Synchronised ECG and PPG Data Collection for AI-based QT/QTc Reconstruction (ILECS-ECGPPG) (ILECS-ECGPPG)
Collection of Synchronised ECG and PPG Recordings in Healthy Adult Volunteers to Develop and Evaluate AI Methods for ECG- Parameter Reconstruction From PPG (Focus: QT/QTc).
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Healthy adult volunteers
Approximately 50 healthy adult volunteers who will wear the Corsano CardioWatch 287-2 and a reference ECG device simultaneously for approximately 24 hours, including standardized activities and free-living monitoring, to collect synchronized ECG and PPG recordings
|
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.
Continuous reference ECG device used as the gold standard for synchronized ECG recordings and QT/QTc reference annotation
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Completeness of paired recordings, synchronisation quality (offset/drift indicators), and proportion of usable segments for QT/QTc reference annotation
Periodo de tiempo: 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
|
24 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Usability/comfort of Corsano CardioWatch 287-2 (questionnaire) and technical issue rates (e.g., sensor detachment, connectivity interruptions)
Periodo de tiempo: 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
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24 hours
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- ILECS-ECGPPG
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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