Earbud EEG Feasibility Study

NCT05257811 | Completed FDA Device

• 1 other identifier: IRB00090515
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Seizure; Sleep

Keywords

electroencephalography; polysomnography

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  up to 2 weeks

Interventions

NextSense EEG-enabled earbuds DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NextSense, Inc.: lead
• Emory University: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Daniel Winkel, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 25, 2022
• Study Start: September 1, 2019
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)