SBIR Phase II: Medical Device for Monitoring Respiratory Disease

该奖项的全部或部分资金来自《2021年美国救援计划法案》(公法117-2)。这个小型企业创新研究(SBIR)第二阶段项目的更广泛的影响/商业潜力是帮助开发新的和更好的呼吸疗法。超过10亿人患有慢性呼吸道疾病，包括哮喘、慢性阻塞性肺疾病(COPD)、慢性咳嗽和支气管扩张。慢性阻塞性肺病是美国和全球第三大致死性疾病。由于这些疾病的流行和影响，每年投资86亿美元用于呼吸道临床试验。目前，在呼吸疗法研究和药物临床试验中，参与者的咳嗽和喘息可以作为衡量药物疗效的主要或次要终点。目前用于捕捉咳嗽或呼吸的每日波动的解决方案使用起来很麻烦，而且经常产生不可靠的数据，对得出可重复性的结论帮助较小。此外，这些目前的解决方案大大增加了呼吸疗法临床试验的成本。该SBIR项目旨在通过生产一种可穿戴设备来应对这些挑战，该设备可以被动捕获准确的远程数据，这些数据对于解锁呼吸护理领域的科学发现至关重要。该项目迫切需要一种可靠、低成本、低成本的方法来测量临床试验参与者呼吸信号的日常波动。拟议的小型企业创新研究(SBIR)第二阶段项目采用先进的边缘计算来应对客观监测呼吸迹象方面的挑战。拟议的活动可能会在超低功耗生物医学可穿戴设备领域取得进展。特别是，将开发新的非线性模拟处理技术，使其能够对包括咳嗽和喘息在内的呼吸道体征进行长期监测。由此产生的模拟技术也可以用于实现其他类型的最先进的医疗可穿戴设备。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

This award is funded in whole or in part under the American Rescue Plan Act of 2021 (Public Law 117-2). The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II Project is to aid the development of new and better respiratory therapeutics. Over 1 billion individuals suffer from chronic respiratory diseases including conditions such as asthma, chronic obstructive pulmonary disease (COPD), chronic cough, and bronchiectasis. COPD is the third deadliest disease in the U.S. and globally. Due to the prevalence and impact of these diseases, $8.6 billion is invested in respiratory clinical trials annually. Currently, in respiratory therapy research and pharma clinical trials, participants’ coughing and wheezing can be a primary or secondary endpoint for measuring drug efficacy. Current solutions for capturing daily fluctuations in cough or respiration are burdensome to use and often produce unreliable data that is less helpful for drawing reproducible conclusions. Additionally, these current solutions add significantly to the cost of respiratory therapy clinical trials. This SBIR Project seeks to address these challenges by producing a wearable device that passively captures accurate, remote data that is essential to unlocking scientific discoveries in respiratory care. This project serves an urgent, unmet need for a reliable, low-effort, low-cost way to measure daily fluctuations in clinical trial participant respiratory signs.The proposed Small Business Innovation Research (SBIR) Phase II Project employs advanced edge computing to address challenges in objectively monitoring respiratory signs. The proposed activity may make advances in the field of ultra-low power biomedical wearable devices. In particular, new nonlinear analog processing techniques will be developed to make it feasible for long-term monitoring of respiratory signs, including coughing and wheezing. The resulting analog techniques may also be used to implement other types of state-of-the-art medical wearable devices.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.