EpilepsyNCT05818930
Assessment of Remote EEG Monitoring (REMI-EEG) in Pediatric Emergency and Adult Critical Care Units
A study testing REMI in people with Epilepsy, run by Epitel, Inc. at 1 site in United States.
Trial summary
The goal of this observational study is to compare clinical utility between Remote EEG Monitoring (REMI) and conventional EEG in patients (6 and older) that are undergoing EEG recording in a hospital as part of their routine clinical care. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- REMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2023to Oct 2025
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical EEG has been ordered for suspected seizures
- Age 6 years or older
Who cannot join
- Cannot undergo EEG recordings because of severe head or other injury that prevents EEG recording.
- Transferred immediately for an operation
- Hemodynamically unstable (SBP less than 90 mmHg) at time of EEG placement
- Inability to place four REMI EEG sensors.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to compare clinical utility between Remote EEG Monitoring (REMI) and conventional EEG in patients (6 and older) that are undergoing EEG recording in a hospital as part of their routine clinical care. The main question[s] it aims to answer are:
- What is the concurrence of diagnosis made by epileptologist using REMI and full-EEG signals.
- What is the proportion of participants experiencing as seizure at the time of sensor placement, compared between REMI sensor placement and full-EEG placement.
Participants will wear REMI and conventional EEG electrodes at the same time.
Read the detailed description
Epitel has developed Epilog, a wireless wearable EEG sensor capable of transmitting EEG to a recording, display, and review platform called REMI (Remote EEG Monitoring). Epitel's REMI platform consists of the REMI tablet and four Epilog sensors. The REMI tablet requires connection to secure WiFi access, and Emergency Department and Intensive Critical Care's IT to open access to http://remi.epitel.com. The four epilog sensors communicate directly with the REMI tablet via Bluetooth connection. REMI synchronizes four Epilog sensors placed by hospital Emergency Department (ED) or intensive care unit (ICU) staff within minutes of patient arrival, thus allowing patients who are suspected of having encephalopathy to be evaluated quickly and prior to initial treatment. REMI securely transmits EEG data to its cloud server where data are processed in near real time using Persyst® Mobile software. Data can then be remotely reviewed by clinical team members.
The objective of this protocol is to demonstrate clinical utility of the Epilog EEG sensors with the REMI monitoring platform in children age 6 through adults in the pediatric emergency department and neurocritical care unit, respectively. Patients meeting entry criteria will be enrolled by a bedside clinical team member who is trained in Epilog sensor placement and use of the REMI platform. All participants will have four Epilog sensors placed, in addition to the standard of care full-EEG. The bedside clinician will be asked to make a "baseline" diagnosis based only on the clinical symptoms.
- Conditions
- Epilepsy
- Being tested
- REMI
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMIDiagnostic test
Diagnostic monitoring
| Study group | Role | What they receive |
|---|---|---|
| REMI vs Conventional EEG | Other | REMI EEG is as Diagnostically useful as conventional EEG at monitoring patients with suspected seizure events. Receives: Diagnostic Test: REMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of clinician's diagnostic impression between REMI and conventional electroencephalograph data.
Concurrence of diagnosis made by epileptologist using REMI and full electroencephalograph signals. (I.e., a comparative count of seizure activity identified by an epileptologist using REMI EEG and using conventional EEG.)
Measured: Through the length of time that a patient is actively monitored using both REMI and a full electroencephalograph (up to 24 hours).
Secondary outcomes (1)
Comparison of time to identify epileptiform EEG signals between REMI and conventional electroencephalograph data.
Proportion of participants seizing at the time of sensor placement, compared between REMI sensor placement and full electroencephalograph placement. (I.e., a count of seizure activity identified by an epileptologist using REMI EEG before conventional EEG is connected.)
Measured: Time Frame: Through the time of sensor placement for both REMI sensors and a full electroencephalograph (approximately up to one hour).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start8 Mar 2023
- Primary completionJun 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epitel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maija Holsti, MD, MPH, Principal investigator, University of UtahAmir M Arain, MD, MPH, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818930
- Sponsor's protocol ID
- EpitelUtah22
- Status last verified
- Jan 2024
- First submitted
- 7 Mar 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Epitel will make this highly-valuable data set available to the wider academic community. This could be done by posting appropriate data on the Epilepsy Ecosystem website: https://www.epilepsyecosystem.org/ All data collection is performed using the same Epilog Data Dictionary across clinical sites. Each PI and Study Coordinator is trained on the data dictionary reporting. This dictionary follows the Common Data Elements for Epilepsy Mobile Health Systems for which Epitel was a contributing member. The common data elements are meant to standardize to the extent possible all data collection, reporting, and analysis in the epilepsy mobile health space.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Remote EEG Monitoring (REMI-EEG) in Pediatric Emergency and Adult Critical Care Units
- ClinicalTrials.gov ID
- NCT05818930
- Acronym / sponsor ID
- EpitelUtah22
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Epitel, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Apr 2023 (actual)
- 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.
