SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies
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
🗓️ Study Start (Actual)
15 May 2023
🗓️ Primary Completion (Estimated)
30 March 2025
✅ Study Completion (Estimated)
30 April 2025
👥 Enrollment (Estimated)
300
🔬 Study Type
OBSERVATIONAL
📊 Phase
N/A
Locations:
📍
Fort Sam Houston, Texas, United States
Description
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
Ages Eligible for Study:
18 Years to 89 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Yes
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
- First Submitted
9 March 2023
- First Submitted that Met QC Criteria
9 March 2023
- First Posted
13 March 2023
Study Record Updates
- Last Update Submitted that Met QC Criteria
3 May 2024
- Last Update Posted
7 May 2024
- Last Verified
May 2024