Bilateral Acoustic Sensing and Automated Breathing Segmentation for Remote Monitoring of Patients with COPD: A Longitudinal Study

Bilateral Acoustic Sensing and Automated Breathing Segmentation for Remote Monitoring of Patients with COPD: A Longitudinal Study Abstract: This SBIR Fast-Track project complies with NIH NOSI number NOT-OD-21-100, focusing on a novel mobile health system for remote monitoring of chronic obstructive pulmonary disease (COPD) using a wearable multimodal sensor. COPD is the third leading cause of death globally, with over 3 million fatalities and an annual cost of $52 billion in the U.S. In partnership with the Johns Hopkins Clinical Research Network (JHCRN), this project aims to provide innovative technology to underserved patients in the Mid-Atlantic region. Aligning with the NIH's emphasis on improving patient adherence, the project centers on enhancing adherence to remote monitoring and early symptom recognition to reduce COPD readmissions and healthcare costs. COPD symptoms include dyspnea, coughing, and sputum production. The current 23% readmission rate poses a significant burden on the healthcare system. Early symptom detection can facilitate home treatment, reducing readmissions and costs. Standard lung function assessments require medical expertise and are not suited for continuous, remote monitoring. Early detection of deteriorating lung function enables timely intervention and management of COPD severity. This project extends our Intel award-winning, patented wireless WearME system to capture physiologic baselines and potential acute changes in COPD patients. WearME uses a body area sensor network with multimodal sensing capabilities, such as digital stethoscope, body kinematics, and electrocardiogram. We will explore our sensing modalities to capture bilateral biomarkers and changes in lung function, respiration period, and user activity. In Phase I, we will assess lung function and user respiration in real-time during activities of daily living (ADL), like walking and stair climbing, in an in-clinic cross-sectional study. The goal is to evaluate patients' physical function and ability to perform ADL for the Phase II longitudinal study. In Phase II, we will validate our WearME system through remote monitoring, usability, and adherence studies, associating changes in biomarkers with ADL. To ensure high adherence rates, strategies such as push notifications, patient engagement programs, and incentives will be implemented. For patients who do not own a suitable smartphone, we are prepared to provide a loaner device for the duration of their participation in the study. The revised proposal emphasizes the unique advantages of the WearME-Pro system over traditional hand-held spirometers. Unlike hand-held spirometers that provide only intermittent data, our wearable device provides a more comprehensive picture of a patient's respiratory health over time. The device also captures cough frequency, a known precursor to exacerbations. Such continuous monitoring enables healthcare providers to track changes in the patient's respiratory conditions and respond promptly to potential exacerbations. We have instituted regular meetings, specific task assignments, and clear communication protocols to ensure efficient collaboration among the team members. The results of this SBIR Fast-Track project will support FDA submission for 510(k) clearance and commercialization, leveraging partnerships with Johns Hopkins, TidalHealth, and Tower Health to market our solution through a prescription model. By addressing patient adherence, this project aims to significantly impact COPD management and promote better health outcomes for patients. 1