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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Characterizing Generalized Seizure Detection And Alerting In The Epilepsy Monitoring Unit With The Empatica Embrace Watch And Smartphone-Based Alert System

Conditions
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Epilepsy

Intervention / Treatment
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* Device: Additional Seizure Monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All Subjects<br>This is a single arm study With a device intervention of Additional Seizure Monitoring | Device: Additional Seizure Monitoring<br>* Embrace could offer an additional layer of seizure monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Video-EEG to Embrace System | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alarm System Comparison | 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. | 6 months | 
| False Alarm Rate Tolerability | 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. | 6 months | 
| Patient Care Improvement Measure | Embrace maintains or improves the level of patient care, as defined by a survey given to the EMU staff. | 6 months | 
| Embrace System Usability | Usability of the device perceived by the users (Patients and EMU staff). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Epilepsy Monitoring Unit, EMU, Seizure, Seizure Detection