Assessment of Remote EEG Monitoring (REMI-EEG) in Pediatric Emergency and Adult Critical Care Units
1 other identifier
interventional
129
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2023
CompletedStudy Start
First participant enrolled
March 8, 2023
CompletedFirst Posted
Study publicly available on registry
April 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJanuary 25, 2024
January 1, 2024
2.2 years
March 7, 2023
January 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.)
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.
Time Frame: Through the time of sensor placement for both REMI sensors and a full electroencephalograph (approximately up to one hour).
Study Arms (1)
REMI vs Conventional EEG
OTHERREMI EEG is as Diagnostically useful as conventional EEG at monitoring patients with suspected seizure events.
Interventions
Eligibility Criteria
You may qualify if:
- Clinical EEG has been ordered for suspected seizures
- Age 6 years or older
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epitel, Inc.lead
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maija Holsti, MD, MPH
University of Utah
- PRINCIPAL INVESTIGATOR
Amir M Arain, MD, MPH
University of Utah
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2023
First Posted
April 19, 2023
Study Start
March 8, 2023
Primary Completion
June 1, 2025
Study Completion
October 1, 2025
Last Updated
January 25, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Requests for data can be submitted starting12 months following study publication and the data may be accessible for up to 24 months.
- Access Criteria
- Access to trial IPD can be requested by qualified researchers, and will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement.
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.