Generalized Seizure Detection And Alerting In The EMU With The Empatica Embrace Watch And Smartphone-Based Alert System
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|ClinicalTrials.gov Identifier: NCT03207685|
Recruitment Status : Active, not recruiting
First Posted : July 5, 2017
Last Update Posted : February 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Device: Additional Seizure Monitoring||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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 :||June 30, 2017|
|Actual Primary Completion Date :||January 15, 2019|
|Estimated Study Completion Date :||January 2022|
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
- Comparison of Video-EEG to Embrace System [ Time Frame: 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.
- Alarm System Comparison [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]Embrace maintains or improves the level of patient care, as defined by a survey given to the EMU staff.
- Embrace System Usability [ Time Frame: 6 months ]Usability of the device perceived by the users (Patients and EMU staff).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207685
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10016|
|Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit|
|Roma, Italy, 00165|
|Principal Investigator:||Rosalind W Picard, Sc.D.||Empatica, Inc.|