WHOOP Abnormal Rhythm Notification

NCT05809362 | Completed FDA Device

• 1 other identifier: 2000031382
• Study Type: observational
• Target: 653
• Locations: 1 country
• Sites: 1

Brief 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

Atrial Fibrillation

Keywords

Atrial fibrillation; Wearable device

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the PPG-based WHOOP ANF algorithm for detection of atrial fibrillation

  Sensitivity is defined as the True Positives/(True Positives + False Negatives). A "true" atrial fibrillation reading will have an ECG patch reading consistent with sustained atrial fibrillation for at least 5 continuous minutes. A WHOOP ANF diagnosis of atrial fibrillation is defined as "atrial fibrillations" being detected using the internal algorithm. A true positive is defined as the count of individuals who have at least 1 window labelled as Afib by WHOOP ANF and which has 5+ minutes of continuous Afib as determined by the BioTel recording and confirmed by tachogram adjudication. A false negative is defined as individuals who do not have any windows labelled by WHOOP-ANF as having Afib but at least one window has 5+ minutes of continuous Afib as determined by the BioTel recording.

  7 days of continuous wear of the WHOOP 4.0 Strap and BioTel ePatch immediately post enrollment

• Specificity of the PPG-based WHOOP ANF algorithm for detection of atrial fibrillation

  Specificity is defined as the True Negatives/(True Negatives + False Positives). A "true" atrial fibrillation reading will have an ECG patch reading consistent with sustained atrial fibrillation for at least 5 continuous minutes. A WHOOP ANF diagnosis of atrial fibrillation is defined as "atrial fibrillations" being detected using the internal algorithm. A true negative is defined as the count of individuals who do not have any windows labelled by WHOOP ANF as having Afib and none of these windows contain 5+ minutes of continuous Afib as determined by the BioTel recording. A false positive is defined as individuals who have windows labelled as Afib by WHOOP ANF but none of these windows contain 5 minutes or greater of continuous Afib as determined by BioTel recording or have 5+ minutes of continuous Afib as determined by BioTel recording but none can be verified by tachogram adjudication.

  7 days of continuous wear of the WHOOP 4.0 Strap and BioTel ePatch immediately post enrollment

Secondary Outcomes (1)

• Concordance between WHOOP ANF and BioTel ePatch via epoch assessment

  7 days of continuous wear of the WHOOP 4.0 Strap and BioTel ePatch immediately post enrollment

Study Arms (2)

Atrial Fibrillation

Subjects with known diagnosis of atrial fibrillation (persistent or paroxysmal) documented in the medical record.

Device: WHOOP 4.0 Strap; Device: BioTel ePatch

No atrial fibrillation

Subjects with no known diagnosis of atrial fibrillation as documented in the medical record.

Device: WHOOP 4.0 Strap; Device: BioTel ePatch

Interventions

WHOOP 4.0 Strap DEVICE

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.

Atrial Fibrillation; No atrial fibrillation

BioTel ePatch DEVICE

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.

Atrial Fibrillation; No atrial fibrillation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include adults seen in primary care and cardiology clinics associated with a single health system. The prospective cohort will comprise three distinct populations - individuals with a known history of persistent atrial fibrillation, individuals with paroxysmal atrial fibrillation, and individuals without a history of cardiac arrhythmia of any kind.

You may qualify if:

• Age \>= 22 years
• Known diagnosis of atrial fibrillation OR no history of arrhythmia as documented in the patient medical record
• Seen in a Yale New Haven Hospital-associated Primary Care or Cardiology Clinic
• Cell phone (IOS 15.0 or greater or Android 10 or greater) with an active data plan and willing to install the WHOOP Mobile Application software
• Full-time US resident
• Able to read, understand, and provide written informed consent in English
• Willing and able to participate in the study procedures as described in the consent form
• Able to communicate effectively with and follow instructions from the study staff

You may not qualify if:

• Pre-existing WHOOP user with active account
• Has implantable cardiac device (e.g., pacemaker, ICD, LVAD)
• Solid organ transplant
• Sensitivity or allergy to ECG patch or skin glue
• Unwilling to wear WHOOP 4.0 strap for one week
• Unwilling to wear BioTel (ECG patch) ePatch for one week
• WHOOP strap should be the only wearable on the arm. Individuals unwilling to adhere to the proper usage of the WHOOP strap will be excluded.
• Unwilling to install the WHOOP Mobile Application software
• Unable to provide informed consent
• Non-English speaking (as the WHOOP Mobile Application software is English only)
• Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to polyamide, polyester, or elastane bands primarily used in wrist worn fitness devices
• Symptomatic (or active) allergic skin reactions
• Significant tremor that prevents the subject from being able to hold still.
• Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the investigator, increases the risk to the subject or renders data uninterpretable.
• Pregnant women: Women who report being pregnant at the time of study participation.

Sponsors & Collaborators

• Yale University: lead
• Whoop Inc.: collaborator
• ZS Associates, Inc.: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• Kumar S, Weinstein J, Melchinger HC, Smith A, Capodilupo E, Akar JG, Garg K, O'Connor KD, Staunton MK, Martin M, Akhlaghi N, Edeh O, Perez S, Lee V, Lee KAV, Wilson FP. Observational study protocol for an arrhythmia notification feature. BMJ Open. 2024 Jun 3;14(6):e075110. doi: 10.1136/bmjopen-2023-075110.

  PMID: 38830741 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francis P Wilson, MD MSCE

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 12, 2023
• Study Start: April 10, 2023
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)