ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.)

Official Title

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

Quick Facts

Study Start:2023-05-15
Study Completion:2026-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05765396

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Asymptomatic and symptomatic individuals 18 years and older
  2. * Receiving standard COVID-19, Flu, and/or RSV screening and testing at BAMC
  3. * Do not have to be diagnosed with SARS-CoV-19 (COVID-19), Flu, and/or RSV but only be screened
  4. * English Speaking
  1. * Any individual under age of 18
  2. * Anyone unable to comply (or be assisted) with study procedures
  3. * Anyone not able to provide temperature thermal scan, and/or 3-minute vibroacoustic scan

Contacts and Locations

Principal Investigator

Tony T Yuan, PhD
PRINCIPAL_INVESTIGATOR
Uniformed Services University of the Health Sciences (USUHS)
Michael Morris, MD
PRINCIPAL_INVESTIGATOR
Brooke Army Medical Center

Study Locations (Sites)

Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States

Collaborators and Investigators

Sponsor: The Geneva Foundation

  • Tony T Yuan, PhD, PRINCIPAL_INVESTIGATOR, Uniformed Services University of the Health Sciences (USUHS)
  • Michael Morris, MD, PRINCIPAL_INVESTIGATOR, Brooke Army Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-15
Study Completion Date2026-03-30

Study Record Updates

Study Start Date2023-05-15
Study Completion Date2026-03-30

Terms related to this study

Keywords Provided by Researchers

  • COVID-19 diagnostic product, e-stethoscope, military, Flu, RSV, Passive Detection, Level 42

Additional Relevant MeSH Terms

  • 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