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).
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Completeness of paired recordings, synchronisation quality (offset/drift indicators), and proportion of usable segments for QT/QTc reference annotation
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Usability/comfort of Corsano CardioWatch 287-2 (questionnaire) and technical issue rates (e.g., sensor detachment, connectivity interruptions)
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- ILECS-ECGPPG
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。