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Active, not recruiting Observational

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

NCT06070298 · tracked via the Priya Life Science China tracker
Sponsor
Wong Chun Ka
Phase
Observational
Started
2023-12-01
Last updated
2025-04-24

Condition(s) studied

Valvular Heart DiseaseHeart MurmursCardiovascular Abnormalities

Investigational drug(s) / intervention(s)

Computer algorithms

Computer algorithms: Collection of lightweight computer algorithms called ausculto™ that is designed to perform real-time heart sound analysis to detect heart murmur.

Study summary

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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Sensitivity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth — 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.
  • Specificity of ausculto™ Using Auscultation Paired with Echocardiography as Ground Truth — 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.

Trial sites (1)

FacilityCityRegionStatus
Queen Mary Hospital Hong Kong Hong Kong SAR
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06070298 on ClinicalTrials.gov ↗ ← All trials in China