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

2026年6月29日 更新者：Corsano Health B.V.

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).

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

50

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
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
设备：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.
设备：VivaLNK wearable ECG patch
Continuous reference ECG device used as the gold standard for synchronized ECG recordings and QT/QTc reference annotation

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Completeness of paired recordings, synchronisation quality (offset/drift indicators), and proportion of usable segments for QT/QTc reference annotation
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Usability/comfort of Corsano CardioWatch 287-2 (questionnaire) and technical issue rates (e.g., sensor detachment, connectivity interruptions)
大体时间：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
24 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Corsano Health B.V.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2026年9月1日

研究完成 (估计的)

2026年10月1日

研究注册日期

首次提交

2026年6月29日

首先提交符合 QC 标准的

2026年6月29日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年6月29日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • ILECS-ECGPPG

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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