WHOOP Abnormal Rhythm Notification

NCT ID: NCT05809362

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 653 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2024-01-25

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.

Detailed Description

Atrial fibrillation (Afib) is the most common cardiac arrhythmia in the United States, affecting up to one in four individuals across the lifespan, and is associated with substantial morbidity and mortality. Fifteen percent of strokes in the United States are attributable to Afib, and nearly 20% of these occur in individuals with no prior Afib history. Because Afib is often paroxysmal, one-time screening is unlikely to capture those at risk. Thus, there has been an increasing interest in leveraging monitoring for Afib via wearable devices, which provide a novel method to detect Afib and determine the burden of Afib in the general population. Devices such as the WHOOP 4.0 strap use advanced sensors to detect pulse rate and other physiologic metrics in real-time. Given the high degree of pulse-rate variability in Afib, it is clear that algorithms evaluating data from these devices may be able to detect asymptomatic Afib. However, the sensitivity and specificity of the algorithm operating on data from the WHOOP 4.0 strap have not been formally evaluated in a clinical setting.

The WHOOP strap measures changes in blood flow via photoplethysmography (PPG), from which timing between successive heartbeats ("beat-to-beat intervals") is measured. While normal sinus rhythm tends to display beat-to-beat intervals of similar magnitude, those of cardiac arrythmias are characterized by higher variability and may follow particular patterns.

The primary objective of this study is to assess the sensitivity and specificity of the WHOOP Strap ANF 1.0 classification algorithm for the detection of Afib as compared to a gold-standard assessment (one-week ECG patch monitoring using the BioTel ePatch).

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Atrial Fibrillation

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

WHOOP 4.0 Strap

Intervention Type: 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.

BioTel ePatch

Intervention Type: 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.

No atrial fibrillation

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

WHOOP 4.0 Strap

Intervention Type: 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.

BioTel ePatch

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• Subjects taking rhythm control drugs including amiodarone, dronedarone, dofetilide, sotalol, flecainide, ibutilide, lidocaine, procainamide, propafenone, quinidine, tocainide.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Whoop Inc.

INDUSTRY

Sponsor Role: collaborator

ZS Associates, Inc.

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Francis P. Wilson

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francis P Wilson, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38830741 (View on PubMed)

Other Identifiers

2000031382

Identifier Type: -

Identifier Source: org_study_id