Epilepsy
Conditions
Keywords
Epilepsy, Epilepsy Monitoring Unit, EMU, Seizure, Seizure Detection
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).
Interventions
DEVICEAdditional Seizure Monitoring
Embrace could offer an additional layer of seizure monitoring
Sponsors
Empatica, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Video-EEG to Embrace System | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alarm System Comparison | 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 | 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 | 6 months | Embrace maintains or improves the level of patient care, as defined by a survey given to the EMU staff. |
| Embrace System Usability | 6 months | Usability of the device perceived by the users (Patients and EMU staff). |
Countries
Italy, United States
Outcome results
None listed