Generalized Seizure Detection And Alerting In The EMU With The Empatica Embrace Watch And Smartphone-Based Alert System
Characterizing Generalized Seizure Detection And Alerting In The Epilepsy Monitoring Unit With The Empatica Embrace Watch And Smartphone-Based Alert System
1 other identifier
interventional
100
2 countries
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2017
CompletedStudy Start
First participant enrolled
June 30, 2017
CompletedFirst Posted
Study publicly available on registry
July 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedFebruary 2, 2021
February 1, 2021
1.5 years
June 29, 2017
February 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Alarm System Comparison
6 months
False Alarm Rate Tolerability
6 months
Patient Care Improvement Measure
6 months
Embrace System Usability
6 months
Study Arms (1)
All Subjects
OTHERThis is a single arm study With a device intervention of Additional Seizure Monitoring
Interventions
Embrace could offer an additional layer of seizure monitoring
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Empatica, Inc.lead
Study Sites (2)
NYU Langone Medical Center
New York, New York, 10016, United States
Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit
Roma, 00165, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rosalind W Picard, Sc.D.
Empatica, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2017
First Posted
July 5, 2017
Study Start
June 30, 2017
Primary Completion
January 15, 2019
Study Completion
January 1, 2022
Last Updated
February 2, 2021
Record last verified: 2021-02