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New treatment option for Sleep
Official title A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
ClinicalTrials.gov ID: NCT05452031
What this study is testing
- What it's testing
- 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).
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join 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.
See the full eligibility 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 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...
- Pittsburgh Sleep Quality Index (PSQI) total score \>5
- Montreal Cognitive Assessment (MoCA) ≥23
- Can communicate in English
- 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 study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Los Angeles, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.