WHOOP Abnormal Rhythm Notification

NCT05809362 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 653

Last updated 2024-04-23

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05809362 on ClinicalTrials.gov