SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies

Summary

The goal of this observational study is to evaluate new non-invasive passive surveillance technologies, 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 undergoing COVID-19, Flu, and/or RSV screening and testing at BAMC Ft Sam Houston, TX; with and without COVID-19, Flu, and/or RSV.

The hypotheses are:

(H1) The imPulseTM Una and the imPulseTM TOR e-stethoscopes have at least a similar discriminative and detection ability among symptomatic and asymptomatic COVID-19 carrier versus those not infected compared to gold standard RT-PCR. We will operationalize and deploy both the imPulseTM Una and imPulseTM TOR e-stethoscope into DoD use-cases and compare their usability between the devices.

(H2) Identify if the imPulseTM Una and the imPulseTM TOR e-stethoscopes have at least a similar discriminative and detection ability among symptomatic and asymptomatic Respiratory Syncytial Virus (RSV), Influenza and Long COVID carriers versus those not infected compared to gold standard Rapid RSV and Flu Antigen Tests, or RT-PCR and molecular assays. We will operationalize and deploy both the imPulseTM Una and imPulseTM TOR e-stethoscope into DoD use-cases and compare their captured traces in the early identification 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 system to explore pursue the physical (structural and mechanical) properties of cells and tissues that maintain normal cell behavior (motility, growth, apoptosis), and the critical importance of the ability of cells to sense and respond to mechanical stresses, which will be operationally critical for assessment of both traumatic and unconventional exposures 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.)

Conditions

• COVID-19
• SARS-CoV-2 Virus
• COVID-19 Pneumonia
• COVID-19 Respiratory Infection
• COVID-19 Acute Respiratory Distress Syndrome
• Corona Virus Infection
• Influenza
• RSV Infection

Interventions

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.

Sponsors & Collaborators

• Brooke Army Medical Center

  collaborator FED

• Uniformed Services University of the Health Sciences

  collaborator FED

• Level 42 AI, Inc.

  collaborator INDUSTRY

• The Geneva Foundation

  lead OTHER

Principal Investigators

• Tony T Yuan, PhD · Uniformed Services University of the Health Sciences (USUHS)

• Michael Morris, MD · Brooke Army Medical Center

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-15

Primary Completion

2025-12-30

Completion

2026-03-30

Countries

• United States

Study Locations