Pediatric Apple Watch Study | NCT06053372

Studies
Pediatric Apple Watch Study

NCT06053372

Sponsor

Stanford University

Status

Enrolling by invitation

Last Update Posted

Aug 21, 2024Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Arrhythmia in Children

Interventions

Apple Watch

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 16, 2024Actual

Primary Completion Date

Aug 2025Estimated

Completion Date

Mar 2026Estimated

First Submitted Date

Sep 14, 2023

First Submission Date that Met QC Criteria

Sep 22, 2023

First Posted Date

Sep 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2024

Last Update Posted Date

Aug 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Apple Watch	Experimental	Participants will wear an Apple Watch for 6 months	Device: Apple Watch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Apple Watch	Device	Wearable monitor for heart rate and arrhythmia detection	Apple Watch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart rate correlation	Comparison of heart rate (bpm) between the Apple Watch and standard clinical rhythm monitor	Up to 2 weeks
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Scott Ceresnak, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Palo Alto	California	94306	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided