Pediatric Apple Watch Study
Not Applicable
- Conditions
- Arrhythmia in Children
- Interventions
- Device: Apple Watch
- Registration Number
- NCT06053372
- Lead Sponsor
- Stanford University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Apple Watch Apple Watch Participants will wear an Apple Watch for 6 months
- Primary Outcome Measures
Name Time Method Heart rate correlation Up to 2 weeks Comparison of heart rate (bpm) between the Apple Watch and standard clinical rhythm monitor
Arrhythmia correlation Up to 6 months 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Stanford University
🇺🇸Palo Alto, California, United States