SBIR Phase II: Medical Device for Monitoring Respiratory Disease

该奖项全部或部分由《2021年美国救援计划法案》（公法117-2）资助。这个小企业创新研究（SBIR）二期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系统疾病，包括哮喘、慢性阻塞性肺病、慢性咳嗽和支气管扩张等疾病。慢性阻塞性肺病是美国和全球第三大致命疾病。由于这些疾病的流行和影响，每年投入86亿美元用于呼吸系统临床试验。目前，在呼吸治疗研究和药物临床试验中，受试者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每日波动的解决方案使用起来很麻烦，而且往往产生不可靠的数据，对得出可重复的结论帮助不大。此外，这些目前的解决方案大大增加了呼吸治疗临床试验的成本。该SBIR项目旨在通过生产一种可穿戴设备来解决这些挑战，该设备可以被动捕获准确的远程数据，这对于解锁呼吸保健领域的科学发现至关重要。该项目满足了一种可靠、低成本、低成本的方法来测量临床试验参与者呼吸体征的日常波动的迫切需求。拟议的小企业创新研究（SBIR）第二期项目采用先进的边缘计算来解决客观监测呼吸体征方面的挑战。所提出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，使其能够长期监测呼吸体征，包括咳嗽和喘息。所得到的模拟技术也可用于实现其他类型的最先进的医疗可穿戴设备。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值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.