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NCT Number: NCT06848179

Smartphone-Based Use of Phonocardiography Technique for Estimating Heart Rate and Heart Rate Variability: Performance Study

This study aims to investigate the use of heart sound recordings, or phonocardiograms, recorded with smartphones' built-in microphones and accessory microphones to estimate heart rate (HR) and heart rate variability (HRV). HR refers to the number of heart beats per minute, while HRV refers to the variation in the intervals between heart beats.

Participants will have their heart sounds (phonocardiograms) recorded before and after exercise, and electrocardiogram (ECG) and photoplethysmogram (PPG) data recorded before, during, and after exercise to induce a wide range of HR.

Researchers will match the phonocardiograms, ECG, and PPG data to create a database for use in future training and testing of algorithms (including artificial intelligence (AI)).

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • With no tattoos on their body where a smartwatch will be placed

Exclusion criteria

  • Not ready to undertake physical activity as assessed by the Physical Activity Readiness Questionnaire (PAR-Q) derived from the Canadian Society for Exercise Physiology
  • Implanted active medical devices in the torso, such as pacemakers and defibrillators
  • Failure to collect baseline heart sound time series from ECG or both smartphone and auscultation pin before exercise

Treatment and study plan

Computer algorithms

Diagnostic Test

Collection of computer algorithms called ausculto® that is designed to perform heart sound analysis to estimate heart rate and heart rate variability

Other names: ausculto®, Vitogram®

Exercise

Behavioral

Participants will be requested to exercise to raise their HR over the resting range while heart-related physiological signals are collected.

Primary outcomes

  1. HR estimation

    Time frame: Day 0

    The algorithm will estimate participants' HR from phonocardiograms at multiple timepoints. The concordance correlation coefficient, mean bias, and limits of agreement will be calculated for HR with ECG-derived HR as the gold standard.

  2. HRV estimation

    Time frame: Day 0

    The algorithm will estimate participants' HRV from phonocardiograms at multiple timepoints. The absolute difference (error) in HRV estimation will be calculated with ECG-derived HRV as the gold standard.

Secondary outcomes

  1. Participants' comfort level for devices used in this study

    Time frame: Day 0

    A survey will be given to participants after heart data collection to evaluate their preferences and comfort level when using the different devices to measure HR and HRV.

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Ho, Ph.D.

CONTACT

[email protected]

+852 3917 9512

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Laboratory of Data Discovery for Health

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2025
Registry last updated
Feb 26, 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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