Hypersomnolence Clinical Trial
Official title:
Feasibility of Detecting Within Subject Differences in Sleepiness With NextSense Earbud Electroencephalography Devices
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).
Status | Recruiting |
Enrollment | 8 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Emory Sleep Center | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | NextSense, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Study visits 1 and 2 (up to 16 days) | |
Secondary | 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. | Up to 16 days |
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