NCT05809362

WHOOP Abnormal Rhythm Notification

Validation of a Photoplethysmography-Based Algorithm for Detection of Atrial Fibrillation Via a Wearable Device - WHOOP Abnormal Rhythm Notification

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 653 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-10
• Primary completion: 2024-01-25
• Completion: 2024-01-25
• First posted: 2023-04-12
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study