Assessment of Consciousness States with NextSense Ear Bud Devices
Completed · Not applicable
Conditions studied: Sleep
In brief
The goal of this study is to determine the feasibility in continuing to explore NextSense's ear-EEG device (EEGBud) and Ellcie Healthy glasses as wireless, wearable alternatives to the expense, discomfort, and burden in conventional surface electrodes and hardwired signal amplification for assessing consciousness states such as wake from sleep.
Key facts
- Study ID
- NCT05114616
- Run by
- Emory University
- People needed
- 16
- Starts
- 2021-11-18
- Expected to finish
- 2023-09-22
- Last updated by the study team
- 2025-02-11
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy adults ages 18-60 years of age living within 20 miles of the Emory Sleep Center in Atlanta, Georgia.
- Normal body mass index (BMI) (>= 18.5 and <= 28.0 kg/m\^2) at screening visit.
- Has regular sleep-wake habits (e.g., 7-8.5 hours nightly sleep, consistent bed/wake times within 1-2 hours, regular bedtime between 9:30pm-11:30pm, does not oversleep by > 2 hours on weekends).
- Does not require regular sleep aids or wake promoting medications (including some over the counter cold/allergy medications).
You may not qualify if…
- Has a history of diagnosed or suspected sleep disorder (e.g., sleep-related breathing disorders, circadian rhythm sleep-wake disorders, central disorders of hypersomnolence, parasomnias, sleep-related movement disorders, disorders of sleep maintenance or initiation) or other medical condition associated with excessive daytime sleepiness.
- Regular caffeine consumption > 200 mg per day (1 cup of coffee = 80-120 mg).
- Has a history of major psychiatric disorder (e.g., major depression, bipolar disorder, schizophrenia) or suicidal ideation.
- Current or recent (within the past 6 months) substance dependence (including nicotine, marijuana, alcohol, or any other substance that is likely to affect sleep).
- Has a history of diagnosed or suspected attention deficit/hyperactivity disorder.
- Has performed as a nighttime shift-worker within the past 6 months.
- Inability to safely tolerate wearing earbuds due to recent injury, skin breakdown, or infection.
Where it is running
- Emory Sleep Center — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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