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)).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Joshua Ho, Ph.D.
- Phone Number: +852 3917 9512
- Email: jwkho@hku.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy Participants
Participants deemed ready for physical activity by the Physical Activity Readiness Questionnaire (PAR-Q)
|
Collection of computer algorithms called ausculto® that is designed to perform heart sound analysis to estimate heart rate and heart rate variability
Other Names:
Participants will be requested to exercise to raise their HR over the resting range while heart-related physiological signals are collected.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Day 0
|
|
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.
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Day 0
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AUSC-HR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.