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

Официальное название

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).

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Corsano CardioWatch 287-2
  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.
• Устройство VivaLNK wearable ECG patch
  Continuous reference ECG device used as the gold standard for synchronized ECG recordings and QT/QTc reference annotation

Первичные конечные точки

• Completeness of paired recordings, synchronisation quality (offset/drift indicators), and proportion of usable segments for QT/QTc reference annotation [Срок оценки: 24 hours]

Вторичные конечные точки (1)

• Usability/comfort of Corsano CardioWatch 287-2 (questionnaire) and technical issue rates (e.g., sensor detachment, connectivity interruptions) [Срок оценки: 24 hours]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07684807 · ILECS-ECGPPG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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