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OpenTrials
Enrolling by Invitation

NCT Number: NCT07376785

Can Smartphones Listen to Your Heart? A Performance Study on Detecting Inborn Heart Diseases in Your Heart Sounds

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.

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Key information

Conditions

Congenital Heart Disease (CHD) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Murmurs Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary Hospital, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer algorithms

Diagnostic Test

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™

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Laboratory of Data Discovery for Health

Registry information

Official study title

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

Acronym: AUSC-CHD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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