Sleep/Wake State Assessment with Non-invasive Earbuds

Completed · Not applicable

Conditions studied: Hypersomnolence

In brief

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).

Key facts

Study ID

NCT05066009

Run by

Emory University

People needed

8

Starts

2021-10-13

Expected to finish

2023-10-27

Last updated by the study team

2025-02-11

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Emory Sleep Center — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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