NCT07154303

Testing the Performance of Smartphones and Their Accessories in Detecting Irregularly Irregular Heart Rhythm

Smartphone-Based Use of Phonocardiography, Electrocardiography Accessory, and/or Facial Photoplethysmography to Detect Atrial Fibrillation: Diagnostic Performance Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 209 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: —

Summary

The purpose of this 4-in-1 observational study is to test the performance of artificial intelligences (AIs) in distinguishing irregularly irregular heart rhythm called atrial fibrillation (AF) from normal heart rhythm using physiological signals collected by smartphones' built-in hardware and/or external accessories. Participants will: * Have their weight, height, resting heart rate and blood pressures measured * Have 12-lead electrocardiogram (ECG) of their heart electrical activities recorded * Have their heart sounds and 1-lead ECG recorded from their chest, and optical-based blood flow data (photoplethysmography or PPG) and 1-lead ECG recorded from their fingers using smartphones' built-in microphone, camera, and/or external accessories * Optionally have their optical-based blood flow data recorded from their face using smartphones' built-in camera (remote PPG or rPPG). The researchers will also create a database containing the physiological signals collected in this study along with the participants' medically relevant information to help train and test future AIs for medical applications.

Detailed description

4 observational studies have been combined into 1 observational study to share the same pool of participants. These 4 studies are designated as AUSC-AF, ECG-AF, AUSC+ECG-AF, and rPPG-AF corresponding to the signal modality/modalities used for AF detection (see outcome measures) and designated as AUSC/ECG/rPPG-AF when combined as 1 study.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Computer algorithms	Computer algorithms that are designed to perform heart sound, electrocardiography (ECG), and/or facial photoplethysmography (rPPG) analysis on data collected from smartphone's internal hardware and/or external accessories.

Timeline

• Start date: 2025-08-27
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2025-09-04
• Last updated: 2025-12-31

Locations

1 site across 1 country: China