EpiWatch: Evaluation of a Non-EEG Physiological Signal Based Seizure Monitoring System

EpiWatch, Inc.242 enrolled

Overview

To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review, during patient hospitalization in an epilepsy monitoring unit (EMU). Eligible subjects will be issued an EpiWatch device upon admittance into the EMU. The events detected by the EpiWatch will be compared to TC seizures as determined by epileptologists' interpretation of video-EEG recorded for the subject to determine the effectiveness of EpiWatch in detecting TC seizures. EMU standard care practices will not be modified for subjects.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

242

Conditions

Epilepsy, Tonic-Clonic

Interventions

Physiological signal monitoring and seizure detectionDEVICE

Data collection and as an adjunct to other methods of seizure monitoring

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Admitted to a site EMU for video-EEG monitoring * Age five and older at the time of enrollment * Has a clinical history of tonic-clonic (TC) seizures or potential for TC seizures * Willing and able to comply with study procedures Exclusion Criteria: * Has participated previously in EpiWatch development studies or contributed any data to the prior development or evaluation of the detector being tested or previous detectors * Has any condition that would prevent proper wearing of the watch, its free movement during a seizure, or create discomfort from wearing the watch * Inability or unwillingness to comply with study procedures

Locations (1)

Johns Hopkins Medicine

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Comparison of video-EEG to EpiWatch Results for PPA

Lower bound of 95% confidence interval of the positive percent agreement (PPA) \> 80%, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.

Time frame: 6 months

Comparison of video-EEG to EpiWatch results for FAR

Upper bound of 95% confidence interval of the false alarm rate (FAR) \<.71, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers.

Time frame: 6 months

Secondary Outcomes

Pediatric Ambulation Positive Percent Agreement

Estimate the PPA in pediatric participants in ambulation in addition to at rest

Time frame: 6 months

Pediatric Ambulation False Alarm Rate

Estimate the False Alarm Rate in pediatric participants in ambulation in addition to rest

Time frame: 6 months

Data from ClinicalTrials.gov

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