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

NCT02661919 | Unknown FDA Device

• 1 other identifier: STU00042423
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Seizures

Keywords

Epilepsy; Seizure; Seizures; Mattress monitor; Bed monitor; Bed alarm; Generalized tonic-clonic seizure; GTC

Outcome Measures

Primary Outcomes (1)

• Alarm effectiveness

  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.

  22 months

Secondary Outcomes (1)

• Seizure type distinction

  10 months

Study Arms (1)

Emfit mattress sensor

EXPERIMENTAL

Device: Emfit mattress sensor

Interventions

Emfit mattress sensor DEVICE

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.

Emfit mattress sensor

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overnight Epilepsy Monitoring Unit admission

You may not qualify if:

• hours or shorter Epilepsy Monitoring Unit admission

Sponsors & Collaborators

• Emfit, Corp.: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Narechania AP, Garic II, Sen-Gupta I, Macken MP, Gerard EE, Schuele SU. Assessment of a quasi-piezoelectric mattress monitor as a detection system for generalized convulsions. Epilepsy Behav. 2013 Aug;28(2):172-6. doi: 10.1016/j.yebeh.2013.04.017. Epub 2013 Jun 7.

  PMID: 23747502 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephan U. Schuele, MD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irena I. Garić, RN, MPH

CONTACT

(312) 926-1672; igaric@nmff.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: January 25, 2016
• Study Start: October 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

US (1)