R01AG075007

Personalized OSA Treatment and Effects on AD Biomarkers and Cognition Among Blacks - Project Summary

Evidence shows increased tau and amyloid-β burden among patients with obstructive sleep apnea (OSA). Impairment in memory, executive function, attention, and vigilance is also common among those patients. Fortunately, OSA treatment can normalize these biomarkers of Alzheimer's disease (AD) and improve cognitive function. Treatment can also reduce systemic inflammation and improve insulin sensitivity, blood pressure, and serum lipids and lipoproteins.

Notwithstanding such compelling data, little is known about the impact of OSA treatment among Blacks, a group shouldering a disproportionate burden of OSA and AD. Failure to benefit from these medical advances is due in part to a dearth of data explaining poor access to adequate OSA care, limiting our ability to implement health policies guiding aggressive OSA control among Blacks.

We propose an RCT to assess the effectiveness of our innovative personalized OSA treatment adherence model in enhancing adherence to OSA treatment among Blacks. We will implement an effective and scalable intervention to ascertain effects of OSA treatment on AD biomarkers and cognitive function as well as patient-centered outcomes.

First, we will leverage a stakeholder-endorsed, web-based sleep education platform (TASHE) we developed, featuring journeys of Black patients with OSA. Second, we will use a personalized approach for delivering video messages (OSA content & coaching advice) to increase OSA treatment self-efficacy. Messages will be personalized based on patients' idiosyncratic profile to nudge and navigate them in their preferred OSA care pathway.

Profiles will integrate patients' baseline data (e.g., demographic, medical, health literacy, motivation, readiness to change) and the emergent barriers gleaned from responses to ecological momentary assessment. Coaching messages about strategies to overcome system-level barriers impeding successful navigation of the OSA care pathway will be delivered using motivational enhancement.

Newly diagnosed Blacks (N=330, 60-85 years) will be randomly exposed to either the personalized or standard OSA messages (e.g., AASM & NSF). We will capture adherence data via telemetry, enabling real-time application of data-driven decision rules to optimize message delivery. We will ascertain biomarker and cognitive outcomes at baseline and at 6 months post-enrollment.

The study team will:
1) Assess the comparative effectiveness of the personalized, web-based intervention in increasing adherence to OSA treatment with positive airway pressure among newly diagnosed Blacks;
2) Determine whether OSA treatment improves a) molecular AD biomarkers (homocysteine, neurofilament light, glial fibrillary acidic protein, tau, and amyloid-β) and b) cognitive function (attention, language, memory, and executive function); and
3) Determine whether OSA treatment improves patients' health-related quality of life, daytime functioning, and sleep quality.

We expect the personalized OSA treatment adherence model (PRAISE) will have a significant impact on OSA treatment adherence, leading to improved OSA-related clinical and patient-centered outcomes.

University Of Miami

NOT APPLICABLE

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Miami, Florida 331362107 United States

Single Zip Code

Research on Current Topics in Alzheimer's Disease and Its Related Dementias (R01 Clinical Trial Optional) (PAR-19-070)

Amendment Since initial award the End Date has been extended from 05/31/27 to 05/31/28 and the total obligations have increased 285% from $786,803 to $3,032,871.