Feelix @ Home: Testing and optimization of a smart stethoscope for home use to monitor changes in lung status of individuals with chronic conditions

项目摘要 该项目的目标是进一步开发现有的智能听诊器，以便能够 在家中监测患有哮喘的儿科患者以及患有COPD的成年人。肺部疾病 给医疗系统、个人和政府带来严重负担。世界卫生组织 (WHO)发现慢性阻塞性肺疾病(COPD)和下呼吸道感染(LRIS)排名 第三和第四是2016年的主要死因，每种死因每年都夺走了300万人的生命。LRIS已入账 占儿童死亡的14.9%，成为早产后婴儿死亡的主要原因。哮喘-a 像COPD一样，无法治愈的疾病-也是儿童的主要慢性病，据估计 全球有2.35亿人患有这种疾病，2015年有超过38万人死于这种疾病。哮喘 慢性阻塞性肺病去年分别给美国造成了约560亿美元和720亿美元的损失。负担 这些疾病和人群之间的健康差距在未来十年只会变得更糟， 由于人口老龄化和污染加剧，预计呼吸道疾病将增加155%， 而肺部专科医生预计将出现大量短缺，预计到2030年将下降7%。 我们认为，一种可供未经培训的患者在家中使用的长期监测解决方案，或者 患者家属，可以检测和监测患者呼吸道炎症的严重程度，提供 洞察症状恶化或改善的原因，推动量身定制的教育内容，并指导患者 在情况变得严重之前进行医疗跟踪，将增强慢性病患者的能力，同时还 减少去急诊科的次数和再住院率。我们发现有几个挑战 在考虑非传统临床环境中的长期听诊监测解决方案时存在：(1) 不可预测的环境噪音，(2)需要医疗专业知识来解释肺音，(3)主观性 分析；(4)听诊器使用和放置困难。研究小组开发了一种智能听诊器 它最初的目的是供社区卫生工作者在低资源国家使用，以区分 儿科患者之间的爆裂和喘息克服了许多这些挑战。这很聪明 听诊器通过包括(1)自适应噪声抑制 客观和主观证明在所有类型的噪声环境中优于传统或其他 电子听诊器，(2)车载分析算法，可以检测儿科患者的爆裂声和喘息 患者的精确度与专家相当，以及(3)统一的拾取器表面，可去除 需要准确放置设备才能获得准确的录音。 在这个项目中，我们将验证哮喘儿童的父母可以正确使用该设备，并 可以进行质量与医疗人员相似的准确记录 很专业。同时，我们将使用患者反馈来迭代设备和移动应用程序设计 以创造一个让患者在家中舒适使用的版本。一旦设备和应用程序 经过第一阶段的验证，我们计划直接进入第二阶段，设备将进入第二阶段 这将包括儿科患者父母首次进行的纵向研究，每天服用 他们家里的录音带。然后，这些数据将用于开发确定肺的算法 声音严肃性，具有可随时间跟踪和预测的指标。与这项临床研究同步进行 和算法的开发，将对成年COPD患者进行录音，以扩大其可用性 儿科以外的设备。

Project Summary The goal of this project is to further develop an existing smart stethoscope in order to be capable of monitoring pediatric patients at home who suffer from asthma as well as adults with COPD. Lung diseases impose a serious burden on healthcare systems, individuals and governments. The World Health Organization (WHO) found that chronic obstructive pulmonary disease (COPD) and lower respiratory infections (LRIs) ranked third and fourth as the leading causes of death in 2016, each claiming 3 million lives annually. LRIs accounted for 14.9% of pediatric deaths, making it the leading cause of infant mortality after pre-term birth. Asthma—a condition for which, like COPD, there is no cure—is also the leading chronic disease in children and an estimated 235 million people suffer from the disease worldwide, with over 380,000 deaths from the disease in 2015. Asthma and COPD costed the United States approximately $56 billion and $72 billion last year, respectively. The burden of these diseases and the health disparities across populations is only slated to get worse in the coming decade, as respiratory diseases are expected to increase by 155% due to an aging population and increased pollution, while there is expected to a large shortage of pulmonary specialists, with an expect 7% decline by 2030. We reasoned that a long-term monitoring solution that can be used in the home by untrained patients, or family members of patients, that could detect and monitor severity of airway inflammation in patients, provide insight into reasons for worsening or improved symptoms, push tailored educational content, and direct patients to medical follow before the situation becomes acute, would empower patients with chronic conditions while also reducing trips to emergency departments and readmission rates to hospitals. We find that several challenges exist when considering long term auscultatory monitoring solutions in non-traditional clinical settings: (1) unpredictable ambient noise, (2) the need for medical expertise to interpret lung sounds, (3) subjectivity in the analysis, and (4) difficulty using and placing the stethoscope. The research team developed a smart stethoscope that was originally intended for use in low-resource countries by community health workers to differentiate between pediatric patients with crackles and wheezes that overcomes many of these challenges. This smart stethoscope address all the challenges above by including (1) adaptive noise suppression that has been objectively and subjectively proven to be superior in all types of noise environments than traditional or other electronic stethoscopes, (2) on-board analysis algorithms that can detect crackles and wheezes in pediatric patients with an accuracy that matches that of a specialist, and (3) a uniform pickup surface that removes the requirement for exact placement of the device to get an accurate recording. In this project, we will validate that the device can be correctly used by parents of children with asthma and accurate recordings can be taken that are similar in quality to those that would be taken by a medical professional. Simultaneously, we will be using patient feedback to iterate on the device and mobile app design to create a version that patients are comfortable using in their home. Once the device and app have been validated in Phase I, we plan to move into directly into Phase II where the device will enter in a second phase of investigation that will include a first-time longitudinal study from parents of pediatric patients taking daily recordings in their home. This data will then be used for the development of algorithms to determine lung sound severities with metrics that can be tracked and predicted over time. In parallel to the this clinical study and algorithm development, recordings will be taken of adult patients with COPD to expand the usability of the device beyond pediatrics.