Unique ID issued by UMIN | UMIN000041776 |
---|---|
Receipt number | R000047648 |
Scientific Title | Apple Watch Heart Study KEIO Version |
Date of disclosure of the study information | 2021/02/01 |
Last modified on | 2023/03/16 13:56:37 |
Apple Watch Heart Study KEIO Version
- Atrial fibrillation detection by Apple Watch -
Apple Watch Heart Study KEIO Version
Apple Watch Heart Study KEIO Version
AWHS KEIO
Japan |
atrial fibrillation
Cardiology |
Others
NO
To analyze and evaluate pulse rates, irregular heartbeat notifications, and ECG recordings measured by the Apple Watch while subjects are at rest or sleeping in relation to atrial fibrillation events documented by 14-day ECG patch devices.
Others
- To construct and evaluate a machine-learning algorithm to identify the optimal timing of pulse/ECG recording for arrhythmia detection.
- To analyze Apple Watch healthcare data in relation to 14-day ECG patch devices, profile data, questionnaire data, and information from medical records, including data from transtelephonic monitors.
Exploratory
Analysis of the degree of agreement between Apple Watch heart data collected while subjects are at rest or sleeping (pulse rates, irregular heartbeat notifications, and ECG recordings) and 14-day ECG patch data (atrial fibrillation events).
- Construction and evaluation of a machine-learning algorithm to identify the optimal timing of pulse/ECG recording for arrhythmia detection.
- Evaluation of the relevance of Apple Watch healthcare data and 14-day ECG patch data, profile data, questionnaire data, and information from medical records, including data from transtelephonic monitors.
Observational
20 | years-old | < |
Not applicable |
Male and Female
- Is an atrial fibrillation patient receiving treatment at the Department of Cardiology, KEIO University Hospital.
- Aged >= 20 years (no gender restrictions).
- Has access to an iPhone (iOS > 13.0) and Apple Watch (watchOS > 6.0) and can download the research application from the App Store (Japan) (iPhone and Apple Watch can be borrowed).
- Is a Japanese person who can understand Japanese.
- Is capable of understanding the content of this study and giving his/her written consent.
- Is unable to wear an Apple Watch while sleeping.
- Is unable to operate the research application.
- Is scheduled to be transferred or moved.
- Has been deemed an inappropriate subject by the research supervisor or office.
100
1st name | Masahiro |
Middle name | |
Last name | Jinzaki |
Keio University School of Medicine
Department of Radiology
160-8582
35 Shinanomachi Shinjuku-ku, Tokyo
03-5363-3836
jinzaki@rad.med.keio.ac.jp
1st name | Takehiro |
Middle name | |
Last name | Kimura |
Keio University School of Medicine
Department of Cardiology
160-8582
35 Shinanomachi Shinjuku-ku, Tokyo
03-5843-6703
awhs-group@keio.jp
Keio University Hospital
Biosense Webster Inc.
Outside Japan
Keio University School of Medicine Ethics Committee
35 Shinanomachi Shinjuku-ku, Tokyo
03-3353-1211 (62014)
med-rinri-jimu@adst.keio.ac.jp
NO
2021 | Year | 02 | Month | 01 | Day |
Partially published
100
Completed
2020 | Year | 07 | Month | 17 | Day |
2020 | Year | 10 | Month | 29 | Day |
2021 | Year | 01 | Month | 12 | Day |
2025 | Year | 08 | Month | 31 | Day |
Informed consent will be obtained through a written form and the research application. The participants will be instructed to wear the Apple Watch while at rest and while sleeping, wear a 14-day ECG patch device, answer the questionnaire, and record an ECG twice daily and while experiencing symptoms. The healthcare data and answers will be collected using the research application. The observation period will be 14 consecutive days.
2020 | Year | 09 | Month | 13 | Day |
2023 | Year | 03 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047648
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