EpilepsyNCT02661919
Assessment of the Emfit Mattress Sensor for Detection and Alarm of Night-time Generalized Tonic-clonic Seizures.
A study testing Emfit mattress sensor in people with Epilepsy and Seizures, run by Emfit, Corp. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- What is being tested?
- Emfit mattress sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overnight Epilepsy Monitoring Unit admission
Who cannot join
- 12 hours or shorter Epilepsy Monitoring Unit admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
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.
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.
Read more
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.
- Being tested
- Emfit mattress sensor
- Keywords
- Epilepsy, Seizure, Seizures, Mattress monitor, Bed monitor, Bed alarm, Generalized tonic-clonic seizure, GTC
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emfit mattress sensorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Emfit mattress sensor | Experimental | Not described Receives: Device: Emfit mattress sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 22 months
Secondary outcomes (1)
Seizure type distinction
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study start1 Oct 2019 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emfit, Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan U. Schuele, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661919
- Sponsor's protocol ID
- STU00042423
- Status last verified
- Aug 2019
- First submitted
- 14 Mar 2014
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 23747502
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02661919
- Acronym / sponsor ID
- STU00042423
- Keywords
- Epilepsy, Seizure, Seizures, Mattress monitor, Bed monitor, Bed alarm, Generalized tonic-clonic seizure, GTC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Emfit, Corp.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emfit mattress sensor | Experimental | Device: Emfit mattress sensor |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Overnight Epilepsy Monitoring Unit admission
Key exclusion criteria (1 listed)
- 12 hours or shorter Epilepsy Monitoring Unit admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emfit mattress sensorPatients 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. | Device | Emfit mattress sensor |
Primary outcome
Alarm effectiveness
Time frame: 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.
1 secondary outcome
Seizure type distinction
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Background: PubMed 23747502Narechania 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan U. Schuele, MD, MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emfit mattress sensor in people with Epilepsy and Seizures, run by Emfit, Corp. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irena I. Garić, RN, MPH ((312) 926-1672, igaric@nmff.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alarm effectiveness (time frame: 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02661919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.