SONAVI LABS INC — Department of Health and Human Services SBIR Phase I: 102

Description

Project SummaryThe 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 asthmaLung diseases impose a serious burden on healthcare systemsindividuals and governmentsWHO recognizes asthma as the leading chronic disease in children and estimates thatmillion people suffer from the disease worldwidewith overdeaths from the disease inIn the United Statesasthma prevalence and disease burden disproportionately affect Blacks or African Americans compared with White AmericansFromtothe annual US asthma prevalencefor Black Americans versusin Caucasiansmortality rateversusperpatients per yearand emergency department visitsversusvisits perpatients per yearwere all worse among Blacks or African AmericansThe fundamental causes of health disparities in relation to asthma are well understoodurban air pollutionhousingpoor dietpovertyand social and or geographical isolationbut remain very difficult to solveEarly technological and mobile applications for remote management have attempted to address these problemswith somewhat positive resultsbut require patient self assessment and do not include objective monitoring of lung statusA small number of wheeze detectors and pulmonary monitors have been approved for marketing by the FDAbut face several technological limitations and are not commercially available in the USWe reasoned that a long term monitoring solution that can be used in the home by untrained patientsor family members of patientscould detect and monitor severity of airway inflammation in patientsprovide insight into reasons for worsening or improved symptomsprovide tailored educational content and direct patients to medical follow before the situation becomes acutethus reducing trips to emergency departments and readmission rates to hospitalsWe find that several challenges exist when considering long term auscultatory monitoring solutions in non traditional clinical settingsunpredictable ambient noisethe need for medical expertise to interpret lung soundssubjectivity in the analysisanddifficulty using and placing the stethoscopeIn order to overcome many of these challengesthe 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 wheezesThis smart stethoscope address all the challenges above by includingadaptive noise suppression that has been objectively and subjectively proven to be superior in all types of noise environments than traditional or other electronic stethoscopeson board analysis algorithms that can detect crackles and wheezes in pediatric patients with an accuracy that matches that of a specialistanda uniform pickup surface that removes the requirement for exact placement of the device to get an accurate recordingIn this projectwe will validate that the device can be correctly used by parents of children with asthma through monitoring over aweek period following an ED visit through daily recordingsWe then plan to confirm that our existing detection algorithms can be used or modified to track changes in the lung sound severityfollowed by correlating these algorithm outputs with patient reported outcomes and environmental dataSimultaneouslywe will be using patient feedback to iterate on the device design to create a version that minority and underserved patients are comfortable using in their home This proposal aims to validate a smart auscultation device for home use and develop algorithms that can track changes inand severity ofwheezes and lung sounds in order to monitor patients over long periods of timeimprove the clinical relevance of home monitoring for timely interventionsand decrease hospital admissionsCurrent state of the art technology available to minority patients suffering from asthma is unable to intelligently monitor patients at home and no long term monitoring solutions exist for these conditionsresulting in increases in emergency department visitsespecially of underserved patient populationsThe academic partner has developed a smart stethoscope that offers greatly improved audio fidelity in any type of noise environmentautomated on board analysis and detection algorithms of lung soundsand increased ease of useThe small business partner is in the process of commercializing the device for clinical use by trainedprofessional personnelTogetherwe are aiming to test whether the device can be reliably used by non trained personnel for home usedevelop algorithms that would provide metrics for monitoring trends and severities of lung soundsand make this technology easily available to and usable by afflicted populations such that it can improve the long term outcome for patients and decrease the burden on underserved groups