Can Smartphones Listen to Your Heart? A Performance Study on Detecting Inborn Heart Diseases in Your Heart Sounds (AUSC-CHD)

June 22, 2026 updated by: Wong Chun Ka, The University of Hong Kong

Smartphone-Based Use of Phonocardiography for Detection of Congenital Heart Disease: Diagnostic Performance Study

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 normal attendance at the hospitals 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)

220

Contacts and Locations

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

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Kowloon Bay, Hong Kong
        • Hong Kong Children's 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Paediatric and adult hospital patients who have undergone echocardiography within 3 years.

Description

Inclusion Criteria:

  • Age: ≥ 6 years
  • Have undergone echocardiography within 3 years at their normal non-research hospital attendance

Exclusion Criteria:

  • Implanted active medical devices in the torso, such as pacemakers and defibrillators
  • Have purely non-congenital valvular heart disease

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
Differentiation of Murmurs Associated with Congenital Heart Disease from Normal Heart Sounds and Innocent Murmurs in Heart Sound Recordings
Time Frame: Day 0
Identification of murmurs associated with congenital heart disease from normal heart sounds and innocent murmurs in recorded heart sounds (phonocardiogram [PCG]), measured in the form of sensitivity and specificity.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differentiation of Murmurs Associated with Congenital Heart Disease from Normal Heart Sounds and Innocent Murmurs in Heart Sound Recordings
Time Frame: Day 0
Identification of murmurs associated with congenital heart disease from normal heart sounds and innocent murmurs in recorded heart sounds (phonocardiogram [PCG]), measured in the form of positive and negative predictive value and accuracy.
Day 0
Number of Adverse Events Reported by Participants or Child Participants' Parent/Legal Guardian During and at the End of Heart Sound Recording That are Determined to be Caused by This Study
Time Frame: Day 0
Day 0

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

Collaborators

Laboratory of Data Discovery for Health

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 26, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUSC-CHD
  • UW 25-328 (Other Identifier: Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be considered proprietary.

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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