Status:
COMPLETED
Earbud EEG Feasibility Study
Lead Sponsor:
NextSense, Inc.
Collaborating Sponsors:
Emory University
Conditions:
Epilepsy; Seizure
Sleep
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this study is to characterize the ability of the NextSense ear-EEG device to detect pathologic electrographic signatures of epilepsy and physiologic signatures of sleep in subjects undergo...
Detailed Description
For nearly half a century, conventional electroencephalography (EEG) has been the standard of care for monitoring cerebral activity, particularly in the clinical domains of epilepsy and sleep disorder...
Eligibility Criteria
Inclusion
- All patients 18 years of age and older admitted to the Epilepsy Monitoring Unit at Emory University Hospital for long-term inpatient scalp or intracranial cEEG monitoring for diagnostic or pre-surgical evaluation, or patients 18 years and older admitted to the Emory Sleep Center at the Brain Health Center for polysomnography.
- To enhance the likelihood of having a sufficient number of enrolled subjects with an adequate number of seizures, investigators may identify patients more likely to have epileptic rather than non-epileptic seizures based on the medical history.
- All patients who are undergoing ambulatory EEG monitoring at home.
Exclusion
- Inability to safely tolerate earbuds (e.g. antecedent skin breakdown, recent injury to ear).
- Subjects who cannot have all 16 non-midline scalp EEG electrodes placed, since these EEG channels are required to accurately assess the performance of the seizure detection function.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 25 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05257811
Start Date
September 1 2019
End Date
August 25 2022
Last Update
November 8 2023
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30329