Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT07154303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing the Performance of Smartphones and Their Accessories in Detecting Irregularly Irregular Heart Rhythm
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
Smartphone-Based Use of Phonocardiography, Electrocardiography Accessory, and/or Facial Photoplethysmography to Detect Atrial Fibrillation: Diagnostic Performance Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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.
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.
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UW 24-763 | OTHER | Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster | View |