This research project will develop and implement a motivational interviewing and electronic messaging intervention to address obstructive sleep apnea (OSA), positive airway pressure (PAP) adherence, and risk of Alzheimer's disease and related dementias in American Indians. The project will work with American Indian Elders, aged 50 years and older, from three Northern Plains Reservations and surrounding communities. A total of 300 American Indian elders with a confirmed OSA diagnosis and prescribed PAP therapy will be randomized to receive usual care consisting of PAP therapy alone (control condition) or usual care plus the culturally informed CATNAP MI component (intervention condition).
The investigators will develop a multilevel 9-month culturally informed motivational interviewing and electronic messaging intervention- "Cognition After Obstructive Sleep Apnea (OSA) Among Native American People" (CATNAP) to: 1) provide participants with Motivational Interviewing sessions to address obstructive sleep apnea (OSA), positive airway pressure (PAP) adherence, and risk of Alzheimer's disease and related dementias (ADRD) in American Indians and 2) provide participants with electronic messaging to support PAP adherence among American Indian elders, aged 50 years and older. This study will explore the relationship between OSA and cognitive function and evaluate OSA as a mechanism for the strong association between sleep disorders and Alzheimer's disease and related dementias (ADRD). CATNAP will be implemented as a randomized controlled trial at 4 community sites serving American Indians in the Northern Plains. A total of 300 American Indian elders, aged 50 years and older, with a confirmed OSA diagnosis and prescribed PAP therapy will be randomized to receive usual care consisting of PAP therapy alone (control condition) or usual care plus the culturally informed CATNAP component (intervention condition). The primary outcome is PAP adherence and secondary outcome cognitive function. The study will partner with Missouri Breaks Industries Research Inc., and Missouri Breaks Durable Medical Equipment to monitor participants PAP use, which is uploaded automatically to the cloud. Outcomes will be measured at baseline, 3-months, and 9-months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Three motivational interviewing (MI) sessions will be facilitated by trained MI staff and will focus on improving participants' knowledge about their OSA diagnosis, understanding of sleep health, and increasing PAP use. Sessions will also provide information about health benefits associated with good sleep and will help participants create an action plan regarding their PAP use and indicators of success, when appropriate. Electronic messaging will be standardized for frequency and content but personalized to participants' preferred mode of delivery. Messages will focus on PAP adherence or non-adherence.
Missouri Breaks Industries Research Inc
Eagle Butte, South Dakota, United States
RECRUITINGPositive Airway Pressure (PAP) minutes per night
Participant mask-on time data collected by the PAP equipment will be extracted as continuous minutes per night.
Time frame: 9 months
Nights of PAP use
Proportion of nights with 4+ hours of PAP use from PAP device
Time frame: 9 months
PAP adherence
Use of device for more than 240 minutes per night, on 21 or more days out of the past 30 days. From PAP device.
Time frame: 9-months
Montreal Cognitive Assessment total score
The Montreal Cognitive Assessment is a widely used self-report instrument to screen for cognitive impairment and probable dementia. It comprises 30 items and takes approximately 10 minutes to complete. The assessment generates a summary score with range of 0 to 30, with scores 25 and above indicating normal cognition. Scores of 19-25 are considered to indicate mild cognitive impairment, scores of 11-21 indicate probable dementia, and scores less than 10 indicating severe cognitive impairment and Alzheimer's disease.
Time frame: 9 months
Cognivue total score
The Cognivue Clarity device (Clarity: Comprehensive 10-Minute Cognitive Self Test \| Cognivue®) is a 10- to 15-minute patient-administered test that evaluates cognition in 6 domains: visuospatial, executive function, memory, naming/language, delayed recall, and abstraction. Study staff will be present to provide assistance in using the device, as needed. The device generates a summary score with scores 75 and above indicating normal cognitive function, 50-75 indicating mild cognitive impairment, and scores below 50 indicating severe cognitive impairment.
Time frame: 9 months
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