Assessment of Remote EEG Monitoring (REMI-EEG) in Pediatric Emergency and Adult Critical Care Units
NCT05818930 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129
Last updated 2024-01-25
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.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
REMI
Diagnostic monitoring
Sponsors & Collaborators
-
Epitel, Inc.
lead INDUSTRY
Principal Investigators
-
Maija Holsti, MD, MPH · University of Utah
-
Amir M Arain, MD, MPH · University of Utah
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-08
- Primary Completion
- 2025-06-30
- Completion
- 2025-10-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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