WHOOP Abnormal Rhythm Notification
NCT05809362 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 653
Last updated 2024-04-23
Summary
The purpose of this protocol is to assess the sensitivity and specificity of a photoplethysmography (PPG)-based algorithm for the detection of atrial fibrillation as compared to a gold-standard assessment (wearable ECG patch) among a population of individuals with known atrial fibrillation and without known atrial fibrillation over a 7-day study period.
Conditions
Interventions
- DEVICE
-
WHOOP 4.0 Strap
Subjects will receive both the WHOOP 4.0 Strap and the BioTel ePatch and will continuously wear each for one week. Data will be collected and analyzed by the study team upon return of the both devices from the subject.
- DEVICE
-
BioTel ePatch
Subjects will receive both the WHOOP 4.0 Strap and the BioTel ePatch and will continuously wear each for one week. Data will be collected and analyzed by the study team upon return of the both devices from the subject.
Sponsors & Collaborators
-
Whoop Inc.
collaborator INDUSTRY -
ZS Associates, Inc.
collaborator UNKNOWN -
Yale University
lead OTHER
Principal Investigators
-
Francis P Wilson, MD MSCE · Yale University
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-04-10
- Primary Completion
- 2024-01-25
- Completion
- 2024-01-25
- FDA Device
- Yes
Countries
- United States
Study Locations
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