Clinical trial NCT03207685: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
Epilepsy Monitoring Unit
EMU
Seizure
Seizure Detection
Lead sponsor: Empatica, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Comparison of Video-EEG to Embrace System
timeFrame: 6 months
Secondary outcomes:
measure: Alarm System Comparison
timeFrame: 6 months
measure: False Alarm Rate Tolerability
timeFrame: 6 months
measure: Patient Care Improvement Measure
timeFrame: 6 months
measure: Embrace System Usability
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit
Study officials:
affiliation: Empatica, Inc.
name: Rosalind W Picard, Sc.D.
role: PRINCIPAL_INVESTIGATOR
References: