I-Corps: Translation Potential of a Medical Device for Early Detection of Sleep Apnea

这个I-Corps项目的更广泛的影响是基于开发一种筛选睡眠呼吸暂停的原型生物医学设备。睡眠呼吸暂停是诊断不足，由于缺乏成本效益和简单的工具来筛选睡眠呼吸暂停在家里，以及有限的设施进行诊断研究。这种原型筛查设备可能更具成本效益，更易于使用，同时允许在家中进行多夜测试，这比在指定设施进行单夜测试更准确。这种诊断设备可以产生早期风险数据，这可以允许根据疾病的严重程度将患者正确分类到睡眠实验室。这个I-Corps项目利用体验式学习加上对行业生态系统的第一手调查来评估该技术的翻译潜力。该解决方案是基于睡眠呼吸暂停早期检测工具的开发。由于其对心肺健康的广泛影响，有必要采用新的筛查方法来解决当前睡眠呼吸暂停诊断研究的缺点，包括等待时间长和产量相对较低。尽管自2010年以来，患者可以进行家庭睡眠测试，但80%的睡眠呼吸暂停病例仍未得到诊断。作为回应，这种算法增强的原型利用诸如氧气信号和人口统计学和人体测量数据等数据来预测家中睡眠呼吸暂停的严重程度。该原型设备有可能解决睡眠呼吸暂停诊断不足的问题，并改善患者的临床结果。该奖项反映了NSF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。

The broader impact of this I-Corps project is based on the development of a prototype biomedical device that screens for sleep apnea. Sleep apnea is under-diagnosed due to a lack of cost-effective and simple tools to screen for sleep apnea at home, as well as limited facilities to conduct diagnostic studies. This prototype screening device is potentially more cost-effective and easier to use, while allowing multiple-night testing at home, which is more accurate than single-night tests in designated facilities. This diagnostic device may yield early risk data, which could allow for proper triaging of patients to the sleep lab based on the severity of the disease. This I-Corps project utilizes experiential learning coupled with a first-hand investigation of the industry ecosystem to assess the translation potential of the technology. The solution is based on the development of a tool for the early detection of sleep apnea. Due to its wide-ranging impacts on cardiopulmonary health, novel screening methods that address the shortcomings of the current sleep apnea diagnostic studies, including long wait times and relatively low yield, are necessary. Though home sleep testing has been available for patients since 2010, 80% of sleep apnea cases remain undiagnosed. In response, this algorithm augmented prototype utilizes data such as oxygen signals and demographic and anthropometric data to predict the severity of sleep apnea at home. This prototype device has the potential to address the underdiagnosis of sleep apnea and improve clinical outcomes for patients.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.