COVID-19PassiveDetecNCT05765396
SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies (Level42)
An observational study of COVID-19 and SARS-CoV-2 Virus, run by The Geneva Foundation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2 Virus, COVID-19 Pneumonia
- What is being tested?
- imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscope
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asymptomatic and symptomatic individuals age 18 and older undergoing COVID-19, Flu, and/or RSV screening and testing at Brooke Army Medical Center (BAMC), Ft Sam Houston TX, with and without COVID-19, Flu, and/or RSV diagnosis within 48hrs of consent.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: 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:
Read more
(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.)
Read the 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. In 2018, respiratory infections like respiratory syncytial virus (RSV), accounted for an estimated 50,000 medical encounters affecting about ~35,000 recruits that resulted in 1,000 hospital bed days leading to significant loss in training time and cost. In addition to annual respiratory infections such as influenza, on-going COVID-19, which has claimed the lives of 210,000 Americans, continues to threaten to further degrade operational readiness. 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.
Regaining American technological supremacy will require a pivot from the large, exquisite, hardware- defined systems that won us the conflicts of last century to larger numbers of lower-cost, attritable,smaller, software-defined systems. This is particularly critical as the country reopens, and life returns to normal, thus long-term technological technology platforms must be able to secure entry to workplaces, airplanes, schools, stadiums, theaters, mass transit center, ports-of-entry, malls and restaurants.
Current CLIA laboratory diagnostic procedures, such Enzyme Linked Immunosorbent Assay (ELISA), Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), and bacterial cultures, are costly, time- consuming, and operator sensitive. It has become apparent that during the dynamic COVID-19 pandemic, these approaches are insufficient in meeting diagnostic needs as they are difficult to scale-up and lack logistical flexibility. Furthermore, 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 will- modify and operationalize existing innovative passive surveillance systems that can be deployed in the near-term.
The Level 42 AI imPulseTM UNA and TOR are both over-clothing e-stethoscope and stand-off systems which 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. The Level 42 AI imPulseTM TOR improves upon the UNA and adds the capabiliy to perform non-contact, alternating multi-lead electrocardiogram (ECG) and electromyography (EMG) sensors along with existing broad-spectrum vibroacoustic biosignature sensors. This allows the TOR to collect six types of inaudible vibrations and audible sounds as i) Korotkoff sounds and murmurs, ii) heartbeat, iii) respiratory rhythm, iv) gut motility, v) carotid tree blood flow and resistance, and vi) Traube-Hering waves, which measure states of stress tension.
- Conditions
- COVID-19, SARS-CoV-2 Virus, COVID-19 Pneumonia, Respiratory Infection, COVID-19 ARDS, Corona Virus Infection
- Being tested
- imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscope
- Keywords
- COVID-19, Diagnostic Product, e-stethoscope, military, Flu, RSV, Passive Detection, Level 42
- Medical subject headings
- COVID-19, Respiratory Tract Infections, Coronavirus Infections, Influenza, Human, Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscopeDevice
Also called imPulse™ Una, e-stethoscope, Passive Detection, imPulse™ TOR
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscope | |
| 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. Receives: Device: imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital vibroacoustic biomarker diagnostic performance characteristics specific to imPulse™ Una
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.
Measured: Enrollment through to study completion (min 48hrs through to 24 months)
imPulse™ Una infrasound-to-ultrasound e-stethoscope device usability
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
Measured: Enrollment through to study completion (min 48hrs through to 24 months)
imPulse™ TOR infrasound-to-ultrasound e-stethoscope device usability
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
Measured: Enrollment through to study completion (min 48hrs through to 24 months)
Digital vibroacoustic biomarker diagnostic performance characteristics specific to imPulse™ TOR
Sensitivity, specificity, positive and negative predictive values - of the imPulse™ TOR device for point-of-care diagnosis of COVID-19, Flu, and/or RSV among symptomatic and asymptomatic COVID-19, Flu, and/or RSV carrier versus those not infected compared to gold standard RT-PCR.
