Wearable, Always-on Stethoscope for Early Detection of Asthma Attack

用于早期检测哮喘发作的可穿戴、始终开启的听诊器

• 批准号: 10501924
• 负责人: EUN SOK KIM
• 金额: $ 73.25万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10501924
• 关键词: Acoustics; Adolescent; Age; Air Movements; Algorithms; Allergens; Ambulatory Monitoring; Asthma; Behavioral; Breathing; Caregivers; Caring; Cellular Phone; Cessation of life; Characteristics; Chest; Child; Childhood Asthma; Classification; Clinical; Clinical Management; Consensus; Consumption; Coughing; Detection; Development; Device Designs; Device or Instrument Development; Devices; Diagnosis; Ear; Early Diagnosis; Electronics; Elements; Emergency Situation; Event; Exercise; Exhalation; Exposure to; Failure; Family member; Frequencies; Goals; Guidelines; Home; Hospitalization; Human; Individual; Infant; Inhalation; Intellectual functioning disability; Internet; Lung; Measurable; Measures; Medical; Microfabrication; Monitor; Morbidity - disease rate; Nature; Outcome; Parents; Patients; Pattern; Pattern Recognition; Physiological; Physiology; Population; Process; Provider; Pulmonary function tests; Recording of previous events; Reporting; Research; Respiratory Diaphragm; Respiratory Function Tests; Respiratory Signs and Symptoms; Respiratory Sounds; Self Management; Signs and Symptoms; Sleep; Stethoscopes; Symptoms; Testing; Time; United States; United States National Institutes of Health; Visit; Wheezing; accurate diagnosis; age group; airway obstruction; algorithm development; asthma exacerbation; asthmatic; asthmatic patient; base; classification algorithm; clinically relevant; diagnostic accuracy; diagnostic criteria; diagnostic value; improved; microphone; novel; pediatric patients; performance tests; portability; pressure; prototype; pulmonary function; rate of change; response; signal processing; sound; sound frequency; tool; wireless

ABSTRACT This research aims to develop and test a wearable, always-on stethoscope to provide a solution to the unmet need for the quantification of respiratory symptoms. Such a device is necessary for the accurate diagnosis of asthma and assessment of asthma control in 6.8 million infants, young children and other populations with intellectual disability who are unable to report their respiratory symptoms or perform lung function testing in the United States. With accurate diagnosis and assessment of control, appropriate asthma therapy can be initiated without delays to minimize adverse asthma outcomes. The key elements needed in the proposed wearable stethoscope (i.e., a wireless stethoscope without a bulky acoustic coupler) are (1) resonant microphone array with unprecedented sound detectability over 100 – 800 Hz and (2) ultra-low power signal processing. We propose to develop a bank of acoustically-filtering microphones that are based on a high Q (quality factor) resonance of a microphone diaphragm, for accurate detection of abnormal lung sounds. A bank of Q-filtered and Q-enhanced microphones is proposed so that (1) feature-extracting filters may be avoided and (2) extremely small lung sounds can be detected from the chest without an acoustic coupler. Lung sounds are very difficult to detect from the chest without a bulky acoustic coupler, as the sound pressure level (SPL) is only 22 – 30 dB SPL, in free space, over a frequency range of 100 – 800 Hz. This kind of SPL cannot be accurately detected by a commercial miniature microphone. Thus, we will develop and use an array of 8 resonant microphones with Q of 40 – 60 (fabricated with a microfabrication process) to detect lung sounds down to 22 dB SPL, 4 dB lower than the lowest sound a human ear can detect, and to automatically segment the sound’s frequency components into 8 different narrowly-band-passed frequency regions over 100 – 800 Hz. We hypothesize that continuous ambulatory monitoring of lung sounds for acoustic characteristics of asthma will improve the diagnostic accuracy and treatment in pediatric asthma patients. Currently, asthma is diagnosed in small children primarily through caregiver history and brief in-office exam as direct patient history and respiratory function testing are not available for these young patients. The proposed device is entirely novel as currently there is no device capable of providing round-the-clock monitoring for signs of asthma. While conventional microphones can detect cough and overt wheezing, their utility is limited by insufficient sensitivity, and are not amenable for continuous, ambulatory monitoring. The proposed resonant microphone array will be integrated with ultralow power electronics for a wearable stethoscope that continuously tracks lung sounds for the detection of asthma signs and symptoms such as cough and wheeze which may occur during exercise or sleep (when caregivers are not present) and may be misreported or ignored by young children. Wirelessly transmitted abnormal lung sounds will be accessed through the internet. The proposed stethoscope will provide an unprecedented means for those incapable of providing an accurate history or difficulty with self-management, such as pre-verbal children and individuals with intellectual disability, to avoid serious asthma morbidity. The device detects signs of uncontrolled asthma and notifies the parent, caregiver and medical professionals through the internet. In doing so, we may improve the management of asthma patients through more accurate tracking of environmental and behavioral triggers which can be used to improve management. To test the potential clinical utility of the wearable stethoscope, we will first record lung sounds with conventional electronic stethoscopes from pediatric patients, and annotate them as “normal,” “wheeze,” “cough,” etc. by a panel of expert reviewers. The annotated sounds will be subjected to spectral filtering chosen to parallel the frequency response of the proposed resonant microphone array. A pattern recognition algorithm will be applied to these sound files and be used to determine the recognition accuracy of the wearable stethoscopes. Four sets of the wearable stethoscopes will be delivered at the 18th, 30th, 42nd and 54th month of the research period, and will be used to record lung sounds and test automatic classification accuracy, which will be compared to patients diagnosed with well- or poorly-controlled asthma as determined by consensus diagnostic criteria. Finally, the wearable stethoscopes will be tested in ambulatory asthmatic pediatric patients continuously over a 30 day period, for the predictive ability of the wearable stethoscope in detecting asthma attacks.

