NCT05452031 · University of California, Los Angeles
A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
What this study is about
This is a randomly assigned controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the effectiveness of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only).
View original scientific description
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.
Interventions
BEHAVIORAL
Care2Sleep
A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.
BEHAVIORAL
Sleep Education
This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations
Primary outcome measures
Sleep efficiency-Actigraphy
Time frame: Change from Baseline Sleep Efficiency at 6 months
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
Pittsburgh Sleep Quality Index score
Time frame: Change from Baseline Pittsburgh Sleep Quality Index score at 6 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- La Jolla, California
- Los Angeles, California
Collaborators
University of California, San Diego, VA Greater Los Angeles Healthcare System
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations