Sleep/Wake State Assessment with Non-invasive Earbuds
- Conditions
- Hypersomnolence
- Interventions
- Device: NextSense EEG-enabled earbudsDevice: Ellcie Healthy eyeglassesOther: Drug Holiday
- Registration Number
- NCT05066009
- Lead Sponsor
- Emory University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Prescribed medication followed by drug holiday Ellcie Healthy eyeglasses 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. Prescribed medication followed by drug holiday Drug Holiday 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. Drug holiday followed by prescribed medication NextSense EEG-enabled earbuds 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. Drug holiday followed by prescribed medication 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. Prescribed medication followed by drug holiday NextSense EEG-enabled earbuds 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. Drug holiday followed by prescribed medication Ellcie Healthy eyeglasses 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.
- Primary Outcome Measures
Name Time Method Change in sleep onset latency Study visits 1 and 2 (up to 16 days) 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.
- Secondary Outcome Measures
Name Time Method Intraclass correlation between measurement methods Up to 16 days 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.
Trial Locations
- Locations (1)
Emory Sleep Center
🇺🇸Atlanta, Georgia, United States