MedTrace Logo

Earbud EEG Feasibility Study

NCT05257811 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2023-11-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • NextSense, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Winkel, MD · Emory University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-08-25
Completion
2022-08-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257811 on ClinicalTrials.gov