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

University of California, Los Angeles (UCLA)

Status: Enrolling

Conditions: Sleep

Treatments: Behavioral: Care2Sleep; Behavioral: Sleep Education

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05452031

1R01AG076756-01

Details and patient eligibility

About

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.

Enrollment: 672 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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672 participants in 3 patient groups, including a placebo group

In-Person Care2Sleep

Experimental group

Description:

In-person, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

Treatment:

Behavioral: Care2Sleep

Telehealth Care2Sleep

Active Comparator group

Description:

Telehealth, manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy

Treatment:

Behavioral: Care2Sleep

Sleep Education only

Placebo Comparator group

Description:

In-person, education on sleep, aging, and dementia but without specific or individualized recommendations

Treatment:

Behavioral: Sleep Education