NCT06848179

Brief Summary

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)).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 21, 2025

Last Update Submit

February 21, 2025

Conditions

Keywords

AuscultationSmartphoneHeart SoundsHeart AuscultationPhonocariodgraphy

Outcome Measures

Primary Outcomes (2)

  • HR estimation

    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.

    Day 0

  • HRV estimation

    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.

    Day 0

Secondary Outcomes (1)

  • Participants' comfort level for devices used in this study

    Day 0

Study Arms (1)

Healthy Participants

Participants deemed ready for physical activity by the Physical Activity Readiness Questionnaire (PAR-Q)

Diagnostic Test: Computer algorithmsBehavioral: Exercise

Interventions

Computer algorithmsDIAGNOSTIC_TEST

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

Also known as: ausculto®, Vitogram®
Healthy Participants
ExerciseBEHAVIORAL

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

Healthy Participants

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Apparently healthy volunteers aged 18-69 recruited from the general public

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Joshua Ho, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 26, 2025

Study Start

March 1, 2025

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share