Pediatric Apple Watch Study

Arrhythmia in Children Clinical Trial

— PAWS  

Official title:

Leveraging Wearable Technologies for Arrhythmia Detection in Children - The PAW (Pediatric Apple Watch) Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06053372
• Other study ID #: 67366
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: February 2025

Study information

• Verified date: December 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Specific Aim #1 - To determine the accuracy of Apple Watch ECG tracings heart rate in children.

Specific Aim #2 - To determine if extended monitoring with the Apple Watch can identify arrhythmia events that were not detected by short term clinical monitoring.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 21 Years

Eligibility

Inclusion Criteria:

• All pediatric patients age 6 - 21 years undergoing clinically indicated arrhythmia monitoring

• Patients with developmental ability (as determined by patient and parents) to safely wear the Apple Watch and utilize the patient activated trigger buttons on both the clinical monitor and the Apple Watch.

Exclusion Criteria:

• Age < 6 years. Those under 6 many not be able to safely use the watch and have the developmental ability (as gauged by clinician and parents) to utilize the trigger features on the watch and cardiac rhythm monitor.

• Inability to effectively utilize the triggered features of the monitor or watch

• Patients unable to utilize the Apple Watch.

Related Conditions & MeSH terms

• Arrhythmia in Children
• Arrhythmias, Cardiac

Intervention

Device:
• Apple Watch
Wearable monitor for heart rate and arrhythmia detection

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate correlation	Comparison of heart rate (bpm) between the Apple Watch and standard clinical rhythm monitor	Up to 2 weeks
Primary	Arrhythmia correlation	Comparison of the number of clinically significant arrhythmia events between the Apple Watch and standard clinical rhythm monitor. Clinically significant arrhythmia events include supraventricular arrhythmias, ventricular arrhythmias, sinus pauses, and conduction abnormalities/heart block	Up to 6 months