Sleep/Wake State Assessment with Non-invasive Earbuds

NACompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

October 13, 2021

Primary Completion Date

October 27, 2023

Study Completion Date

October 27, 2023

Conditions
Hypersomnolence
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. 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.

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).

Trial Locations (1)

30329

Emory Sleep Center, Atlanta

All Listed Sponsors
collaborator

NextSense, Inc.

INDUSTRY

lead

Emory University

OTHER

NCT05066009 - Sleep/Wake State Assessment with Non-invasive Earbuds | Biotech Hunter | Biotech Hunter