Sleep/Wake State Assessment with Non-invasive Earbuds

Description

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

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Study Overview

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Study Details

Study overview

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).

Feasibility of Detecting Within Subject Differences in Sleepiness with NextSense Earbud Electroencephalography Devices

Sleep/Wake State Assessment with Non-invasive Earbuds

Condition
Hypersomnolence
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory Sleep Center, Atlanta, Georgia, United States, 30329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

David Rye, MD, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2023-10-27