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NCT Number: NCT06070298

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Valvular Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases Heart Murmurs Heart Valve Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary Hospital

Hong Kong, Hong Kong SAR, China

Who can participate

Healthy volunteers accepted: No

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

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

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. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Number of Adverse Events Reported by Participants Deemed to be Caused by the Observational Procedures

    Time frame: Day 0 to Day 1

Sponsors and collaborators

Lead sponsor

Wong Chun Ka

Other

Collaborators

  • Laboratory of Data Discovery for Health
  • The University of Hong Kong

Registry information

Official study title

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

Acronym: AUSC1

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 6, 2023
Registry last updated
Apr 24, 2025

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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