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

Sponsor

Empatica, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03207685

Collaborator

(none)

100

Enrollment

Locations

Arm

54.1

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Device: Additional Seizure Monitoring	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 30, 2017

Actual Primary Completion Date :

Jan 15, 2019

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: All Subjects This is a single arm study With a device intervention of Additional Seizure Monitoring	Device: Additional Seizure Monitoring Embrace could offer an additional layer of seizure monitoring

Arm

Intervention/Treatment

Other: All Subjects

This is a single arm study With a device intervention of Additional Seizure Monitoring

Device: Additional Seizure Monitoring

Embrace could offer an additional layer of seizure monitoring

Outcome Measures

Primary Outcome Measures

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

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.
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Medical Center	New York	New York	United States	10016
2	Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit	Roma		Italy	00165