The goal of this observational study is to evaluate new non-invasive passive surveillancetechnologies, Level 42 AI imPulse™ Una and TOR devices for the detection of COVID-19,Flu, and/or RSV in asymptomatic and symptomatic individuals over age of 18 undergoingCOVID-19, Flu, and/or RSV screening and testing at BAMC Ft Sam Houston, TX; with andwithout COVID-19, Flu, and/or RSV.The hypotheses are:(H1) The imPulseTM Una and the imPulseTM TOR e-stethoscopes have at least a similardiscriminative and detection ability among symptomatic and asymptomatic COVID-19 carrierversus those not infected compared to gold standard RT-PCR. We will operationalize anddeploy both the imPulseTM Una and imPulseTM TOR e-stethoscope into DoD use-cases andcompare their usability between the devices.(H2) Identify if the imPulseTM Una and the imPulseTM TOR e-stethoscopes have at least asimilar discriminative and detection ability among symptomatic and asymptomaticRespiratory Syncytial Virus (RSV), Influenza and Long COVID carriers versus those notinfected compared to gold standard Rapid RSV and Flu Antigen Tests, or RT-PCR andmolecular assays. We will operationalize and deploy both the imPulseTM Una and imPulseTMTOR e-stethoscope into DoD use-cases and compare their captured traces in the earlyidentification of disease/illness analyzed by the devices built in algorithms.(H3) In the mid to long-term, this approach will also be explored as a diagnostic systemto explore pursue the physical (structural and mechanical) properties of cells andtissues that maintain normal cell behavior (motility, growth, apoptosis), and thecritical importance of the ability of cells to sense and respond to mechanical stresses,which will be operationally critical for assessment of both traumatic and unconventionalexposures in austere environments.Participants will: - Be consented; - Be screened for COVID-19, Flu, and/or RSV symptoms according to BAMC's current screening procedures; - Have study data collected; - Complete a symptoms questionnaire; - imPulseTM Una and TOR e-stethoscopes examination will be conducted; - Participants will be compensated for completing all study requirements. (Active-Duty personnel must complete the study procedures while off-duty in order to receive compensation.)
Emerging acute respiratory diseases (ARDs) pose a significant threat for the US military,
especially among those in training environments where crowded living conditions and
demanding multi-factorial stresses exacerbate infection exposure and suppress immunity,
respectively. Consequently, ARD rates are routinely reported higher in recruits than
older military personnel, which have a detrimental effect on operational readiness.
Although significant steps, such as surveillance and vaccine programs, have been taken to
minimize the impact that ARDs have on military recruits and newly mobilized troops,
hospitalizations among recruits still exceeds that of comparable civilian population in
the United States by at least 3- to 4- folds, accounting for almost 30% of all infectious
disease associated hospitalizations. In 2018, respiratory infections like respiratory
syncytial virus (RSV), accounted for an estimated 50,000 medical encounters affecting
about ~35,000 recruits that resulted in 1,000 hospital bed days leading to significant
loss in training time and cost. In addition to annual respiratory infections such as
influenza, on-going COVID-19, which has claimed the lives of 210,000 Americans, continues
to threaten to further degrade operational readiness. Thus, inexpensive, rapid, and more
reliable diagnostics are continually required to better treat and prevent ARDs to
preserve military readiness and decrease disability adjusted life years.
Regaining American technological supremacy will require a pivot from the large,
exquisite, hardware- defined systems that won us the conflicts of last century to larger
numbers of lower-cost, attritable,smaller, software-defined systems. This is particularly
critical as the country reopens, and life returns to normal, thus long-term technological
technology platforms must be able to secure entry to workplaces, airplanes, schools,
stadiums, theaters, mass transit center, ports-of-entry, malls and restaurants.
Current CLIA laboratory diagnostic procedures, such Enzyme Linked Immunosorbent Assay
(ELISA), Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), and bacterial
cultures, are costly, time- consuming, and operator sensitive. It has become apparent
that during the dynamic COVID-19 pandemic, these approaches are insufficient in meeting
diagnostic needs as they are difficult to scale-up and lack logistical flexibility.
Furthermore, due to the invasive nature of active clinical sampling, there is a critical
need for accurate and rapid passive surveillance as to screen for SARS-CoV-19 as well as
other hazardous chemical and biological agents. To address this capability gap, the
current project will- modify and operationalize existing innovative passive surveillance
systems that can be deployed in the near-term.
The Level 42 AI imPulseTM UNA and TOR are both over-clothing e-stethoscope and stand-off
systems which are intended to be used to identify characteristic and subtle changes in
audible and inaudible sounds changes in the upper and lower respiratory tract driven by
airflow velocity, hydration, pressure, and wall shear stress for both inspiration
(velocity splitting) and expiration (velocity merging) during active infection vs.
health. The Level 42 AI imPulseTM TOR improves upon the UNA and adds the capabiliy to
perform non-contact, alternating multi-lead electrocardiogram (ECG) and electromyography
(EMG) sensors along with existing broad-spectrum vibroacoustic biosignature sensors. This
allows the TOR to collect six types of inaudible vibrations and audible sounds as i)
Korotkoff sounds and murmurs, ii) heartbeat, iii) respiratory rhythm, iv) gut motility,
v) carotid tree blood flow and resistance, and vi) Traube-Hering waves, which measure
states of stress tension.
Device: imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscope
The imPulse™ Systems are an every/anywhere-point-of-care cardiopulmonary functional state
assessment platform designed to capture normal and abnormal, audible and inaudible
cardiopulmonary sounds, rhythms and patterns, via a real-time, intelligent, full-spectrum
phonocardiogram obtained from direct to skin coupling or through a layer of clothing.
Other Name: imPulse™ Una,e-stethoscope,Passive Detection,imPulse™ TOR
Inclusion Criteria:
- Asymptomatic and symptomatic individuals 18 years and older
- Receiving standard COVID-19, Flu, and/or RSV screening and testing at BAMC
- Do not have to be diagnosed with SARS-CoV-19 (COVID-19), Flu, and/or RSV but only be
screened
- English Speaking
Exclusion Criteria:
- Any individual under age of 18
- Anyone unable to comply (or be assisted) with study procedures
- Anyone not able to provide temperature thermal scan, and/or 3-minute vibroacoustic
scan
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Investigator: Katherine Walker-Rodriguez, MSN
Contact: 210-378-3057
katherine.c.walker-rodriguez.ctr@health.mil
Tony T Yuan, PhD
214-292-0508
tony.yuan@usuhs.edu
Katherine Walker-Rodriguez, MSN
210-378-3057
katherine.c.walker-rodriguez.ctr@health.mil