An interventional study of NextSense EEG-enabled earbuds and Ellcie Healthy eyeglasses in Hypersomnolence, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Emory University · Not applicable, Interventional, and Device feasibility
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).
Detection of "sleepiness" has for more than four decades relied upon methods that acquire the electroencephalogram (EEG) from multiple surface electrodes applied to the scalp and hardware that amplifies and stores information on a central processing unit (CPU). There are substantial limitations to this methodology beyond the fact that it is time, labor, and cost intensive. Such procedures restrict a subject's freedom of movement and necessitate that patients are monitored by trained staff in an accredited laboratory which levies substantial time and financial burdens upon patients and families. Finally, the test-re-test reliability and utility of testing paradigms reliant solely on an EEG 'signature' to detect statistically meaningful - let alone clinically meaningful - changes is dubious, and has come under increased scrutiny.
This study will assess whether novel wearable technology (NextSense EEGBuds and/or Ellcie Healthy Glasses) are able to detect differences in onset to sleep in patients diagnosed as having one of the central disorders of hypersomnolence (e.g., narcolepsy type 1 or type 2, or idiopathic hypersomnia) while using their prescribed wake promoting medication(s) versus while they are not medicated, and how it's sensitivity compares to differences as detected by the standard MWT. The two study visits will occur within 16 days of one another.
181 studies on the registry are indexed under Disorders of Excessive Somnolence; 34 are open to participants now.
This study's enrollment of 8 is below the median of 90 across 139 interventional studies indexed under Disorders of Excessive Somnolence.
Browse Disorders of Excessive Somnolence studies →Emory University is the lead sponsor of 1,405 studies on the registry; 233 are open to participants now.
Of its 233 completed or terminated interventional studies of FDA-regulated products, 176 (76%) have results posted.
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Exclusion Criteria:
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
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
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
Ellcie Healthy glasses frames are embedded with multi-modal sensors for measuring eye movements, head movement, and ECG.
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).
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.
Time frame: Study visits 1 and 2 (up to 16 days)
Intraclass correlation between measurement methods
The coefficient of intraclass correlation (ICC) between the individual sleep onset latencies as derived by NextSense EEGBuds vs. those revealed by gold standard EEG and conventional scoring. Higher correlation values (typically 0.75 to 1.00) indicate greater agreement between the measurements.
Time frame: Up to 16 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2021 to primary completion in Oct 2023, 24 months.
Of 31 interventional studies with no phase under Disorders of Excessive Somnolence, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's 24 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Disorders of Excessive Somnolence →