Sleep/Wake State Assessment with Non-invasive Earbuds

NCT05066009 | Completed FDA Device

• 1 other identifier: STUDY00002651
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Narcolepsy type 1; Narcolepsy type 2; Idiopathic hypersomnia

Outcome Measures

Primary Outcomes (1)

• Change in sleep onset latency

  Sleep onset latency is the time in minutes it takes to transition from wakefulness to sleep. Within-individual change in the mean onset to sleep will be assessed from the two MWT sessions performed as detected by NextSense EEGBuds.

  Study visits 1 and 2 (up to 16 days)

Secondary Outcomes (1)

• Intraclass correlation between measurement methods

  Up to 16 days

Study Arms (2)

Prescribed medication followed by drug holiday

EXPERIMENTAL

Participants will complete the study assessments on a day when they take their prescribed medication(s) to promote wakefulness and then will repeat the study assessments on a day when they do not take the medication.

Device: NextSense EEG-enabled earbuds; Device: Ellcie Healthy eyeglasses; Other: Drug Holiday

Drug holiday followed by prescribed medication

EXPERIMENTAL

Participants will complete the study assessments on a day when they do not take their prescribed medication(s) to promote wakefulness and then will repeat the study assessments on a day when they take their medication as prescribed.

Device: NextSense EEG-enabled earbuds; Device: Ellcie Healthy eyeglasses; Other: Drug Holiday

Interventions

NextSense EEG-enabled earbuds DEVICE

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.

Also known as: EEGBud

Drug holiday followed by prescribed medication; Prescribed medication followed by drug holiday

Ellcie Healthy eyeglasses DEVICE

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

Drug holiday followed by prescribed medication; Prescribed medication followed by drug holiday

Drug Holiday OTHER

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).

Drug holiday followed by prescribed medication; Prescribed medication followed by drug holiday

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults ages 18-60 years of age previously diagnosed with narcolepsy type I (NT1), narcolepsy type 2 (NT2), or idiopathic hypersomnia (IH).
• Requiring daily wake promoting medication(s) continuously for 3 months for diagnosed NT1, NT2 or IH with symptomatic improvement on treatment documented by standard subjective or objective tools.

You may not qualify if:

• Presence of a diagnosed or suspected co-morbid sleep-related breathing disorder, parasomnia, or other sleep-related movement disorder.
• Unstable psychiatric disorder (e.g., acute psychosis, acute suicidal ideation or major depressive episode, active substance abuse/dependence).
• History of malignancy (active or in remission for \< 2 years) or active infectious disease at time of screening.
• Inability to safely tolerate wearing earbuds due to recent injury, skin breakdown, or infection.
• Uncorrected near visual acuity no worse than 20/50.
• Any other condition which may affect the outcome of this study or safety of the participant as determined by the principal investigator.

Sponsors & Collaborators

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

Study Sites (1)

Emory Sleep Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Disorders of Excessive Somnolence; Idiopathic Hypersomnia

Interventions

Treatment Interruption

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Treatment Adherence and Compliance; Attitude to Health; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• David Rye, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: October 13, 2021
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: February 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)