Electrocardiography (ECG), Healthy Volunteers, Photoplethysmography
Conditions
Keywords
ECG, PPG, Wearable device, CardioWatch, Digital Health
Brief summary
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.
Detailed description
Wearable devices have the potential to support continuous physiological monitoring in both clinical and home settings. Although photoplethysmography (PPG) enables comfortable long-term monitoring, it does not directly provide electrocardiographic (ECG) information. This study aims to establish a synchronized dataset of ECG and PPG recordings that can be used to develop and evaluate artificial intelligence algorithms for reconstructing ECG parameters, particularly QT/QTc, from PPG signals. Approximately 50 healthy adult volunteers will be enrolled in this single-center, single-arm observational feasibility study. Participants will wear the Corsano CardioWatch 287-2 together with a reference continuous ECG device for approximately 24 hours. During the study, synchronized recordings will be collected during standardized activities (rest, standing, and light walking) as well as during normal daily activities. The primary endpoints include completeness of paired ECG-PPG recordings, synchronization quality, and the proportion of recordings suitable for QT/QTc annotation. Secondary endpoints include participant comfort and usability of the wearable monitoring system, together with technical performance measures such as signal quality, device connectivity, and data completeness. The resulting dataset will support future development and validation of AI-based methods for ECG parameter reconstruction from wearable PPG signals.
Interventions
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.
DEVICEVivaLNK wearable ECG patch
Continuous reference ECG device used as the gold standard for synchronized ECG recordings and QT/QTc reference annotation
Sponsors
Corsano Health B.V.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Known clotting disorders or current prescription anticoagulant therapy. * Other health conditions preventing safe participation. * Wrist circumference \<14 cm or \>23 cm. * Any participant who, in the investigator's opinion, does not meet study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completeness of paired recordings, synchronisation quality (offset/drift indicators), and proportion of usable segments for QT/QTc reference annotation | 24 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability/comfort of Corsano CardioWatch 287-2 (questionnaire) and technical issue rates (e.g., sensor detachment, connectivity interruptions) | 24 hours | 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 |
Outcome results
None listed