Back to resultsPediatric Apple Watch Study (PAWS)
Primary Purpose
Arrhythmia in Children
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apple Watch
Sponsored by
About this trial
This is an interventional diagnostic trial for Arrhythmia in Children
Eligibility Criteria
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.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Apple Watch
Arm Description
Participants will wear an Apple Watch for 6 months
Outcomes
Primary Outcome Measures
Heart rate correlation
Comparison of heart rate (bpm) between the Apple Watch and standard clinical rhythm monitor
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
Secondary Outcome Measures
Full Information
NCT ID
NCT06053372
First Posted
September 14, 2023
Last Updated
September 22, 2023
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT06053372
Brief Title
Pediatric Apple Watch Study
Acronym
PAWS
Official Title
Leveraging Wearable Technologies for Arrhythmia Detection in Children - The PAW (Pediatric Apple Watch) Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia in Children
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Apple Watch
Arm Type
Experimental
Arm Description
Participants will wear an Apple Watch for 6 months
Intervention Type
Device
Intervention Name(s)
Apple Watch
Intervention Description
Wearable monitor for heart rate and arrhythmia detection
Primary Outcome Measure Information:
Title
Heart rate correlation
Description
Comparison of heart rate (bpm) between the Apple Watch and standard clinical rhythm monitor
Time Frame
Up to 2 weeks
Title
Arrhythmia correlation
Description
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
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Ceresnak, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pediatric Apple Watch Study
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