You are here

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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R42HL147728-02
Agency Tracking Number: R42HL147728
Amount: $1,148,290.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA18-575
Solicitation Year: 2018
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-08-20
Award End Date (Contract End Date): 2023-07-31
Small Business Information
Baltimore, MD 21224-3671
United States
DUNS: 114396584
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (410) 417-8167
Business Contact
Phone: (410) 417-8167
Research Institution
BALTIMORE, MD 21218-2680
United States

 Nonprofit College or University

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 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.Project Narrative
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.

* Information listed above is at the time of submission. *

US Flag An Official Website of the United States Government