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

N/AUnknownNCT03207685

Empatica, Inc.100 enrolled

Overview

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).

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Epilepsy

Interventions

Additional Seizure MonitoringDEVICE

Embrace could offer an additional layer of seizure monitoring

Eligibility

Sex: ALLMin age: 1 Month

Medical Language ↔ Plain English

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

Locations (2)

NYU Langone Medical Center

New York, New York, United States

Ospedale Pediatrico Bambino Gesù - Department of Neuroscience, Neurology Unit

Roma, Italy

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

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.

Time frame: 6 months

Patient Care Improvement Measure

Embrace maintains or improves the level of patient care, as defined by a survey given to the EMU staff.

Time frame: 6 months

Embrace System Usability

Usability of the device perceived by the users (Patients and EMU staff).

Time frame: 6 months

Data from ClinicalTrials.gov

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