Sleep Clinical Trial
Official title:
Assessment of Consciousness States With NextSense Ear Bud Devices
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.
Status | Recruiting |
Enrollment | 16 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
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 | 30-second Epoch Related to Wake Stage of Sleep | Sleep stage scoring will be derived from 30-second epochs based on American Academy of Sleep Medicine (AASM) scoring criteria for four sleep/wake states, with the outputs from the PSG and the NextSense ear-EEG device being hand scored. The 30-second epochs related to the wake stage of sleep obtained from conventional PSG and the NextSense ear-EEG device will be assessed. | Day 1 (during overnight assessment of the single study visit) | |
Primary | 30-second Epoch Related to N1 Stage of Sleep | Sleep stage scoring will be derived from 30-second epochs based on AASM scoring criteria for four sleep/wake states, with the outputs from the PSG and the NextSense ear-EEG device being hand scored. The 30-second epochs related to the N1 stage of sleep obtained from conventional PSG and the NextSense ear-EEG device will be assessed. | Day 1 (during overnight assessment of the single study visit) | |
Primary | 30-second Epoch Related to N2 Stage of Sleep | Sleep stage scoring will be derived from 30-second epochs based on AASM scoring criteria for four sleep/wake states, with the outputs from the PSG and the NextSense ear-EEG device being hand scored. The 30-second epochs related to the N2 stage of sleep obtained from conventional PSG and the NextSense ear-EEG device will be assessed. | Day 1 (during overnight assessment of the single study visit) | |
Primary | 30-second Epoch Related to N3 Stage of Sleep | Sleep stage scoring will be derived from 30-second epochs based on AASM scoring criteria for four sleep/wake states, with the outputs from the PSG and the NextSense ear-EEG device being hand scored. The 30-second epochs related to the N3 stage of sleep obtained from conventional PSG and the NextSense ear-EEG device will be assessed. | Day 1 (during overnight assessment of the single study visit) | |
Primary | 30-second Epoch Related to Rapid Eye Movement (REM) Stage of Sleep | Sleep stage scoring will be derived from 30-second epochs based on AASM scoring criteria for four sleep/wake states, with the outputs from the PSG and the NextSense ear-EEG device being hand scored. The 30-second epochs related to the REM stage of sleep obtained from conventional PSG and the NextSense ear-EEG device will be assessed. | Day 1 (during overnight assessment of the single study visit) | |
Primary | 30-second Epoch Related to Movement Time | The 30-second epochs related to movement time obtained from conventional PSG and the NextSense ear-EEG device will be assessed. | Day 1 (during overnight assessment of the single study visit) | |
Primary | Sleep Onset Latency to Stage N1 Sleep | The sleep-related parameters obtained from conventional PSG and the NextSense ear-EEG device will be assessed. Sleep onset latency to stage N1 sleep is the time it takes in minutes to transition from wakefulness to sleep. Stage N1 sleep is light sleep which is easy to be awakened from. | Day 1 (during overnight assessment of the single study visit) | |
Primary | Sleep Onset Latency to Stage N2 Sleep | The sleep-related parameters obtained from conventional PSG and the NextSense ear-EEG device will be assessed. Sleep onset latency to stage N2 sleep is the time it takes in minutes to transition deeper sleep. Stage N2 sleep has physical characteristics of heart rate slowing, body temperature dropping, and the beginning of delta waves. | Day 1 (during overnight assessment of the single study visit) | |
Primary | Rapid Eye Movement (REM) Sleep Latency | The sleep-related parameters obtained from conventional PSG and the NextSense ear-EEG device will be assessed. REM sleep latency is the time it takes in minutes to transition from wakefulness to REM sleep. REM sleep is the stage when dreaming occurs. | Day 1 (during overnight assessment of the single study visit) | |
