Earbud EEG Feasibility Study — PRIME  

Sleep Clinical Trial

Official title: Earbud Electrode Electroencephalography System - Initial Feasibility Study

Status Completed

Clinical Trial 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 undergoing simultaneous inpatient continuous EEG monitoring, polysomnography, or ambulatory EEG monitoring at home.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Epilepsy; Seizure
• Seizures
• Sleep

• NCT number: NCT05257811
• Study type: Observational
• Source: NextSense, Inc.
• Status: Completed
• Start date: September 1, 2019
• Completion date: August 25, 2022