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.
This proposal aims to validate a smart auscultation device for home use and develop algorithms that can track changes in, and severity of, lung sounds in order to monitor patients over long periods of time, improve the clinical relevance of home monitoring for timely interventions, and decrease hospital admissions. Current state of the art technology available to patients suffering from asthma and COPD is unable to intelligently monitor patients at home and no long-term monitoring solutions exist for these conditions, resulting in increases in emergency department visits. The academic partner has developed a smart stethoscope that offers greatly improved audio fidelity in any type of noise environment, automated on-board analysis and detection algorithms of lung sounds, and increased ease of use. The small business partner is in the process of commercializing the device for clinical use by trained, professional personnel. Together, we are aiming to test whether the device can be reliably used by non-trained personnel for home use, develop algorithms that would provide metrics for monitoring trends and severities of lung sounds and predict future severity, expand the current abilities of the stethoscope from pediatrics to all patients, and transfer this technology to the small business partner for further clinical testing and commercial development such that it can improve the long-term outcome for patients with chronic lung conditions.
