SBIR Phase I: Single wearable patch for cost-effective, reliable, and accurate home sleep apnea testing

SBIR 第一阶段：单个可穿戴贴片，用于经济高效、可靠且准确的家庭睡眠呼吸暂停测试

• 批准号: 2016158
• 负责人: Brennan Torstrick
• 金额: $ 22.5万
• 依托单位: HUXLEY MEDICAL, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2021-05-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2016158&HistoricalAwards=false
• 关键词: SBIR; Phase; Single; wearable; patch

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.

该小企业创新研究 (SBIR) 第一阶段项目的更广泛影响/商业潜力将研究新型可穿戴传感器技术的可行性，通过佩戴在胸部的单个无线贴片为阻塞性睡眠呼吸暂停 (OSA) 提供完整的诊断评估。据估计，美国有 25-3000 万成年人患有 OSA，但 80% 的 OSA 阳性患者未被诊断出来，而最大的诊所每年只能进行约 5,000 次睡眠测试。诊断率低的部分原因是睡眠诊所在管理昂贵且复杂的家庭睡眠测试设备库存方面面临挑战。迄今为止，所有家庭睡眠测试都要求患者佩戴笨重的传感器，这些传感器通过电线、管子和探针网络连接到身体的多个（3-5）区域。该项目将探索新颖、不引人注目、经济高效的传感器，以可靠地检测睡眠期间的呼吸暂停和呼吸不足。该项目的成果将加强对睡眠呼吸暂停期间生理信号如何改变以及如何使用简单的可穿戴贴片可靠地测量这些信号的基本理解。拟议的 SBR 第一阶段项目将推动无线设备传感器平台的开发，以诊断阻塞性睡眠呼吸暂停。该项目将探索新传感方式的可行性，以通过单个无线贴片提供足够的诊断信息。该创新源于：(1) 使用新型心肺传感模式和机器学习来确定呼吸事件和呼吸紊乱引起的唤醒，以及 (2) 将多种传感模式集成到胸前佩戴的贴片中，以提供对睡眠呼吸暂停的完整评估根据既定的临床指南的严重程度。该项目将： 进行与临床标准有线技术相关的传感器模式的功能测试；使用先进的数字信号处理技术识别呼吸紊乱的数字特征；并评估完整的单贴片传感器相对于临床金标准睡眠测试的诊断能力。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力优点和更广泛的影响审查标准进行评估，被认为值得支持。