Clinical trial NCT05066009: Sleep/Wake State Assessment with Non-invasive Earbuds
Official title: Feasibility of Detecting Within Subject Differences in Sleepiness with NextSense Earbud Electroencephalography Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypersomnolence
Keywords: Narcolepsy type 1
Narcolepsy type 2
Idiopathic hypersomnia
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: NextSense, Inc.
First posted: 2021-10-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in sleep onset latency
timeFrame: Study visits 1 and 2 (up to 16 days)
Secondary outcomes:
measure: Intraclass correlation between measurement methods
timeFrame: Up to 16 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Sleep Center
state: Georgia
Study officials:
affiliation: Emory University
name: David Rye, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: