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

EpiWatch, Inc.

Status: Completed

Conditions: Epilepsy, Tonic-Clonic

Treatments: Device: Physiological signal monitoring and seizure detection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05059002

EPW001

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 242 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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242 participants in 1 patient group

Monitored Subjects

Other group

Description:

Single arm study of subjects that have been issued an EpIWatch

Treatment:

Device: Physiological signal monitoring and seizure detection