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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07154303
Enrollment
209
Registered
2025-09-04
Start date
2025-08-27
Completion date
2026-10-31
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

Keywords

Smartphone, Persistent Atrial Fibrillation, Mobile Health, mHealth, Telemedicine, Artificial Intelligence, Heart Sounds, Phonocardiography, Photoplethysmography, Electrocardiography, 12-Lead ECG, 12-Lead EKG, 12-Lead Electrocardiography, ECG, EKG, Electrocardiogram, Electrocardiograph

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 (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.

Interventions

DIAGNOSTIC_TESTComputer 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.

Sponsors

Laboratory of Data Discovery for Health
CollaboratorUNKNOWN
The University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum

Inclusion criteria

* Age: ≥22 years (adult) * Patients who have one of the following: * Permanent atrial fibrillation, or * Long-standing persistent atrial fibrillation (12 months or longer), or * Confirmed 12-lead ECG diagnosis for persistent atrial fibrillation (\> 7 days) or sinus rhythm within 12 months at the time of their normal attendance at the hospital

Exclusion criteria

Any of the following: * Implanted active medical devices in the torso, such as pacemakers and defibrillators * Patients without atrial fibrillation who have another arrhythmia * Completely missing one or more limbs, or missing any hand * Disability in using their hands or arms * Lack of both index fingers, or all fingers in any hand * Both index fingers with any of the following characteristics: * Tattooed/inked * Reduced blood flow in the fingertip (e.g. perniosis or callus formation)

Design outcomes

Primary

MeasureTime frameDescription
Differentiation of Atrial Fibrillation from Sinus Rhythm in Heart Sound RecordingsDay 0AUSC-AF: Identification of atrial fibrillation (AF) from sinus rhythm in recorded heart sounds (phonocardiogram \[PCG\]) as verified by the gold standard 12-lead electrocardiography (ECG) interpretation, measured in the form of sensitivity and specificity.

Secondary

MeasureTime frameDescription
Differentiation of Atrial Fibrillation from Sinus Rhythm in Heart Sound RecordingsDay 0AUSC-AF: Identification of atrial fibrillation from sinus rhythm in recorded heart sounds (phonocardiogram \[PCG\]) as verified by the gold standard 12-lead ECG interpretation, measured in the form of positive and negative predictive values, and accuracy.
Differentiation of Atrial Fibrillation from Sinus Rhythm in 1-Lead ECG SignalsDay 0ECG-AF: Identification of atrial fibrillation from sinus rhythm in recorded 1-lead ECG signals as verified by the gold standard 12-lead ECG interpretation, measured in the form of sensitivity, specificity, positive and negative predictive values, and accuracy.
Differentiation of Atrial Fibrillation from Sinus Rhythm in PCG and 1-Lead ECG SignalsDay 0AUSC+ECG-AF: Identification of atrial fibrillation from sinus rhythm in PCG and 1-lead ECG signals as verified by the gold standard 12-lead ECG interpretation, measured in the form of sensitivity, specificity, positive and negative predictive values, and accuracy.
Differentiation of Atrial Fibrillation from Sinus Rhythm in Facial Photoplethysmography SignalsDay 0rPPG-AF: Identification of atrial fibrillation from sinus rhythm in facial photoplethysmography signals (also known as remote photoplethysmography \[rPPG\]) as verified by the gold standard 12-lead ECG interpretation, measured in the form of sensitivity, specificity, positive and negative predictive values, and accuracy.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026