NCT05257811

Earbud EEG Feasibility Study

Earbud Electrode Electroencephalography System - Initial Feasibility Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: NextSense, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Epilepsy; Seizure
• Sleep

Interventions

Type	Name	Description
DEVICE	NextSense EEG-enabled earbuds	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.

Timeline

• Start date: 2019-09-01
• Primary completion: 2022-08-25
• Completion: 2022-08-25
• First posted: 2022-02-25
• Last updated: 2023-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study