抽象的 这项研究旨在开发和测试可穿戴的，始终在听诊器中，以提供解决方案 未满足的呼吸症状数量。这样的设备对于准确的诊断需要 哮喘和680万婴儿，幼儿和其他人群的哮喘控制评估 智力残疾，他们无法报告其呼吸道症状或进行肺功能测试 美国。通过准确的诊断和对照评估，可以开始适当的哮喘治疗 没有延迟以最大程度地减少广告哮喘的结果。拟议可穿戴设备所需的关键要素 听诊器（即，没有笨重的声学耦合器的无线听诊器）是（1）共振麦克风阵列 超过100 - 800 Hz和（2）超低功率信号处理的前所未有的声音可检测性。我们建议 开发基于高Q（质量因子）共鸣的声学过滤麦克风 一个麦克风拨号，可准确检测异常的肺部声音。一堆Q过滤和Q增强的 提出了麦克风，以便（1）可以避免使用特征提取的过滤器，并且（2）极小的肺 可以从胸部检测到声音，而无需声音耦合器。 没有笨重的声学耦合器，很难从胸部发现肺部声音，因为声音 压力水平（SPL）仅在100 - 800 Hz的频率范围内，在自由空间中仅为22 - 30 dB SPL。这种 商业微型麦克风无法准确检测到SPL的。那，我们将开发和使用 Q 40 - 60（用微分联过程制造）的8个谐振麦克风的阵列以检测肺 听起来降至22 dB SPL，比人耳可以检测到的最低声音低4 dB，并且自动发出 将声音的频率组件分为8个不同的狭窄频段频率区域超过100个 - 800 Hz。 我们假设对肺部声音的连续卧床监测是为了证明 哮喘将提高小儿哮喘患者的诊断准确性和治疗。目前，哮喘是 通过护理人员历史诊断为小孩的小孩，并简短的办公室考试作为直接患者病史 这些年轻患者无法获得呼吸功能测试。提出的设备完全是新颖的 由于目前尚无设备能够为哮喘的迹象提供全天候监视。尽管 传统的麦克风可以检测到咳嗽和明显的旋转，它们的效用受敏感性不足的限制， 并且不适合进行持续的门诊监测。 拟议的谐振麦克风阵列将与可穿戴 听诊器连续跟踪肺部声音以检测哮喘体征和符号，例如咳嗽 和锻炼或睡眠期间可能发生的方向（当不存在护理人员时），可能是 被幼儿报告或忽略了。通过无线传播异常肺部声音将通过 互联网。拟议的听诊器将为无法提供的人提供前所未有的手段 自我管理的准确历史或困难，例如言语前儿童和个人 智力残疾，以避免严重的哮喘发病率。该设备检测到不受控制的哮喘的迹象和 通过互联网通知父母，照顾者和医疗专业人员。这样，我们可能会改善 通过更准确的环境和行为触发因素来管理哮喘患者 可用于改善管理。 为了测试可穿戴听诊器的潜在临床实用性，我们将首先记录肺部声音 小儿患者的常规电子听诊器，并将其注释为“正常”，“喘息”，“咳嗽”， 由专家审稿人小组组成的。带注释的声音将经过光谱过滤与平行的光谱过滤 提出的共振麦克风阵列的频率响应。模式识别算法将是 应用于这些声音文件，并用于确定可穿戴听诊器的识别精度。 研究的四套可穿戴听诊器将在研究的第18、30、42和54个月份交付 期间，将用于记录肺部声音和测试自动分类精度，将进行比较 通过共识诊断标准确定的诊断患有诊断患有良好或控制良好的哮喘的患者。 最后，可穿戴的听诊器将在卧床性哮喘患者中进行测试 30天，可穿戴听诊器在检测哮喘发作方面具有预测能力。