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Completed

NCT Number: NCT05059002

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

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).

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Key information

Conditions

Epilepsy, Tonic-Clonic Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Generalized Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Medicine

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiological signal monitoring and seizure detection

Device

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

Primary outcomes

  1. Comparison of video-EEG to EpiWatch Results for PPA

    Time frame: 6 months

    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.

  2. Comparison of video-EEG to EpiWatch results for FAR

    Time frame: 6 months

    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.

Secondary outcomes

  1. Pediatric Ambulation Positive Percent Agreement

    Time frame: 6 months

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

  2. Pediatric Ambulation False Alarm Rate

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

EpiWatch, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2021
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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