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

开发一款用于精确肺功能检测和哮喘诊断的一体式软可穿戴设备

• 批准号: 10726175
• 负责人: Yun Soung Kim
• 金额: $ 44.54万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-22 至 2025-09-21
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10726175
• 关键词: Acceleration; Accelerometer; Address; Adhesives; Affect; Algorithms; Anterior nares; Assessment tool; Asthma; Auscultation; Bite; Bluetooth; Cardiopulmonary; Caring; Cessation of life; Chest; Chronic; Clinical; Clip; Data; Data Analyses; Dedications; Detection; Development; Devices; Diagnosis; Diagnostic; Disease; Elastomers; Ensure; Environment; Foundations; Guidelines; Health care facility; Heterogeneity; Human; Human Resources; Individual; Laboratories; Lip structure; Location; Lung; Measurement; Measures; Methods; Monitor; Movement; Nature; Nose; Outpatients; Pathologic Processes; Patient-Focused Outcomes; Patients; Performance; Primary Care; Procedures; Process; Pulmonary Function Test/Forced Expiratory Volume 1; Pulmonary function tests; Quality of Care; Research; Resources; Respiratory Sounds; Risk; Role; Skin; Societies; Spirometry; Stethoscopes; Stress Tests; Symptoms; System; Technology; Test Result; Testing; Time; Training; United States; Visit; clinical decision-making; design; digital; effectiveness validation; elastomeric; experimental study; improved; microphone; miniaturize; mobile application; novel; overtreatment; portability; primary care setting; primary care visit; prototype; pulmonary function; recruit; seal; sensor; simulation; socioeconomics; sound; tool; usability; wearable device; wearable sensor technology; wireless

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.

项目摘要 广泛的异质性与不同的潜在病理过程和症状重叠 与广泛的疾病过程，使正确诊断哮喘困难，并有助于 哮喘治疗和护理的挑战。因此，确诊哮喘 涉及长期和复杂的诊断工作流程，包括多次测试和结果解释， 其过程仅可用于专用的肺部护理设施。相反，在大多数情况下， 有疑似哮喘症状的患者前往初级保健办公室进行初步评估，基于 办公室便携式肺活量计。然而，最近的研究表明，许多基于办公室的肺活量计 在"真实世界"环境中表现出可变的性能，在初级保健环境中产生混合结果。 鉴于肺量测定数据在哮喘诊断和治疗决策中的核心作用， 在初级诊所进行肺量测定可能会导致误诊或延误诊断。的 当前便携式肺活量计的主要缺点是它需要大量的用户关注和努力，例如 尽可能快和长时间地呼气，咬咬嘴并用嘴唇密封， 鼻孔用鼻夹，所有这些都有助于测试结果的高试验间变异性。研究 团队假设，一个新的测量工具，是更少地依赖于用户的努力和更容易 将导致肺功能的更一致和可靠的测量。所以在这 研究中，我们提出了以下具体目标，以开发一种新型的可穿戴传感器，可以附加 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部运动检测的柔软可穿戴设备。（二） 将声音数据和肺功能参数相关联，以开发肺功能估计算法。第三章 在患者临床环境中验证器械性能和可用性。我们将找出 传感器数据（肺/气道声音和胸部加速度测量）与标准肺功能之间的差异 参数由便携式肺活量计提供。通过这一点，将实现肺功能估计算法。 开发还将开发一个移动的应用程序，用于真实的处理传感器数据， 增强用户参与度，并确保即使在没有 人类教练在临床环境中使用传感器系统的可行性及其 作为一种可靠的肺功能评估工具的性能将通过患者访问医生的 肺部问题办公室这项研究的成功完成将导致开发一个新的 肺功能评估方法，需要较少的用户努力，比肺活量测定法更可靠 在初级保健机构进行。初级保健办公室肺功能评估方法的进展 将提高哮喘诊断、护理的准确性，并最终改善患者的预后。