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Clinical feasibility of a non-invasive, low-cost wearable for measuring air trapping in COPD

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL152769-01A1
Agency Tracking Number: R41HL152769
Amount: $350,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA19-271
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-07-20
Award End Date (Contract End Date): 2021-06-30
Small Business Information
Mountain View, CA 94040-1351
United States
DUNS: 081197476
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (617) 999-3735
Business Contact
Phone: (617) 999-3735
Research Institution
SAN FRANCISCO, CA 94121-1563
United States

 Domestic Nonprofit Research Organization

ABSTRACTChronic Obstructive Pulmonary Disease (COPD) is the third leading cause of hospitalization in the US.
Exacerbations - a worsening or “flare up” of symptoms - cause most COPD hospitalizations. Since most
exacerbations can be treated with changes of inhalers and/or oral medications, at-home detection of lung
function deterioration may facilitate earlier intervention and help delay or prevent hospitalizations. The
Standards of Care for monitoring lung function are spirometry, plethysmography, and CT scan. However, these
are expensive methods and unsuited for continuous monitoring or at-home use. Various patient self-monitoring
approaches have been tried, for example, pulse oximetry, respiratory rate monitoring, and peak flow metering,
but their efficacy in reducing hospitalizations has been limited.A common finding for all forms of COPD is air trapping, defined, as an abnormal increase in the volume
of air remaining in the lungs after exhalation is complete. A body of evidence definitively shows that air trapping
increases during exacerbations and decreases when exacerbations resolve. Recent reports show that air
trapping is an earlier harbinger of deteriorating lung function than spirometric changes, and can be measured
by low-frequency ultrasound (1-40 kHz). Acoustic monitoring of air trapping could provide clinicians with a non-
invasive tool when medical intervention is needed to avoid unnecessary ER visits and hospitalizations.Respira Labs has developed a low-cost, non-invasive, acoustic-based wearable device that can
continually monitor lung resonance: Sylvee. The device uses known acoustic-based technology with machine-
learning algorithms to detect minor changes in lung resonance, which our preliminary results suggest
correspond to changes in air trapping. The overall objective of this project is to validate Sylveeandapos;s air trapping
algorithms in a cohort of 20 healthy controls and 40 COPD patients with and without air trapping, respectively.
In Aims 1 and 2, we will miniaturize and add sensors to the Sylvee device and develop a user interface (UI)
and a mobile application. In Aims 3 and 4, we will create an Air Trapping Index Report and validate it in a
cross-sectional study vis-à-vis whole body plethysmography as a control. Results of this project provide a
go/no-go development decision based on device function. We can apply these results in STTR Phase II, in a
larger clinical study to evaluate Sylvee as an at-home monitoring system, with a goal of reducing
hospitalizations by at least 30%. Ultimately, Sylvee will allow physicians to remotely monitor their patientsandapos; lung
function and adjust their medications to reduce healthcare costs and improve patientsandapos; quality of life.PROJECT NARRATIVE
More than 12 million Americans have been diagnosed with COPD, and another 17 million may have COPD,
but are unaware of it. By 2020, the costs associated with COPD are estimated to be $72B billion per year, of
which with ~50% are the costs of spent on ER visits and hospitalizations. The goal of this proposal is to
establish and validate a seamless and non-obtrusive wearable that measures abnormal air trapping via a novel
acoustic technology, which would reduce hospitalizations through at-home monitoring of lung function.

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

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