Generalized Seizure Detection And Alerting In The EMU With The Empatica Embrace Watch And Smartphone-Based Alert System

Not Applicable

• Conditions: Epilepsy
• Interventions: Device: Additional Seizure Monitoring

• Registration Number: NCT03207685
• Lead Sponsor: Empatica, Inc.

Brief Summary

To demonstrate safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU).

Detailed Description

To demonstrate safety and effectiveness of the Embrace device in identifying convulsive seizures (CS) and notifying a caregiver during patient hospitalization at an epilepsy monitoring unit (EMU).

Subjects will be fit with an Embrace device upon admittance into the EMU. The Embrace system will be used in conjunction with the EMU standard care practices to monitor the subject during the subject's stay. EMU standard care practices will not be impacted by the Embrace system, but rather the Embrace will be used to supplement the EMU monitoring. The events detected by Embrace will later be compared to the gold standard results of the video EEG.

A convulsive seizure (CS) is defined for the purpose of this study as any seizure with non-facial motor activity involving one or both upper and/or lower extremities that has repetitive motor activity (rhythmic motor movements).

Study Timeline

• Study First Submitted: 2017-06-29
• Study Start: 2017-06-30
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-05
• Primary Completion: 2019-01-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Male and female patients with a history of convulsive seizure (as defined above) who are admitted to a hospital for routine vEEG monitoring related to seizures. Patients who are expected to have a convulsive seizure during their monitoring based on interpretation of clinical history.

Exclusion Criteria

• Patients who are not expected to have their typical convulsive seizure during the course of their hospital admission (i.e. expected reduction due to anti-epileptic drugs during hospital admission).
• Women who are pregnant.
• Patients who are known or suspected to have a history of PNES only.
• Patients with known allergic reactions to nickel or stainless steel
• Infants who were born pre-term and may not have fully developed skin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Subjects	Additional Seizure Monitoring	This is a single arm study With a device intervention of Additional Seizure Monitoring

Primary Outcome Measures

Name	Time	Method
Comparison of Video-EEG to Embrace System	6 months	Lower bound of 95% confidence interval of the positive percent agreement (PPA) greater than 70%, as determined in comparison to Video-EEG adjudicated by 3 independent expert reviewers. A majority rules approach is used to identify convulsive seizures.

Secondary Outcome Measures

Name	Time	Method
False Alarm Rate Tolerability	6 months	70% of the EMU staff that use the Embrace consider the false alarm rate to be neutral or better in tolerability based on a survey.
Patient Care Improvement Measure	6 months	Embrace maintains or improves the level of patient care, as defined by a survey given to the EMU staff.
Embrace System Usability	6 months	Usability of the device perceived by the users (Patients and EMU staff).
Alarm System Comparison	6 months	Lower bound of 95% confidence interval of the positive percent agreement (PPA) greater than 70%, as determined in comparison to standard alarm system available in EMU.

Trial Locations

Locations (2)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit; 🇮🇹 Roma, Italy