Measured: Enrollment through to study completion (min 48hrs through to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start15 May 2023
- Primary completion30 Dec 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Geneva Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Brooke Army Medical Center, Uniformed Services University of the Health Sciences, Level 42 AI, Inc.
- Responsible party
- Sponsor
- Investigators
- Tony T Yuan, PhD, Principal investigator, Uniformed Services University of the Health Sciences (USUHS)Michael Morris, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765396
- Sponsor's protocol ID
- C.2023.007
- Acronym
- PassiveDetec
- Status last verified
- Aug 2025
- First submitted
- 9 Mar 2023
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clemmons NS, McCormic ZD, Gaydos JC, Hawksworth AW, Jordan NN. Acute Respiratory Disease in US Army Trainees 3 Years after Reintroduction of Adenovirus Vaccine 1. Emerg Infect Dis. 2017 Jan;23(1):95-98. doi: 10.3201/eid2301.161297. Epub 2017 Jan 15.
PubMed 27748651Sanchez JL, Cooper MJ, Myers CA, Cummings JF, Vest KG, Russell KL, Sanchez JL, Hiser MJ, Gaydos CA. Respiratory Infections in the U.S. Military: Recent Experience and Control. Clin Microbiol Rev. 2015 Jul;28(3):743-800. doi: 10.1128/CMR.00039-14.
PubMed 26085551Armed Forces Health Surveillance Center (AFHSC). Surveillance Snapshot: illness and injury burdens among U.S. military recruit trainees, 2012. MSMR. 2013 Apr;20(4):24. No abstract available.
PubMed 23617314Murray CJ, Lopez AD. Measuring the global burden of disease. N Engl J Med. 2013 Aug 1;369(5):448-57. doi: 10.1056/NEJMra1201534. No abstract available.
PubMed 23902484Alahi MEE, Mukhopadhyay SC. Detection Methodologies for Pathogen and Toxins: A Review. Sensors (Basel). 2017 Aug 16;17(8):1885. doi: 10.3390/s17081885.
PubMed 28813028
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies
- ClinicalTrials.gov ID
- NCT05765396
- Acronym / sponsor ID
- PassiveDetec / C.2023.007
- Conditions
- COVID-19, SARS-CoV-2 Virus, COVID-19 Pneumonia, Respiratory Infection, COVID-19 ARDS, Corona Virus Infection
- Keywords
- COVID-19, Diagnostic Product, e-stethoscope, military, Flu, RSV, Passive Detection, Level 42
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The Geneva FoundationUniversity, hospital or other
- Collaborators
- Brooke Army Medical Center, Uniformed Services University of the Health Sciences, Level 42 AI, Inc.
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
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. In 2018, respiratory infections like respiratory syncytial virus (RSV), accounted for an estimated 50,000 medical encounters affecting about ~35,000 recruits that resulted in 1,000 hospital bed days leading to significant loss in training time and cost. In addition to annual respiratory infections such as influenza, on-going COVID-19, which has claimed the lives of 210,000 Americans, continues to threaten to further degrade operational readiness. 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.
Regaining American technological supremacy will require a pivot from the large, exquisite, hardware- defined systems that won us the conflicts of last century to larger numbers of lower-cost, attritable,smaller, software-defined systems. This is particularly critical as the country reopens, and life returns to normal, thus long-term technological technology platforms must be able to secure entry to workplaces, airplanes, schools, stadiums, theaters, mass transit center, ports-of-entry, malls and restaurants.
Current CLIA laboratory diagnostic procedures, such Enzyme Linked Immunosorbent Assay (ELISA), Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), and bacterial cultures, are costly, time- consuming, and operator sensitive. It has become apparent that during the dynamic COVID-19 pandemic, these approaches are insufficient in meeting diagnostic needs as they are difficult to scale-up and lack logistical flexibility. Furthermore, 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 will- modify and operationalize existing innovative passive surveillance systems that can be deployed in the near-term.
