Earbud EEG Feasibility Study

NCT ID: NCT05257811

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-08-25

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 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

NextSense, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Winkel, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00090515

Identifier Type: -

Identifier Source: org_study_id