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

NCT ID: NCT04556149

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2020-12-02

Brief Summary

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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

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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.

Conditions

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Corona Virus Infection Coronavirus

Keywords

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

Inpatients with confirmed COVID-19 with pulmonary symptoms

imPulse™ Una e-stethoscope

Intervention Type DEVICE

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.

Philips Lumify Ultrasound System

Intervention Type DEVICE

Point-of-care ultrasound

Matched Control

Inpatients without COVID-19 with non-pulmonary diagnoses or symptoms

imPulse™ Una e-stethoscope

Intervention Type DEVICE

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.

Philips Lumify Ultrasound System

Intervention Type DEVICE

Point-of-care ultrasound

Interventions

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imPulse™ 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.

Intervention Type DEVICE

Philips Lumify Ultrasound System

Point-of-care ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schmidt Futures

UNKNOWN

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Level 42 AI, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kelly Dooley, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Ed Fuchs, MBA

Role: STUDY_DIRECTOR

Johns Hopkins School of Medicine

Locations

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Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Dooley KE, Morimoto M, Kaszuba P, Krasne M, Liu G, Fuchs E, Rexelius P, Swan J, Krawiec K, Hammond K, Ray SC, Hafen R, Schuh A, Jumbe NLS. Evidence Generation for a Host-Response Biosignature of Respiratory Disease. Viruses. 2025 Jul 2;17(7):943. doi: 10.3390/v17070943.

Reference Type DERIVED
PMID: 40733560 (View on PubMed)

Other Identifiers

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00110011

Identifier Type: -

Identifier Source: org_study_id