Atrial FibrillationWARNNCT05809362
WHOOP Abnormal Rhythm Notification
An observational study of Atrial Fibrillation, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- WHOOP 4.0 Strap and BioTel ePatch
- Type of treatment
- Medical device
- How many people
- 653 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 25 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Photoplethysmography-Based Algorithm for Detection of Atrial Fibrillation Via a Wearable Device - WHOOP Abnormal Rhythm Notification
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.
Read the 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
- Being tested
- WHOOP 4.0 Strap, BioTel ePatch
- Keywords
- Atrial fibrillation, Wearable device
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHOOP 4.0 StrapDevice
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 ePatchDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation | Subjects with known diagnosis of atrial fibrillation (persistent or paroxysmal) documented in the medical record. Receives: 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. Receives: Device: WHOOP 4.0 Strap; Device: BioTel ePatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Comparison of each epoch by both WHOOP ANF and the BioTel ePatch for concordance using the following definitions: True Positive: An epoch detected by WHOOP ANF as "atrial fibrillation" that has >=5 mins of AFib as detected by the ECG patch. True Negative: An epoch that is NOT labelled as "atrial fibrillation" by the WHOOP ANF and has < 5 mins of AFib as detected by the ECG patch. Specificity of the algorithm on the epoch level: True Negative/(True Negatives + False Positives). Sensitivity of the algorithm on the epoch level: True Positives / (True Positives + False Negatives). Positive predictive value of the algorithm on the epoch level: True Positives / (True Positives + False Positives). Negative predictive value of the algorithm on the epoch level: True Negatives / (True Negatives + False Negatives).
Measured: 7 days of continuous wear of the WHOOP 4.0 Strap and BioTel ePatch immediately post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start10 Apr 2023
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Whoop Inc., ZS Associates, Inc.
- Responsible party
- Principal investigator, Francis P. Wilson, Yale University
- Investigators
- Francis P Wilson, MD MSCE, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809362
- Sponsor's protocol ID
- 2000031382
- Acronym
- WARN
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38830741
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Photoplethysmography-Based Algorithm for Detection of Atrial Fibrillation Via a Wearable Device - WHOOP Abnormal Rhythm Notification
- ClinicalTrials.gov ID
- NCT05809362
- Acronym / sponsor ID
- WARN / 2000031382
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Wearable device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 653 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Whoop Inc., ZS Associates, Inc.
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation | – | Device: WHOOP 4.0 Strap, Device: BioTel ePatchSubjects with known diagnosis of atrial fibrillation (persistent or paroxysmal) documented in the medical record. |
| No atrial fibrillation | – | Device: WHOOP 4.0 Strap, Device: BioTel ePatchSubjects with no known diagnosis of atrial fibrillation as documented in the medical record. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHOOP 4.0 StrapSubjects 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 | Atrial Fibrillation, No atrial fibrillation |
| BioTel ePatchSubjects 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 | Atrial Fibrillation, No atrial fibrillation |
Primary outcome
Sensitivity of the PPG-based WHOOP ANF algorithm for detection of atrial fibrillation
Time frame: 7 days of continuous wear of the WHOOP 4.0 Strap and BioTel ePatch immediately post enrollment
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.
Specificity of the PPG-based WHOOP ANF algorithm for detection of atrial fibrillation
Time frame: 7 days of continuous wear of the WHOOP 4.0 Strap and BioTel ePatch immediately post enrollment
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.
1 secondary outcome
Concordance between WHOOP ANF and BioTel ePatch via epoch assessment
Time frame: 7 days of continuous wear of the WHOOP 4.0 Strap and BioTel ePatch immediately post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 38830741Kumar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis P Wilson, MD MSCE principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the PPG-based WHOOP ANF algorithm for detection of atrial fibrillation (time frame: 7 days of continuous wear of the WHOOP 4.0 Strap and BioTel ePatch immediately post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.