Back to resultsGeneralized Seizure Detection And Alerting In The EMU With The Empatica Embrace Watch And Smartphone-Based Alert System
Primary Purpose
Epilepsy
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Additional Seizure Monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy focused on measuring Epilepsy, Epilepsy Monitoring Unit, EMU, Seizure, Seizure Detection
Eligibility Criteria
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
Sites / Locations
- NYU Langone Medical Center
- Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All Subjects
Arm Description
This is a single arm study With a device intervention of Additional Seizure Monitoring
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Patient Care Improvement Measure
Embrace maintains or improves the level of patient care, as defined by a survey given to the EMU staff.
Embrace System Usability
Usability of the device perceived by the users (Patients and EMU staff).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03207685
Brief Title
Generalized Seizure Detection And Alerting In The EMU With The Empatica Embrace Watch And Smartphone-Based Alert System
Official Title
Characterizing Generalized Seizure Detection And Alerting In The Epilepsy Monitoring Unit With The Empatica Embrace Watch And Smartphone-Based Alert System
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Empatica, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Epilepsy Monitoring Unit, EMU, Seizure, Seizure Detection
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All Subjects
Arm Type
Other
Arm Description
This is a single arm study With a device intervention of Additional Seizure Monitoring
Intervention Type
Device
Intervention Name(s)
Additional Seizure Monitoring
Intervention Description
Embrace could offer an additional layer of seizure monitoring
Primary Outcome Measure Information:
Title
Comparison of Video-EEG to Embrace System
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Alarm System Comparison
Description
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.
Time Frame
6 months
Title
False Alarm Rate Tolerability
Description
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.
Time Frame
6 months
Title
Patient Care Improvement Measure
Description
Embrace maintains or improves the level of patient care, as defined by a survey given to the EMU staff.
Time Frame
6 months
Title
Embrace System Usability
Description
Usability of the device perceived by the users (Patients and EMU staff).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosalind W Picard, Sc.D.
Organizational Affiliation
Empatica, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit
City
Roma
ZIP/Postal Code
00165
Country
Italy
12. IPD Sharing Statement
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Generalized Seizure Detection And Alerting In The EMU With The Empatica Embrace Watch And Smartphone-Based Alert System
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