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: 10665806
• 负责人: EUN SOK KIM
• 金额: $ 69.53万
• 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/10665806
• 关键词: Acoustics; Adolescent; Age; Air Movements; Algorithms; Allergens; Ambulatory Monitoring; Asthma; Behavioral; Breathing; Caregivers; Caring; Cellular Phone; Cessation of life; Characteristics; Charge; Chest; Child; Childhood Asthma; Classification; Clinical; Clinical Management; Consensus; 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; Notification; 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; automated segmentation; battery recharging; classification algorithm; clinically relevant; diagnostic accuracy; diagnostic criteria; diagnostic value; improved; member; microphone; novel; pediatric patients; performance tests; portability; power consumption; pressure; prototype; pulmonary function; response; signal processing; sound; sound frequency; tool; verbal; wireless; wireless communication; wireless transmission

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一种可穿戴、始终开启的听诊器，为以下问题提供解决方案： 呼吸道症状量化的需求尚未得到满足，这样的设备对于准确诊断是必要的。 对 680 万名婴儿、幼儿和其他患有哮喘的人群进行哮喘的诊断和哮喘控制评估 无法报告呼吸道症状或无法进行肺功能测试的智力障碍 美国。通过准确的诊断和控制评估，可以开始适当的哮喘治疗。 毫不拖延地最大限度地减少哮喘不良后果。拟议的可穿戴设备所需的关键要素。 听诊器（即没有笨重声耦合器的无线听诊器）是 (1) 谐振麦克风阵列 具有超过 100 – 800 Hz 的前所未有的声音检测能力和 (2) 超低功耗信号处理。 开发一系列基于高 Q（品质因数）谐振的声学过滤麦克风 麦克风隔膜，用于准确检测异常肺音 一组 Q 过滤和 Q 增强。 提出麦克风的目的是为了（1）可以避免特征提取滤波器以及（2）极小的肺 无需声耦合器即可从胸部检测声音。 如果没有笨重的声耦合器，很难从胸部检测到肺部声音，因为声音 在自由空间中，频率范围为 100 – 800 Hz 时，声压级 (SPL) 仅 22 – 30 dB SPL。 商用微型麦克风无法准确检测到 SPL。因此，我们将开发并使用一种。 8 个谐振麦克风阵列，Q 值为 40 – 60（采用微加工工艺制造），用于检测肺部 声音低至 22 dB SPL，比人耳可以检测到的最低声音低 4 dB，并自动 将声音的频率分量分割为 100 多个不同的 8 个窄带通频率区域 – 800 赫兹。 我们追求对肺音的声学特征进行连续动态监测 哮喘将提高儿童哮喘患者的诊断准确性和治疗效果。 主要通过护理人员病史和作为直接患者病史的简短诊室检查对幼儿进行诊断 这些年轻患者无法进行呼吸功能测试。所提出的设备是全新的。 目前还没有能够全天候监测哮喘症状的设备。 传统的麦克风可以检测咳嗽和明显的喘息，但其实用性因灵敏度不足而受到限制， 并且不适合连续的流动监测。 拟议的谐振麦克风阵列将与超低功耗电子器件集成，用于可穿戴设备 持续跟踪肺部声音以检测咳嗽等哮喘体征和症状的听诊器 以及运动或睡眠期间（当护理人员不在场时）可能发生的喘息，并且可能是 无线传输的异常肺部声音将被幼儿错误报告或忽视。 拟议的听诊器将为那些无法提供服务的人提供前所未有的手段。 准确的历史记录或自我管理方面的困难，例如语言前儿童和患有自我管理困难的人 智力障碍，以避免严重的哮喘发病。该设备可以检测不受控制的哮喘症状。 通过互联网通知家长、看护者和医疗专业人员，这样我们就可以改善情况。 通过更准确地跟踪环境和行为触发因素来管理哮喘患者 可用于改进管理。 为了测试可穿戴听诊器的潜在临床实用性，我们将首先记录肺音 儿科患者的传统电子听诊器，并将其注释为“正常”、“喘息”、“咳嗽” 等由专家评审小组进行注释的声音将受到选择为并行的频谱过滤。 所提出的谐振麦克风阵列的频率响应将是。 应用于这些声音文件并用于确定可穿戴听诊器的识别准确性。 四套可穿戴听诊器将在研究第18、30、42和54个月交付 期间，将用于记录肺音并测试自动分类的准确性，并将其进行比较 根据共识诊断标准诊断为哮喘控制良好或控制不良的患者。 最后，可穿戴听诊器将在门诊哮喘儿科患者中持续进行测试 30 天的时间段，用于评估可穿戴听诊器检测哮喘发作的预测能力。