Clinical trial NCT05257811: Earbud EEG Feasibility Study
Official title: Earbud Electrode Electroencephalography System - Initial Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy; Seizure
Sleep
Keywords: electroencephalography
polysomnography
Lead sponsor: NextSense, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Emory University
First posted: 2022-02-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: Ease of use and tolerability validation of EEG earbuds for patients undergoing cEEG monitoring or polysomnography.
timeFrame: up to 2 weeks
measure: Performance validation of EEG earbuds for patients undergoing cEEG monitoring or polysomnography
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Daniel Winkel, MD
role: PRINCIPAL_INVESTIGATOR
References: