Epilepsy, Tonic-Clonic
Conditions
Keywords
Seizure Detection, Seizure, Digital Health
Brief summary
To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review during patient hospitalization in an epilepsy monitoring unit (EMU).
Detailed description
To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review, during patient hospitalization in an epilepsy monitoring unit (EMU). Eligible subjects will be issued an EpiWatch device upon admittance into the EMU. The events detected by the EpiWatch will be compared to TC seizures as determined by epileptologists' interpretation of video-EEG recorded for the subject to determine the effectiveness of EpiWatch in detecting TC seizures. EMU standard care practices will not be modified for subjects.
Interventions
DEVICEPhysiological signal monitoring and seizure detection
Data collection and as an adjunct to other methods of seizure monitoring
Sponsors
EpiWatch, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admitted to a site EMU for video-EEG monitoring * Age five and older at the time of enrollment * Has a clinical history of tonic-clonic (TC) seizures or potential for TC seizures * Willing and able to comply with study procedures
Exclusion criteria
* Has participated previously in EpiWatch development studies or contributed any data to the prior development or evaluation of the detector being tested or previous detectors * Has any condition that would prevent proper wearing of the watch, its free movement during a seizure, or create discomfort from wearing the watch * Inability or unwillingness to comply with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of video-EEG to EpiWatch Results for PPA | 6 months | Lower bound of 95% confidence interval of the positive percent agreement (PPA) \> 80%, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers. |
| Comparison of video-EEG to EpiWatch results for FAR | 6 months | Upper bound of 95% confidence interval of the false alarm rate (FAR) \<.71, as determined by comparison to subject video-EEG events as adjudicated based on majority rule of three independent expert reviewers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Ambulation Positive Percent Agreement | 6 months | Estimate the PPA in pediatric participants in ambulation in addition to at rest |
| Pediatric Ambulation False Alarm Rate | 6 months | Estimate the False Alarm Rate in pediatric participants in ambulation in addition to rest |
Countries
United States
Outcome results
None listed