Sleep/Wake State Assessment with Non-invasive Earbuds

Summary

This study is a within subject's assessment of whether a novel wearable technology, NextSense electroencephalography earbuds (EEGBuds), is able to detect differences in onset to sleep from wake versus in-laboratory, gold-standard electroencephalography (EEG) utilized as part of a standard four trial Maintenance of Wakefulness Test (MWT) at medicated baseline versus free of prescribed medications for promoting wake (random order).

Conditions

• Hypersomnolence

Interventions

OTHER

Drug Holiday

Participants will not take their prescribed wakefulness promoting medication(s) for one day to complete the study assessments. Medications typically used to promote wakefulness include amphetamine salts (Adderall), armodafinil (Nuvigil), clarithromycin (Biaxin), flumazenil, methylphenidate (Ritalin), and modafinil (Provigil).

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. A unique custom mold is created employing a 3D printer to capture the geometry of a patients' ear and external auditory canal 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 signal capture of 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 consistent 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 eyeglasses

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

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-13

Primary Completion

2023-10-27

Completion

2023-10-27

FDA Device

Yes

Countries

• United States

Study Locations