The Level 42 AI imPulseTM UNA and TOR are both over-clothing e-stethoscope and stand-off systems which 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. The Level 42 AI imPulseTM TOR improves upon the UNA and adds the capabiliy to perform non-contact, alternating multi-lead electrocardiogram (ECG) and electromyography (EMG) sensors along with existing broad-spectrum vibroacoustic biosignature sensors. This allows the TOR to collect six types of inaudible vibrations and audible sounds as i) Korotkoff sounds and murmurs, ii) heartbeat, iii) respiratory rhythm, iv) gut motility, v) carotid tree blood flow and resistance, and vi) Traube-Hering waves, which measure states of stress tension.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19, Flu, and/or RSV positive patients | – | Device: imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscopeParticipants 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 | – | Device: imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscopeParticipants screened with known COVID-19, Flu, and/or RSV negative test results obtained within 48hrs of recruitment. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asymptomatic and symptomatic individuals age 18 and older undergoing COVID-19, Flu, and/or RSV screening and testing at Brooke Army Medical Center (BAMC), Ft Sam Houston TX, with and without COVID-19, Flu, and/or RSV diagnosis within 48hrs of consent.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscopeAlso: imPulse™ Una, e-stethoscope, Passive Detection, imPulse™ TORThe 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. | Device | COVID-19, Flu, and/or RSV negative patients, COVID-19, Flu, and/or RSV positive patients |
Primary outcome
Digital vibroacoustic biomarker diagnostic performance characteristics specific to imPulse™ Una
Time frame: Enrollment through to study completion (min 48hrs through to 24 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.
imPulse™ Una infrasound-to-ultrasound e-stethoscope device usability
Time frame: Enrollment through to study completion (min 48hrs through to 24 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
imPulse™ TOR infrasound-to-ultrasound e-stethoscope device usability
Time frame: Enrollment through to study completion (min 48hrs through to 24 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
Digital vibroacoustic biomarker diagnostic performance characteristics specific to imPulse™ TOR
Time frame: Enrollment through to study completion (min 48hrs through to 24 months)
Sensitivity, specificity, positive and negative predictive values - of the imPulse™ TOR device for point-of-care diagnosis of COVID-19, Flu, and/or RSV among symptomatic and asymptomatic COVID-19, Flu, and/or RSV carrier versus those not infected compared to gold standard RT-PCR.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 27748651Clemmons NS, McCormic ZD, Gaydos JC, Hawksworth AW, Jordan NN. Acute Respiratory Disease in US Army Trainees 3 Years after Reintroduction of Adenovirus Vaccine 1. Emerg Infect Dis. 2017 Jan;23(1):95-98. doi: 10.3201/eid2301.161297. Epub 2017 Jan 15.
- Background: PubMed 26085551Sanchez JL, Cooper MJ, Myers CA, Cummings JF, Vest KG, Russell KL, Sanchez JL, Hiser MJ, Gaydos CA. Respiratory Infections in the U.S. Military: Recent Experience and Control. Clin Microbiol Rev. 2015 Jul;28(3):743-800. doi: 10.1128/CMR.00039-14.
- Background: PubMed 23617314Armed Forces Health Surveillance Center (AFHSC). Surveillance Snapshot: illness and injury burdens among U.S. military recruit trainees, 2012. MSMR. 2013 Apr;20(4):24. No abstract available.
- Background: PubMed 23902484Murray CJ, Lopez AD. Measuring the global burden of disease. N Engl J Med. 2013 Aug 1;369(5):448-57. doi: 10.1056/NEJMra1201534. No abstract available.
- Background: PubMed 28813028Alahi MEE, Mukhopadhyay SC. Detection Methodologies for Pathogen and Toxins: A Review. Sensors (Basel). 2017 Aug 16;17(8):1885. doi: 10.3390/s17081885.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony T Yuan, PhD principal investigator
Uniformed Services University of the Health Sciences (USUHS)
Michael Morris, MD principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV-2 Virus, run by The Geneva Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital vibroacoustic biomarker diagnostic performance characteristics specific to imPulse™ Una (time frame: Enrollment through to study completion (min 48hrs through to 24 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05765396, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.