Epilepsy, Seizures
Conditions
Keywords
Epilepsy, Seizure, Seizures, Mattress monitor, Bed monitor, Bed alarm, Generalized tonic-clonic seizure, GTC
Brief summary
Sudden unexpected death in epilepsy (SUDEP) is the most important epilepsy-related mode of death. The exact mechanism of SUDEP is not known. It is thought that cardiac and respiratory factors are involved. Several ways of preventing SUDEP have been identified. These include seizure control, stress reduction, physical activity, family's ability to perform CPR, and night supervision. A mattress alarm system that monitors nocturnal seizures can alert family members of night time seizure activity. Thus, a family member could provide aid and therefore potentially avoid SUDEP. The Emfit monitor is intended to perform these tasks. Investigators tested the Emfit mattress monitor DVM-GPRS-V2 in combination with the Emfit bed sensor L-4060SL in the epilepsy monitoring unit and were able to demonstrate that the device has a high predictive value for detection of generalized convulsions and that it can notify caregivers in the early stages of convulsive activity. This study will further investigate the upgraded (connected to a cloud server via an integrated cellular GPRS module) Emfit mattress monitor DVM-GPRS-V2 and the upgraded Emfit mattress sensor L-4060SLC in combination with an acoustic and new cloud-based notification system.
Interventions
DEVICEEmfit mattress sensor
Patients who are being monitored in the Epilepsy Monitoring Unit will have an Emfit mattress sensor placed under their mattress and the effectiveness of the alarm system will be tested.
Sponsors
Emfit, Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Overnight Epilepsy Monitoring Unit admission
Exclusion criteria
* 12 hours or shorter Epilepsy Monitoring Unit admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alarm effectiveness | 22 months | Investigators are testing the efficacy of the Emfit mattress monitor acoustic notifications for detecting GTC seizures. During video-eeg monitoring clinically detected GTC seizures are listed. These records are compared to Emfit monitor sound notications detected at video recordings. The true-positive, false-positive and false-negative calculations are primary outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seizure type distinction | 10 months | Investigators are testing the Emfit matters sensor acoustic notifications efficacy for detecting other than GTC type seizures (partial seizures, non-epileptic events). Investigators are testing the efficacy of the Emfit mattress monitor acoustic notifications for clinically detected seizures. During video-eeg monitoring clinically detected other than GTC type seizures are listed. These records are compared to Emfit monitor sound notications detected at video recordings. The true-positive, false-positive and false-negative calculations are outcome. False-positive notifications are excluded if patient video recording shows rhytmic movement due patient being awake and performing day-time other activity. |
Countries
United States
Contacts
Primary ContactIrena I. Garić, RN, MPH
Outcome results
None listed