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

Sleep Clinical Trial

Official title:

A Dyadic Approach to Improve Sleep and Well-Being Among Persons With Alzheimer's Disease and Their Caregivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05452031
• Other study ID #: 1R01AG076756-01
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2022
• Est. completion date: August 31, 2027

Study information

• Verified date: February 2024
• Source: University of California, Los Angeles
• Contact: Yeonsu Song
• Phone: 310-983-3029
• Email: ysong[@]sonnet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 672
• Est. completion date: August 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Sleep

Intervention

Behavioral:
• Care2Sleep
A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light exposure.
• Sleep Education
This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California
United States	University of California Los Angeles	Los Angeles	California
United States	Veterans Affairs Greater Los Angeles Healthcare System	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	University of California, San Diego, VA Greater Los Angeles Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep efficiency-Actigraphy	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	Change from Baseline Sleep Efficiency at 6 months
Primary	Pittsburgh Sleep Quality Index score	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.	Change from Baseline Pittsburgh Sleep Quality Index score at 6 months
Secondary	Total score of Revised Memory and Behavior Problem Checklist	Dementia-related problem behaviors among persons with dementia (reported by caregivers). Range from 0 to 96 with higher scores indicating more severe dementia-related behaviors.	Immediately AND 6 months after the last session of the intervention
Secondary	Total score of Quality of Life-Alzheimer's Disease Scale	Quality of life among persons with dementia reported by either caregivers or persons with dementia. Range from 4 to 52 with higher scores indicating better quality of life among persons with dementia	Immediately AND 6 months after the last session of the intervention
Secondary	Total score of Zarit Burden Interview	Perceived levels of caregiving burden. Range from 0 to 88 with higher scores indicating greater burden among caregivers	Immediately AND 6 months after the last session of the intervention
Secondary	Total score of Center for Epidemiological Study of Depression Scale	Perceived frequency of depressive symptoms during the past week. Ranges from 0 to 60 with higher scores indicating greater levels of depressive symptoms among caregivers	Immediately AND 6 months after the last session of the intervention
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) global health score	Self-reported physical and mental health scores among caregivers. A T-score of 50 represents the mean of the general population. Higher scores indicate better physical and mental health among caregivers	Immediately AND 6 months after the last session of the intervention
Secondary	Levels of inflammatory markers	Three key inflammatory markers including C-reactive protein, Tumor necrosis factor-alpha, Interleukin-6 will be collected among caregivers only	Immediately AND 6 months after the last session of the intervention