imPulse™ Una Full-spectrum, Over Clothing E-stethoscope

SARS-CoV-2/COVID-19 Study of the Audible and Inaudible Vibroacoustic E-stethoscope - imPulse™ Una

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04556149

Enrollment

Registered

2020-09-21

Start date

2020-10-01

Completion date

2020-12-02

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus, Corona Virus Infection

Keywords

infrasound, e-stethoscope, biosignature, SARS-CoV-2/COVID-19

Brief summary

This study generates robust clinical data to train ML/AI algorithms of the Sponsor's imPulse™ Una full-spectrum e-stethoscope for digital diagnostic feature synthesis of symptomatic SARS-CoV-2/COVID-19 biosignatures for rapid and accurate mass screening.

Detailed description

This study is designed to evaluate the ability of the imPulse™ Una e-stethoscope to differentiate vibroacoustic signals in inpatients with and without confirmed COVID-19 as the first step to establish the performance characteristics - sensitivity, specificity, positive and negative predictive value - of the imPulse™ Una device for early and rapid, point-of-care diagnosis of COVID-19. This will inform the utility and design of further larger-scale studies using the device.

Interventions

DEVICEimPulse™ Una 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.

DEVICEPhilips Lumify Ultrasound System

Point-of-care ultrasound

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Individuals hospitalized within a Johns Hopkins-affiliated hospital * Able to understand and willingness to comply with study procedures * Cases - inpatients with positive COVID-19 PCR test, collected from a respiratory sample within the last 7 days, AND pulmonary symptoms within 72 hours of enrollment * Controls - inpatients without COVID-19 diagnosis and no pulmonary diagnosis or symptoms * Cases or Control not able to sit or stand will be allowed to participate in just the parts of the staircase exam they're capable of doing.

Exclusion criteria

* Assisted ventilation, including high flow nasal cannula, or ventilator support * Unable to comply with study procedures, defined at investigator's discretion * Participants with any visible skin infections or open wounds in areas where the imPulse™ Una device would be applied

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic performance characteristics	through study completion, an average of 2 weeks	Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026