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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要慢性阻塞性肺病是全球第四大杀手，部分原因是一线药物未能早期发现疾病会导致不良结果和高医疗保健。远程听诊器*或“TS”是一种新技术，可以从其中捕获声学数据。普通手机可以对血流动力学和呼吸动力学进行稳健的分析。 TS 旨在用于初级保健，特别是远程医疗和预约前其目的是提醒初级保健医生进行体检的必要性。在这些情况下，没有其他类似的测试。选项。 TS有三个重要的创新，首先是临床使用创新，它带来了远程、对任何拥有智能手机的人进行即兴患者评估已得到客户发现的验证。此外，工作流程和报销策略都与商业成功相一致。 FDA 指南表明了机构审批的可行性。其次是 TS 的新颖方法。制作 AI 算法时使用 OEM 手机麦克风捕获的声学数据。描述器官血流动力学和呼吸动力学的严格的、基于物理的特征。然后使用特征或自变量创建二元分类模型通过逻辑回归，TS 永远不必使用神经网络或过度拟合策略引发了对数据强度、模型稳定性、监管的担忧第三个创新是，依靠被动。声学数据，TS通过直接观察器官动态而不是对器官功能进行分类 TS 使用了许多物理学思想，这些思想直到相当时期才可用。最近，通过依靠动力学，TS 提供了一种最终可能实现的强制通风的新颖方法。即使在 PFT 实验室中，也有助于我们了解呼吸状况。这将是第三次大规模人体研究，展示了有氧运动的分类 - 它遵循一项已发表的关于新冠病毒检测的研究，并将很快发布。即将发表关于 TS 再现射血超声心动图评估能力的研究听诊器记录的分析表明慢性阻塞性肺病的诊断将依赖于。右心侧血流动力学和低频肺呼吸动力学的组合 A。大量研究证实了移动电话作为一种工具的使用能够检测和诊断慢性阻塞性肺病的听诊设备。本研究的目的是开发、评估和测试一种算法，允许普通移动设备我们的假设是，TS 技术可以通过匹配来检测 COPD。电话录音后由医生做出诊断。考虑黄金标准测试，模型的性能将通过使用进行评估。常见的统计方法，例如受试者工作曲线下面积 AUC，根据招募的情况，该研究将有 3 个里程碑。分别为 30、60 和 100 名患者。我们的方法基于从分配到医院 PFT 实验室的患者中招募，以便录音和黄金标准测试是同时进行的。一系列人才，包括 TS 的发明者、肺病学专业知识、研究主任运行测试、统计专业知识和项目的医院的急诊医学管理。 * 远程听诊器或“TS”是 Fleming Scientific 开发的正在申请专利的技术。