SBIR-STTR Award

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will investigate the feasibility of novel wearable sensor techniques to provide a complete diagnostic assessment for obstructive sleep apnea (OSA) with a single wireless patch worn on the chest. An estimated 25-30 M adults in the United States have OSA, but 80% of OSA-positive patients are undiagnosed while the highest volume clinics can only conduct around 5,000 sleep tests annually. Low diagnosis rates result partly from the challenge of sleep clinics managing an inventory of expensive and complex home sleep testing devices. To date, all home sleep tests require patients to wear bulky sensors that attach to multiple (3-5) regions of their body via a network of wires, tubes, and probes. This project will explore novel, unobtrusive, cost-effective sensors to reliably detect apnea and hypopnea during sleep. The project outcomes will strengthen fundamental understanding of how physiological signals are altered during sleep apnea and how to reliably measure these signals using simple wearable patches.The proposed SBR Phase I project will advance the development of a sensor platform for a wireless device to diagnose obstructive sleep apnea. The project will explore the feasibility of new sensing modalities to provide sufficient diagnostic information with a single wireless patch. The innovation stems from: (1) use of novel cardiorespiratory sensing modalities and machine learning to determine respiratory events and arousals from disordered breathing, and (2) integration of multiple sensing modalities into a chest-worn patch to provide a complete assessment of sleep apnea severity according to established clinical guidelines. This project will: conduct functional tests of sensor modalities relative to the clinical standard wired technologies; identify digital signatures of disordered breathing using advanced digital signal processing techniques; and assess the diagnostic capability of the complete single patch sensor relative to the clinical gold standard sleep tests.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to help patients with cardiorespiratory conditions, including sleep apnea and cardiac arrhythmia. The project will develop a wearable sensor platform to simultaneously diagnose and monitor conditions. Multiple physiological measurements are collected by a comfortable, wireless sensor patch, resulting in a convenient remote monitoring clinical framework. Interfacing sensor data with an efficient cloud-based provider portal and automated algorithms will enable rapid screening of the 24 million undiagnosed sleep apnea patients in the United States. The proposed innovation will also provide insight into the practical clinical benefits and efficiencies to be gained by bundling multiple comorbid or otherwise related diagnostic pathways into a single workflow, such as reducing time to treatment for comorbid atrial fibrillation. This remote monitoring bundle concept represents the only all-in-one device capable of servicing multiple highly pervasive health challenges in a method unobtrusive and user-friendly for both the patient and the provider - particularly for telemedicine applications made more urgent by the global pandemic.This Small Business Innovation Research (SBIR) Phase II project aims to develop a simple, accurate, cloud-connected wearable patch and collect clinical comparison data to develop automated, low-power algorithms to simultaneously detect sleep-disordered breathing, sleep stages, and cardiac arrhythmias. The project integrates materials science, mechanical engineering, and signal processing approaches to detect critical physiological signals from the torso, including oxygen saturation and several hemodynamic metrics. The project will also conduct studies that offer early insights into the clinical benefits of bundled workflows across cardiac and sleep medicine specialties.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.