Development of an all-in-one soft wearable device for accurate lung function detection and asthma diagnosis

项目总结 具有重叠的不同潜在病理过程和症状的广泛异质性 广泛的疾病过程使正确诊断哮喘变得困难，并导致 哮喘治疗和护理方面的挑战。因此，确认一个人的哮喘诊断 涉及涉及多个测试和结果解释的漫长而复杂的诊断工作流程， 这一过程只适用于专门的肺部护理机构。相反，对于大多数情况， 怀疑有哮喘症状的患者到初级保健办公室进行初步评估，根据 基于办公室的便携式肺活量计。然而，最近的研究表明，许多办公室用的肺活量计 在“现实世界”环境中表现出不同的表现，在初级保健环境中产生了不同的结果。 考虑到肺活量测量数据在哮喘诊断和治疗决策中的核心作用，次优 在初级办公室进行肺活量测定可能会导致误诊或延误诊断。这个 目前便携式肺活量计的主要缺点是需要广泛的用户关注和努力，例如 以尽可能快的速度和尽可能长的时间呼气，咬住牙套，用嘴唇封住它，并堵塞 鼻孔和鼻夹，所有这些都有助于测试结果具有很高的试验间变异性。这项研究 团队假设一种新的测量工具，它对用户的努力的依赖程度要低得多，而且更容易 使用将导致更一致和可靠的肺功能测量。因此，在这个 通过研究，我们提出了以下具体目标，以开发一种新型的可连接的可穿戴传感器 以生成与标准肺功能参数(FVC、FEV1和 PEF)：1)开发一种用于高保真听诊和胸动检测的软可穿戴设备。2) 将声音数据和肺功能参数相关联，以开发肺功能估计算法。3) 在临床环境中与患者一起验证设备的性能和可用性。我们将确定其中的关联 传感器数据(肺/呼吸道声音和胸腔加速度计)与标准肺功能之间的关系 便携式肺活量计提供的参数。通过这一点，肺功能估计算法将 发展起来的。还将开发一个实时处理传感器数据的移动应用程序，以 增强用户参与度，并确保即使在没有 人类教练。传感器系统在临床环境中使用的可行性以及他们的 作为一种可靠的肺功能评估工具的性能将在去看医生的患者身上得到验证 肺部问题办公室。这项研究的成功完成将导致开发一种新的 一种比肺活量测定法更可靠、更省力的肺功能评估方法 在初级保健环境中执行。初级保健办公室肺功能评估方法的研究进展 将提高哮喘诊断、护理的准确性，并最终提高患者预后。

PROJECT SUMMARY The extensive heterogeneity with differing underlying pathological processes and symptoms that overlap with a wide range of disease processes make correct diagnosis of asthma difficult and contribute to the challenges in treatment and care of asthma. Consequently, confirming one’s diagnosis of asthma involves a long and sophisticated diagnostic workflow involving multiple tests and interpretation of results, the process of which is available only to dedicated pulmonary care facilities. Instead, for majority of cases, patients with symptoms suspected of asthma visit primary care offices for initial assessment based on office-based portable spirometers. However, recent studies show that many office-based spirometers showed variable performance in “real-world” settings and produced mixed results in primary care settings. Given the central role of spirometry data in the diagnosis of asthma and treatment decision, suboptimal performance of spirometry in primary offices might contribute to misdiagnosis or delayed diagnosis. The main drawback of current portable spirometers is it requires extensive user focus and effort, such as expiring as quickly and long as possible, biting the mouthpiece and sealing it with the lips, and blocking the nostrils with a nose clip, all contributing to test results with high inter-trial variability. The research team hypothesizes that a new measurement tool that is much less dependent on user’s effort and easier to use will result in the more consistent and reliable measurement of lung functions. Therefore, in this study, we propose the following specific aims to develop a novel wearable sensor that can be attached to the user’s body to generate metrics comparable to standard lung function parameters (FVC, FEV1, and PEF): 1) Develop a soft wearable device for high-fidelity auscultation and chest movement detection. 2) Correlate sound data and lung function parameters to develop a lung function estimation algorithm. 3) Validate device performance and usability in a clinical setting with patients. We will identify the correlation between the sensor data (lung/airway sounds and chest accelerometry) and standard lung function parameters provided by a portable spirometer. Through this, a lung function estimation algorithm will be developed. A mobile application that processes the sensor data in real time will also be developed to enhance user engagement and to ensure each maneuver is performed correctly even in the absence of human coaching. Feasibility to use the sensor system in a clinical environment as well as their performance as a reliable lung function assessment tool will be validated with patients visiting a doctor’s office for pulmonary issues. The successful completion of this study will lead to the development of a new lung function assessment method that requires less user effort and is more reliable than spirometry performed in primary care settings. Advances in the mean to assess lung functions in primary care offices will improve the accuracy of asthma diagnosis, care, and ultimately patient outcome.