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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: t
View:

• 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

Locations
United States
Texas
Brooke Army Medical Center
RECRUITING
Fort Sam Houston
Contact Information
Primary
Tony T Yuan, PhD
tony.yuan@usuhs.edu
214-292-0508
Backup
Katherine Walker-Rodriguez, MSN
katherine.c.walker-rodriguez.ctr@health.mil
210-378-3057
Time Frame
Start Date: 2023-05-15
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 300
Treatments
COVID-19, Flu, and/or RSV positive patients
Participants screened with known COVID-19, Flu, and/or RSV positive test results obtained within 48hrs of recruitment.
COVID-19, Flu, and/or RSV negative patients
Participants screened with known COVID-19, Flu, and/or RSV negative test results obtained within 48hrs of recruitment.
Sponsors
Collaborators: Brooke Army Medical Center, Level 42 AI, Inc., Uniformed Services University of the Health Sciences
Leads: The Geneva Foundation

This content was sourced from clinicaltrials.gov