or to an education control group. The intervention consists of five sessions, with assessments conducted immediately after the program and at a six-month follow-up to measure outcomes. The study spans five years and utilizes a behavioral intervention development model to guide its approach.
Who should consider this trial
Good fit: Ideal candidates include community-dwelling individuals aged over 60 with a diagnosis of Alzheimer's disease or related dementia who experience sleep problems and have an eligible caregiver.
Not a fit: Patients with untreated sleep disorders or severe medical conditions with a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall well-being for both Alzheimer's patients and their caregivers.
How similar studies have performed: Other studies have shown promise in improving sleep health in dementia populations, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Jolla, California and 2 other locations
- University of California San Diego — La Jolla, California, United States (Recruiting)
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
- Veterans Affairs Greater Los Angeles Healthcare System — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Yeonsu Song
- Email: ysong@sonnet.ucla.edu
- Phone: 310-983-3029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.