CompletedNot Applicable

WHOOP Abnormal Rhythm Notification

United States653 participantsStarted 2023-04-10

Plain-language 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.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

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

Trial details

NCT IDNCT05809362

SponsorYale University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-25

View on ClinicalTrials.gov More Atrial Fibrillation trials

Plain-language summary

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

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