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

Status unconfirmed · Not applicable

Conditions studied: Epilepsy, Seizures

In brief

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.

Key facts

Study ID
NCT02661919
Run by
Emfit, Corp.
People needed
50
Starts
2019-10-01
Expected to finish
2020-06-30
Last updated by the study team
2019-08-16

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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