NCT05452031 · RECRUITING
A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
This trial tests a behavioral sleep program called Care2Sleep against a sleep education control, for pairs of Alzheimer's patients and their live-in caregivers. Both in-person and telehealth versions are being compared. Researchers are measuring sleep quality, health, quality of life, and inflammation over six months. This is a Phase NA behavioral trial — it is evaluating real-world efficacy of a non-drug approach, not testing a medication.
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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-03-26