Assessment of the Emfit Mattress Sensor for Detection and Alarm of Night-time Generalized Tonic-clonic Seizures.

Sponsor

Emfit, Corp. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02661919

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Seizures	Device: Emfit mattress sensor	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Assessment of the Emfit Mattress Sensor (L-4060SLC) and Monitor (DVM-GPRS-V2) and Their Acoustic and Cloud Interface Notification Capabilities as a Nocturnal Detection System for Movements Associated With Generalized Tonic-clonic Seizures.

Anticipated Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Emfit mattress sensor	Device: Emfit 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.

Arm

Intervention/Treatment

Experimental: Emfit mattress sensor

Device: Emfit 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.