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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03207685
• Other study ID #: 2016-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 30, 2017
• Est. completion date: January 2022

Study information

• Verified date: February 2021
• Source: Empatica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2022
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Device:
• Additional Seizure Monitoring
Embrace could offer an additional layer of seizure monitoring

Locations

Country	Name	City	State
Italy	Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit	Roma
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Empatica, Inc.

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Embrace System Usability	Usability of the device perceived by the users (Patients and EMU staff).	6 months