Apple Watch for Pediatric Arrhythmia

(PAWS Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Age < 6, Developmental ability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Apple Watch's ability to track heart rhythms in children. Researchers aim to determine if the watch can detect heart problems that short-term medical tests might overlook. Children aged 6 to 21, already under evaluation for heart rhythm issues and able to use the watch features, may qualify. Participants will wear the watch for six months to identify any missed arrhythmia events. As an unphased trial, this study allows participants to contribute to innovative research that could enhance heart monitoring for children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring heart rhythms with the Apple Watch, so you may not need to change your medication routine.

What prior data suggests that the Apple Watch is safe for pediatric use?

Research has shown that the Apple Watch is safe for children to use for checking heart rhythms. Studies have found that it accurately tracks heart activity without causing harm. Already used to detect heart issues like atrial fibrillation (an irregular heartbeat) in adults, the Apple Watch has a strong safety record. It can also accurately measure other important health indicators, such as oxygen levels, in children. No major reports of problems from wearing the watch have emerged, suggesting it is well-tolerated by children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Apple Watch for pediatric arrhythmia because it offers a non-invasive, continuous monitoring solution that is more accessible and user-friendly than traditional equipment like Holter monitors. Unlike standard treatments that require occasional check-ups and bulky devices, the Apple Watch provides real-time data, allowing for immediate detection and response to irregular heart rhythms. This wearable technology empowers children and their families with more control and peace of mind, potentially leading to earlier interventions and better management of the condition.

What evidence suggests that the Apple Watch is effective for detecting pediatric arrhythmia?

Research has shown that the Apple Watch, which participants in this trial will wear, can effectively detect irregular heartbeats in children, with 71% of patients having confirmed irregularities. Studies also indicate that the heart rate readings from the Apple Watch closely match those from traditional ECGs, standard heart tests. However, the Apple Watch is less reliable at automatically identifying heart rhythm issues in children compared to adults. Additionally, the watch has proven helpful in checking for QT interval prolongation, a heart rhythm condition, in young patients. Despite some limitations, the Apple Watch shows promise in spotting heart problems that might be missed with short-term clinical monitoring. ^{1 2 6 7 8}

Who Is on the Research Team?

Scott Ceresnak, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 6 to 21 who are undergoing monitoring for heart rhythm problems. Participants must be able to wear an Apple Watch safely and use its features, including the trigger buttons.

Inclusion Criteria

I can safely use an Apple Watch and its buttons.

I am between 6 and 21 years old and need heart rhythm monitoring.

Exclusion Criteria

I cannot use an Apple Watch.

I am under 6 years old.

You are unable to use the monitor or watch's special features effectively.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will wear an Apple Watch to monitor heart rate and detect arrhythmias

6 months

Initial setup visit (in-person), periodic virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Apple Watch

Trial Overview The study aims to test how accurately the Apple Watch can record ECG tracings and heart rate in kids. It also looks at whether using the watch longer term catches any arrhythmias that shorter clinical tests might miss.

How Is the Trial Designed?

Group I: Apple Watch Experimental Treatment 1 Intervention

Participants will wear an Apple Watch for 6 months

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10719318/

Utility of smart watches for identifying arrhythmias in children We show that the Apple Watch is able to capture clinical arrhythmia events in children, and for many patients with confirmed arrhythmia (71 ...

2. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2023.1185629/full

Development of an AI based automated analysis ... In contrast to adults, though, the automatic heart rhythm classification of the Apple Watch did not provide satisfactory results in children.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352906723000635

Detection of QT interval prolongation using Apple Watch ... This study aimed to determine its usefulness for assessment of prolongation of QTc interval in children and adolescents with long QT syndrome (LQTS).

4. acc.org acc.org/Latest-in-Cardiology/Articles/2024/05/29/16/56/Smartwatches-and-Atrial-Fibrillation

Smartwatches and Atrial Fibrillation: What Works and What ... This expert analysis reviews several common consumer-grade devices, their specificity for detecting atrial fibrillation (AF), and the limitations of their use.

5. dovepress.com dovepress.com/accuracy-of-apple-watch-in-measuring-30-second-resting-electrocardiogr-peer-reviewed-fulltext-article-JMDH

Accuracy of Apple Watch in Measuring 30-Second Resting ... Our results also showed that HR measured from the Apple Watch for 30 seconds, and by 12-lead ECG, had a strongly positive correlation in cardiac ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10286860/

Development of an AI based automated analysis ... The Apple Watch valuably records event-based electrocardiograms (iECG) in children, as shown in recent studies by Paech et al.

7. nature.com nature.com/articles/s41598-024-84459-0

The use of Apple smartwatches to obtain vital signs ... The study concluded that the Apple smartwatch series 6 is accurate enough for measuring oxygen saturation in the pediatric population. In the ...

8. apple.com apple.com/healthcare/docs/site/Apple_Watch_Arrhythmia_Detection.pdf

Using Apple Watch for Arrhythmia Detection Apple Watch customers have access to two software as medical device features to detect heart arrhythmias such as atrial fibrillation (AFib): the Irregular ...