Pediatric Apple Watch Study

NCT ID: NCT06053372

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-16

Study Completion Date

2026-03-31

Brief Summary

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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

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Conditions

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Arrhythmia in Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Apple Watch

Participants will wear an Apple Watch for 6 months

Group Type EXPERIMENTAL

Apple Watch

Intervention Type DEVICE

Wearable monitor for heart rate and arrhythmia detection

Interventions

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Apple Watch

Wearable monitor for heart rate and arrhythmia detection

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Scott Ceresnak

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott Ceresnak, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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67366

Identifier Type: -

Identifier Source: org_study_id

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