CompletedNot Applicable

Sleep/Wake State Assessment with Non-invasive Earbuds

United States8 participantsStarted 2021-10-13

Plain-language 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).

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in sleep onset latency

Timeframe: Study visits 1 and 2 (up to 16 days)

Trial details

NCT IDNCT05066009

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-27

View on ClinicalTrials.gov More Hypersomnolence trials