The goal of this observational study is to compare clinical utility between Remote EEG Monitoring (REMI) and conventional EEG in patients (6 and older) that are undergoing EEG recording in a hospital as part of their routine clinical care. The main question[s] it aims to answer are:
- What is the concurrence of diagnosis made by epileptologist using REMI and full-EEG signals.
- What is the proportion of participants experiencing as seizure at the time of sensor placement, compared between REMI sensor placement and full-EEG placement.
Participants will wear REMI and conventional EEG electrodes at the same time.
Detailed description
Epitel has developed Epilog, a wireless wearable EEG sensor capable of transmitting EEG to a recording, display, and review platform called REMI (Remote EEG Monitoring). Epitel's REMI platform consists of the REMI tablet and four Epilog sensors. The REMI tablet requires connection to secure WiFi access, and Emergency Department and Intensive Critical Care's IT to open access to http://remi.epitel.com. The four epilog sensors communicate directly with the REMI tablet via Bluetooth connection. REMI synchronizes four Epilog sensors placed by hospital Emergency Department (ED) or intensive care unit (ICU) staff within minutes of patient arrival, thus allowing patients who are suspected of having encephalopathy to be evaluated quickly and prior to initial treatment. REMI securely transmits EEG data to its cloud server where data are processed in near real time using Persyst® Mobile software. Data can then be remotely reviewed by clinical team members.
The objective of this protocol is to demonstrate clinical utility of the Epilog EEG sensors with the REMI monitoring platform in children age 6 through adults in the pediatric emergency department and neurocritical care unit, respectively. Patients meeting entry criteria will be enrolled by a bedside clinical team member who is trained in Epilog sensor placement and use of the REMI platform. All participants will have four Epilog sensors placed, in addition to the standard of care full-EEG. The bedside clinician will be asked to make a "baseline" diagnosis based only on the clinical symptoms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REMI vs Conventional EEG | Other | Diagnostic Test: REMIREMI EEG is as Diagnostically useful as conventional EEG at monitoring patients with suspected seizure events. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical EEG has been ordered for suspected seizures
- Age 6 years or older
Key exclusion criteria (4 listed)
- Cannot undergo EEG recordings because of severe head or other injury that prevents EEG recording.
- Transferred immediately for an operation
- Hemodynamically unstable (SBP less than 90 mmHg) at time of EEG placement
- Inability to place four REMI EEG sensors.
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 |
|---|---|---|
| REMIDiagnostic monitoring | Diagnostic test | REMI vs Conventional EEG |
Primary outcome
Comparison of clinician's diagnostic impression between REMI and conventional electroencephalograph data.
Time frame: Through the length of time that a patient is actively monitored using both REMI and a full electroencephalograph (up to 24 hours).
Concurrence of diagnosis made by epileptologist using REMI and full electroencephalograph signals. (I.e., a comparative count of seizure activity identified by an epileptologist using REMI EEG and using conventional EEG.)
1 secondary outcome
Comparison of time to identify epileptiform EEG signals between REMI and conventional electroencephalograph data.
Time frame: Time Frame: Through the time of sensor placement for both REMI sensors and a full electroencephalograph (approximately up to one hour).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: Yes. Epitel will make this highly-valuable data set available to the wider academic community. This could be done by posting appropriate data on the Epilepsy Ecosystem website: https://www.epilepsyecosystem.org/ All data collection is performed using the same Epilog Data Dictionary across clinical sites. Each PI and Study Coordinator is trained on the data dictionary reporting. This dictionary follows the Common Data Elements for Epilepsy Mobile Health Systems for which Epitel was a contributing member. The common data elements are meant to standardize to the extent possible all data collection, reporting, and analysis in the epilepsy mobile health space.
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Epilepsy
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.
Maija Holsti, MD, MPH principal investigator
University of Utah
Amir M Arain, MD, MPH principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMI in people with Epilepsy, run by Epitel, Inc. 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 2 inclusion and 4 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 25 Jan 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of clinician's diagnostic impression between REMI and conventional electroencephalograph data. (time frame: Through the length of time that a patient is actively monitored using both REMI and a full electroencephalograph (up to 24 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.