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

June 7, 2023 updated by: The Geneva Foundation

The goal of this observational study is to evaluate new non-invasive passive surveillance technologies, Level 42 AI imPulse™ for the detection of COVID-19 in asymptomatic and symptomatic individuals over age of 18 undergoing COVID-19 screening and testing at BAMC Ft Sam Houston, TX; with and without COVID-19.

The hypotheses are:

(H1) The imPulse™ Una e-stethoscope has 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. Based on these promising studies, we will operationalize and deploy the imPulseTM Una e-stethoscope and other associated technology form factors into DoD use-cases.

(H2) 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 symptoms according to BAMC's current screening procedures;
  • Have study data collected;
  • Complete a COVID-19 symptoms questionnaire;
  • imPulseTM Una e-stethoscope 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.)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

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. Current gold standard laboratory procedures for respiratory infection detection are costly, time-consuming, and operator sensitive. It has become apparent that 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 aims to deploy novel innovative passive surveillance systems into existing COVID-19 testing lines to validate previous results and validate operational utilization.

The DoD needs fast, accurate, non-invasive, readily scalable, mass screening actionable tests that drive decisions leading to better human, structure, and equipment health outcomes. The required diagnostic tests should first, provide accurate diagnostic information, and second- the diagnostic information, when used in decision-making, should improve human, structure, and equipment health outcomes in a clinically quantifiable way.

The Level 42 AI imPulse™ over-clothing e-stethoscope and stand-off systems 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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Asymptomatic and symptomatic individuals age 18 and older undergoing COVID-19 screening and testing at Brooke Army Medical Center (BAMC), Ft Sam Houston TX, with and without COVID-19 diagnosis within 48hrs of consent.

Description

Inclusion Criteria:

  • Asymptomatic and symptomatic individuals 18 years and older
  • Receiving standard COVID-19 screening and testing at BAMC
  • Do not have to be diagnosed with SARS-CoV-19 (COVID-19) 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 positive patients
Participants screened with known COVID-19 positive test results obtained within 48hrs of recruitment.
Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope
The imPulse™ System is 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 Names:
  • imPulse™ Una
  • e-stethoscope
  • Passive Detection
COVID-19 negative patients
Participants screened with known COVID-19 negative test results obtained within 48hrs of recruitment.
Device: imPulse™ Una infrasound-to-ultrasound e-stethoscope
The imPulse™ System is 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 Names:
  • imPulse™ Una
  • e-stethoscope
  • Passive Detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digital vibroacoustic biomarker diagnostic performance characteristics
Time Frame: Enrollment through to study completion (min 48hrs through to 12 months)
Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19 among symptomatic and asymptomatic COVID-19 carrier versus those not infected compared to gold standard RT-PCR.
Enrollment through to study completion (min 48hrs through to 12 months)
imPulse™ Una infrasound-to-ultrasound e-stethoscope device usability
Time Frame: Enrollment through to study completion (min 48hrs through to 12 months)
Critical importance of the ability to sense and respond to mechanical stresses, which will be operationally critical for assessment of both traumatic and unconventional exposures in austere environments
Enrollment through to study completion (min 48hrs through to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Geneva Foundation

Collaborators

Uniformed Services University of the Health Sciences
Brooke Army Medical Center
Level 42 AI, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2023.007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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