MedTrace Logo

Assessment of Consciousness States with NextSense Ear Bud Devices

NCT05114616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-02-11

No results posted yet for this study

Summary

The goal of this study is to determine the feasibility in continuing to explore NextSense's ear-EEG device (EEGBud) and Ellcie Healthy glasses as wireless, wearable alternatives to the expense, discomfort, and burden in conventional surface electrodes and hardwired signal amplification for assessing consciousness states such as wake from sleep.

Conditions

  • Sleep

Interventions

DEVICE

NextSense EEG-enabled earbuds

Each NextSense EEGBud device comes with a universal-fit and/or custom-fit earmold with biometric sensors to detect the EEG, motion (via tri-axial accelerometers), and heart rate. The custom mold is created employing a 3D printer following capture of the geometry unique to each patients' ears with a ring laser scanner to an accuracy of within 0.1 mm. This design process allows for a custom fit and therefore both comfort and complete, consistent contact with the inner surface of the ear canal, providing high quality capture of signals reflecting brain activity, and head, and eye movements. In addition to the custom fit earmold, universal fit earmolds are available as well. The universal fit earmolds were designed also to allow for comfort and consisten contact with the inner surface of the ear canal to provide high quality signal capture of brain activity, and head and eye movements.

DEVICE

Ellcie Healthy Glasses

Ellcie Healthy glasses frames are embedded with multi-modal sensors for measuring eye movements, head movement, and ECG.

Sponsors & Collaborators

  • NextSense, Inc.

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • David Rye, MD, PhD · Emory University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2023-09-22
Completion
2023-09-22
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 NCT05114616 on ClinicalTrials.gov