Synchronised ECG and PPG Data Collection for AI-based QT/QTc Reconstruction (ILECS-ECGPPG)

ConditionsElectrocardiography (ECG)Photoplethysmography Healthy Volunteers

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorCorsano Health B.V.

About this trial

This observational study will collect synchronized photoplethysmography (PPG) and electrocardiogram (ECG) recordings from approximately 50 healthy adult volunteers. Participants will wear the Corsano CardioWatch 297-2 and a reference ECG device simultaneously for approximately 24 hours, including standardized activities and free-lining conditions. The objective is to generate a high-quality paired ECG-PPG dataset to support the development and evaluation of artificial intelligence methods fro reconstructing ECG parameters, with a particular focus on QT/QTc, from PPG signals. The study will also evaluate the feasibility and usability of the wearable monitoring system.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able to provide written informed consent.

Willing and able to comply with all study procedures and attend the required study visits.

Age ≥18 years.

Able to read or understand Dutch or English.

Disqualifiers

Children/minors or vulnerable individuals.

Skin conditions or allergies preventing safe wear of the CardioWatch or ECG electrodes.

Any condition that, in the investigator's opinion, may interfere with study completion or data quality.

Compromised circulation, injury, or physical malformation at sensor sites.

Trial population

Healthy adult volunteers, including hospital employees, recruited at a single clinical site.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Corsano CardioWatch 287-2
Device
Wrist-worn wearable device used to collect continuous photoplethysmography (PPG) signals and related physiological data during the study. The device is used simultaneously with a reference ECG device to generate synchronized ECG-PPG datasets for AI algorithm development and evaluation.
VivaLNK wearable ECG patch
Device
Continuous reference ECG device used as the gold standard for synchronized ECG recordings and QT/QTc reference annotation

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Healthy adult volunteers2 interventions

Trial outcomes

Primary outcomes

Completeness of paired recordings, synchronisation quality (offset/drift indicators), and proportion of usable segments for QT/QTc reference annotation

Assessment of paired ECG-PPG recording completeness, synchronization quality using offset and drift indicators, and the proportion of usable segments for QT/QTc reference annotation

Time frame

24 hours

Secondary outcomes

Usability/comfort of Corsano CardioWatch 287-2 (questionnaire) and technical issue rates (e.g., sensor detachment, connectivity interruptions)

Assessment of participant-reported usability and comfort of the Corsano CardioWatch 287-2 using a questionnaire, together with the frequency and type of technical issues affecting data collection, including sensor detachment, connectivity interruptions, and other technical problems encountered during the study

Time frame

24 hours

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corsano Health B.V.

Lead sponsor

Source ClinicalTrials.gov

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