Can a Smartphone Listen to Your Heart? A Performance Study on Detecting Abnormalities in Your Heart Sounds

December 21, 2023 updated by: Wong Chun Ka

Smartphone-Based Use of Phonocardiography Technique for Detection of Murmurs: Diagnostic Performance Study Protocol

This observational study aims to assess the performance of the software called ausculto™. ausculto™ is a collection of computer algorithms that intend to analyse heart sounds recorded from the built-in microphone of a smartphone for abnormal sounds.

Participants will have their heart sounds recorded during their regular clinic appointment after consenting to participate in this study.

Researchers will manually annotate the recorded heart sounds to create a database for use in future training and testing of artificial intelligence (AI) intended for medical uses.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

577

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

  • Name: Chun Ka Wong, MBBS
  • Phone Number: +852 2255 6233
  • Email: wongeck@hku.hk

Study Locations

  • China
    • Hong Kong SAR
      • Hong Kong, Hong Kong SAR, China
        • Queen Mary Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult hospital cardiology out-patients (22-year-old and above) who have undergone echocardiography within 3 years at their normal non-research follow-up clinic visit appointment.

Description

Inclusion Criteria:

  • Age: ≥22 years (adult)
  • Outpatients who have undergone echocardiography within 3 years at their normal non-research follow-up clinic visit appointment

Exclusion Criterion:

  • Implanted active medical devices in the torso, such as pacemakers and defibrillators

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
Abnormal Echocardiography Diagnosis
Participants with abnormal echocardiography diagnosis within three years.
Diagnostic test: Computer algorithms
Collection of lightweight computer algorithms called ausculto™ that is designed to perform real-time heart sound analysis to detect heart murmur.
Other Names:
  • ausculto™
  • Vitogram™
Normal Echocardiography Diagnosis
Participants with normal echocardiography diagnosis within three years.
Diagnostic test: Computer algorithms
Collection of lightweight computer algorithms called ausculto™ that is designed to perform real-time heart sound analysis to detect heart murmur.
Other Names:
  • ausculto™
  • Vitogram™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
Time Frame: Day 0
Sensitivity is defined as the percentage of true positives out of all positive cases from the ground truth. Cardiologist electronic stethoscope heart sound recording annotations paired with echocardiography diagnosis will be used as the ground truth. Heart sound recordings from electronic stethoscope will be rated by two independent cardiologists for presence or absence of murmur, with a third cardiologist consulted in case of disagreement.
Day 0
Specificity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
Time Frame: Day 0
Specificity is defined as the percentage of true negatives out of all negative cases from the ground truth. Cardiologist electronic stethoscope heart sound recording annotations paired with echocardiography diagnosis will be used as the ground truth. Heart sound recordings from electronic stethoscope will be rated by two independent cardiologists for presence or absence of murmur, with a third cardiologist consulted in case of disagreement.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of ausculto™ Using Auscultation as Ground Truth
Time Frame: Day 0
Sensitivity is defined as the percentage of true positives out of all positive cases from the ground truth. Cardiologist electronic stethoscope heart sound recording annotations will be used as the ground truth. Heart sound recordings from electronic stethoscope will be rated by two independent cardiologists for presence or absence of murmur, with a third cardiologist consulted in case of disagreement.
Day 0
Specificity of ausculto™ Using Auscultation as Ground Truth
Time Frame: Day 0
Specificity is defined as the percentage of true negatives out of all negative cases from the ground truth. Cardiologist electronic stethoscope heart sound recording annotations will be used as the ground truth. Heart sound recordings from electronic stethoscope will be rated by two independent cardiologists for presence or absence of murmur, with a third cardiologist consulted in case of disagreement.
Day 0
Sensitivity of ausculto™ Using Echocardiography as Ground Truth
Time Frame: Day 0
Sensitivity is defined as the percentage of true positives out of all positive cases from the ground truth. Echocardiography diagnosis will be used as the ground truth.
Day 0
Specificity of ausculto™ Using Echocardiography as Ground Truth
Time Frame: Day 0
Specificity is defined as the percentage of true negatives out of all negative cases from the ground truth. Echocardiography diagnosis will be used as the ground truth.
Day 0
Positive Predictive Value of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
Time Frame: Day 0
Positive predictive value is defined as the percentage of true positives out of all positive results from ausculto™. Cardiologist electronic stethoscope heart sound recording annotations paired with echocardiography diagnosis will be used as the ground truth. Heart sound recordings from electronic stethoscope will be rated by two independent cardiologists for presence or absence of murmur, with a third cardiologist consulted in case of disagreement.
Day 0
Negative Predictive Value of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth
Time Frame: Day 0
Negative predictive value is defined as the percentage of true negatives out of all negative results from ausculto™. Cardiologist electronic stethoscope heart sound recording annotations paired with echocardiography diagnosis will be used as the ground truth. Heart sound recordings from electronic stethoscope will be rated by two independent cardiologists for presence or absence of murmur, with a third cardiologist consulted in case of disagreement.
Day 0
Positive Predictive Value of ausculto™ Using Auscultation as Ground Truth
Time Frame: Day 0
Positive predictive value is defined as the percentage of true positives out of all positive results from ausculto™. Cardiologist electronic stethoscope heart sound recording annotations will be used as the ground truth. Heart sound recordings from electronic stethoscope will be rated by two independent cardiologists for presence or absence of murmur, with a third cardiologist consulted in case of disagreement.
Day 0
Negative Predictive Value of ausculto™ Using Auscultation as Ground Truth
Time Frame: Day 0
Negative predictive value is defined as the percentage of true negatives out of all negative results from ausculto™. Cardiologist electronic stethoscope heart sound recording annotations will be used as the ground truth. Heart sound recordings from electronic stethoscope will be rated by two independent cardiologists for presence or absence of murmur, with a third cardiologist consulted in case of disagreement.
Day 0
Positive Predictive Value of ausculto™ Using Echocardiography as Ground Truth
Time Frame: Day 0
Positive predictive value is defined as the percentage of true positives out of all positive results from ausculto™. Echocardiography diagnosis will be used as the ground truth.
Day 0
Negative Predictive Value of ausculto™ Using Echocardiography as Ground Truth
Time Frame: Day 0
Negative predictive value is defined as the percentage of true negatives out of all negative results from ausculto™. Echocardiography diagnosis will be used as the ground truth.
Day 0
Number of Adverse Events Reported by Participants Deemed to be Caused by the Observational Procedures
Time Frame: Day 0 to Day 1
Day 0 to Day 1

Collaborators and Investigators

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

Sponsor

Wong Chun Ka

Collaborators

The University of Hong Kong
Laboratory of Data Discovery for Health

Investigators

  • Principal Investigator: Chun Ka Wong, MBBS, The University of Hong Kong

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)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

September 29, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUSC1

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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