A breakthrough mobile phone technology that aids in early detection of COPD

突破性手机技术有助于早期发现慢性阻塞性肺病

• 批准号: 10760409
• 负责人: Martin Richard Huecker
• 金额: $ 29.94万
• 依托单位: TELE-STETHOSCOPE INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10760409
• 关键词: Acoustics; Address; Air; Algorithms; Area; Auscultation; Blood; COVID detection; COVID-19 detection; Cardiopulmonary; Cells; Cellular Phone; Chronic Obstructive Pulmonary Disease; Classification; Clinical; Code; Data; Development; Devices; Diagnosis; Diagnostic; Disease; EFRAC; Early Diagnosis; Echocardiography; Economics; Emergency Medicine; Evaluation; Failure; Frequencies; Funding; Future; Geography; Goals; Grant; Health Care Costs; Heart; Hospitals; Human; Image; Institutional Review Boards; International; Legal; Legal patent; Logistic Regressions; Lung; Lung Capacity; Machine Learning; Maps; Medicine; Modeling; Observational Study; Office Visits; Organ; Outcome; Patient Recruitments; Patients; Performance; Phase; Physical Examination; Physicians; Physics; Population; Primary Care; Primary Care Physician; Process; Protocols documentation; Provider; Publishing; Pulmonary Function Test/Forced Expiratory Volume 1; Pulmonology; Race; Research; Research Support; Running; Schedule; Sensitivity and Specificity; Series; Shapes; Side; Site; Specificity; Spirometry; Stethoscopes; Talents; Technology; Telephone; Testing; Universities; accurate diagnosis; accurate diagnostics; artificial intelligence algorithm; clinical practice; commercial launch; cost; demographics; diagnostic platform; diagnostic strategy; hemodynamics; human error; human study; improved; improved outcome; infrastructure development; innovation; interest; member; microphone; neural network; new technology; novel; novel strategies; power analysis; recruit; remote grading; respiratory; screening; success; technology development; telehealth; text searching

Project Summary / Abstract COPD is the fourth leading global killer, in part, because of the failure of frontline medicine to detect the disease. Poor early detection leads to unfavorable outcomes and high healthcare costs. Tele-stethoscope* or “TS” is novel technology that allows acoustic data captured from ordinary mobile phones to perform robust analysis of hemodynamics and pneumodynamics. TS is intended to be used in primary care particularly in Tele-health and before scheduled physical examination. Its purpose is to alert primary care physicians to the need for physical examination and possibly referral. In these situations, there are no other comparable testing options. TS has three important innovations. First, is a clinical use innovation which brings remote, impromptu patient evaluation to anyone with a smartphone. Customer discovery has validated both a workflow and reimbursement strategy consistent with commercial success. Further, FDA guidance suggests viability of agency clearance. Second is TS’s novel approach to making AI algorithms. TS uses acoustic data, captured by OEM phone microphones, into rigorous, physics-based features that describe organ hemodynamics and pneumodynamics. The features or independent variables are then used to create binary classification models with logistic regression. By relying on physics, TS never has to use neural networks or overfitting strategies that have raised concerns about data intensity, model stability, regulatory transparency and unknown reliability. The third innovation is that, by relying on passive acoustic data, TS classifies organ function by observing organ dynamics directly rather than from forced air capacity. TS uses many ideas from physics that were not available until fairly recently. By relying on dynamics, TS offers a novel approach to forced air that may eventually be additive to our understanding of respiratory conditions even in PFT labs. This will be the third large scale human study that demonstrates classification of cardio - pulmonary functionality. It follows a published study on COVID detection as well as soon to be published study on the ability of TS to reproduce echocardiogram estimates of ejection fraction. Analysis of stethoscope recordings suggests that the COPD diagnostic will rely on a combination of right heart side hemodynamics and low frequency lung pneumodynamics. A significant body of research is presented which validates the use of mobile phones as an auscultation device with the ability to detect and diagnosis COPD. The Aim of this study is to develop, evaluate, and test an algorithm that allows ordinary mobile phones to detect COPD. Our hypothesis is that TS technology can detect COPD by matching phone acoustic recordings to diagnosis. Diagnosis will be determined by a physician after considering gold standard testing. Performance of the models will be evaluated by using common statistical approaches such as area under the receiver operating curve AUC, sensitivity, specificity, accuracy. The research will have 3 milestones based on recruitment of 30, 60 and 100 patients respectively. Our approach is based on recruitment from patients assigned to a hospital PFT lab so that recordings and gold standard testing are done concurrently. Our team consists of a broad range of talent including the inventor of TS, pulmonology expertise, the research director of emergency medicine for the hospital running the tests, statistical expertise, and project management. * Tele-stethoscope or "TS" is patent pending technology developed by Fleming Scientific.

项目摘要 /摘要 COPD是第四位领先的全球杀手，部分原因是一线医学未能 检测疾病。早期发现不良导致不利的结果和高度医疗保健 费用。远程测试仪*或“ TS”是新技术，允许从中捕获的声学数据 普通手机对血液动力学和肺气动力学进行鲁棒分析。 TS旨在用于初级保健，尤其是在电信中和计划之前 体格检查。它的目的是提醒初级保健医生需要身体上的需要 检查和可能的推荐。在这些情况下，没有其他可比的测试 选项。 TS有三个重要的创新。首先，是一种临床用途创新，使远程 对使用智能手机的任何人的即兴患者评估。客户发现已验证 工作流程和报销策略都与商业成功一致。更远， FDA指导表明代理清算的可行性。第二是TS的新方法 制作AI算法。 TS使用OEM电话麦克风捕获的声学数据进入 严格的，基于物理的特征，描述器官血液动力学和肺气动力学。 然后使用功能或自变量来创建二进制分类模型 带有逻辑回归。通过依靠物理学，TS不必使用神经网络或 过度拟合的策略引起了人们对数据强度，模型稳定性，调节性的关注 透明度和未知可靠性。第三个创新是，依靠被动 声学数据，TS类器官的功能通过直接观察器官动力学而不是 从强迫空气容量。 TS使用了许多物理学的想法，直到公平 最近。通过依靠动态，TS提供了一种新颖的方法来强制空气，有时可能 即使在PFT实验室中，也可以添加我们对呼吸条件的理解。 这将是第三项大规模的人类研究，证明了有氧运动的分类 - 肺功能。它遵循一项关于共同检测的已发表的研究，并立即 可以发表有关TS再现超声心动图估计的能力的研究 分数。听诊器记录的分析表明，COPD诊断将依靠 右心脏血流动力学和低频肺肺动脉动力学的结合。一个 提出了大量的研究机构，该研究证实了手机的使用 具有检测和诊断COPD的能力的听觉设备。 这项研究的目的是开发，评估和测试允许普通移动的算法 手机检测COPD。我们的假设是TS技术可以通过匹配来检测COPD 将声学录音发送给诊断。诊断将由物理后的确定 考虑黄金标准测试。模型的性能将通过使用 常见的统计方法，例如接收器操作曲线AUC下的面积， 灵敏度，特异性，准确性。这项研究将根据招聘的3个里程碑 分别为30、60和100名患者。 我们的方法是基于分配给医院PFT实验室的患者的招聘 记录和金标准测试是同时进行的。我们的团队包括一个广泛的 人才范围，包括TS清单，肺科专业知识，研究总监 医院的急诊医学运行测试，统计专业知识和项目 管理。 *远程测试仪或“ TS”是Fleming Scientific开发的申请专利技术。