An observational study in Epilepsy; Seizure and Sleep, sponsored by NextSense, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-08.
Sponsored by NextSense, Inc. · Observational
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 undergoing simultaneous inpatient continuous EEG monitoring, polysomnography, or ambulatory EEG monitoring at home.
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 disorders. Standard EEG involves highly time, labor, and cost intensive processes and typically requires subjects to be monitored by specially trained staff in the inpatient setting. Existing ambulatory EEG options are limited to about 3 days in duration because of decline in electrode fidelity beyond that timeframe. There is a need for unobtrusive, easy to use, longitudinal monitoring solutions that can extend to the ambulatory setting.
This study will assess whether novel NextSense EEG Earbuds are able to 1) detect seizures of varying types/localizations as well as interictal epileptiform activity (IEA) waveforms compared to simultaneously recorded conventional scalp EEG, or in some cases, intracranial EEG; and 2) detect characteristic electrographic signatures of AASM defined sleep stages compared to simultaneously recorded polysomnography.
881 studies on the registry are indexed under Seizures; 143 are open to participants now.
This study's enrollment of 21 is below the median of 150 across 235 observational studies indexed under Seizures.
Browse Seizures studies →NextSense, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Up to 100 patients may be invited to participate in the study. These patients will have previously been referred for admission to the epilepsy monitoring unit for either diagnostic or presurgical cEEG, or for polysomnography by the neurologists/epileptologists of the Emory Neurology Department.
Exclusion Criteria:
Each NextSense EEGBud device includes custom-fit earbuds with biometric sensors to detect EEG, motion (via tri-axial accelerometers), and heart rate. A ring laser scanner is used to capture the unique geometry of each participant's ear and external auditory canal. Digital models of the individual ear scans are generated and used to create custom fit, 3D-printed earbuds. This design process allows for consistent contact with the inner surface of the ear canal, providing high quality signal capture of brain activity, cardiac activity, and eye movements.
Ease of use and tolerability validation of EEG earbuds for patients undergoing cEEG monitoring or polysomnography.
Individual tolerance success will be the presence of an interpretable EEG record for at 18 hours a day, for at least three consecutive days. Overall tolerance will be a ≥ 75% ongoing participation rate, i.e. ≤ 25% study "drop-out" rate. Patients will be questioned about the reasons they felt the EEGBuds needed to be removed, in order to improve future tolerance.
Time frame: up to 2 weeks
Performance validation of EEG earbuds for patients undergoing cEEG monitoring or polysomnography
Performance validation is measured as sensitivity (true positive) rate as defined as the total number of true detections divided by the total number of seizures; and specificity (false detection rate \[FDR\]) as defined as 24 x number of false detections divided by the total number of EEG hours, for each test subject. Detections will be classified as "true" or "false" based on majority rule by expert reviewers (classified by ≥ 2/3 of reviewers). Criteria for Success: 1. ≥ 90% of EEG segments deemed "acceptable quality" by expert reviewers 2. Overall seizure detection sensitivity of at least 90% and a mean FDR of no more than 5 per 24 hours 3. Overall spike detection sensitivity of at least 90% and a mean FDR of no more than 3 per hour 4. Overall focal slowing detection sensitivity of at least 75% and a mean FDR of no more than 3 per 24 hours (focal slowing is traditionally more difficult to ascertain so criteria will be slightly less stringent)
Time frame: up to 2 weeks
Plan to share: No
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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NextSense, Inc.