Primary | Total Sleep Time | The sleep-related parameters obtained from conventional PSG and the NextSense ear-EEG device will be assessed. Total sleep time is measured in minutes. | Day 1 (during overnight assessment of the single study visit) | |
Primary | Wake After Sleep Onset (WASO) | The sleep-related parameters obtained from conventional PSG and the NextSense ear-EEG device will be assessed. WASO measures wakefulness (in minutes) after sleep onset. | Day 1 (during overnight assessment of the single study visit) | |
Primary | Sleep Efficiency | The sleep-related parameters obtained from conventional PSG and the NextSense ear-EEG device will be assessed. Sleep efficiency is the percentage of time in bed that is spend sleeping. | Day 1 (during overnight assessment of the single study visit) | |
Primary | Sleep Maintenance Efficiency | The sleep-related parameters obtained from conventional PSG and the NextSense ear-EEG device will be assessed. Sleep maintenance efficiency is total sleep time divided by sleep period time (time is measured in minutes). | Day 1 (during overnight assessment of the single study visit) | |
Primary | Time in Each Sleep Stage | The sleep-related parameters obtained from conventional PSG and the NextSense ear-EEG device will be assessed. Time in sleep stages N1, N2, N3 and REM will be measured in minutes. | Day 1 (during overnight assessment of the single study visit) | |
Primary | Number of Arousals | The sleep-related parameters obtained from conventional PSG and the NextSense ear-EEG device will be assessed. Arousals from sleep will be counted. | Day 1 (during overnight assessment of the single study visit) | |
Primary | Sleep Onset Latency to Stage N1 Sleep During MWT | The sensitivity of the NextSense ear-EEG device and Ellcie Healthy glasses to detect metrics of daytime sleepiness during conventional MWT testing will be assessed. Sleep onset latency to stage N1 sleep is the time it takes in minutes to transition from wakefulness to the first stage of sleep. | Day 2 (during daytime assessment of the single study visit) | |
Primary | Sleep Onset Latency to REM Sleep During MWT | The sensitivity of the NextSense ear-EEG device and Ellcie Healthy glasses to detect metrics of daytime sleepiness during conventional MWT testing will be assessed. REM sleep latency is the time it takes in minutes to transition from wakefulness to REM sleep. | Day 2 (during daytime assessment of the single study visit) | |
Primary | EEG Power Spectral Analysis During MWT | The sensitivity of the NextSense ear-EEG device and Ellcie Healthy glasses to detect metrics of daytime sleepiness during conventional MWT testing will be assessed. The EEG signals from PSG and the NextSense ear-EEG device will be analyzed and compared for spectral power within delta, theta, alpha, and beta frequency bands. | Day 2 (during daytime assessment of the single study visit) | |
Primary | Fast Fourier Transformation (FFT) During MWT | The sensitivity of the NextSense ear-EEG device and Ellcie Healthy glasses to detect metrics of daytime sleepiness during conventional MWT testing will be assessed. EEG spectral analysis using the fast Fourier transformation will be compared between EEG signals from PSG and the NextSense ear-EEG device. | Day 2 (during daytime assessment of the single study visit) | |
Primary | Blink Rate | The number of blinks per minute will be assessed with the Ellcie Healthy glasses during MWT. | Day 2 (during daytime assessment of the single study visit) | |
Primary | Blink Duration | Blink duration (in milliseconds) will be assessed with the Ellcie Healthy glasses during MWT. | Day 2 (during daytime assessment of the single study visit) | |
Primary | Velocity of Eyelid Opening | Velocity of eyelid opening, measured as centimeters per second (cm/s), will be assessed with the Ellcie Healthy glasses during MWT. | Day 2 (during daytime assessment of the single study visit) | |
Primary | Velocity of Eyelid Closing | Velocity of eyelid closing, measured as centimeters per second (cm/s), will be assessed with the Ellcie Healthy glasses during MWT. | Day 2 (during daytime assessment of the single study visit) | |
Primary | Amplitude | Amplitude, measured as the proportion of lid aperture, will be assessed with the Ellcie Healthy glasses during MWT. | Day 2 (during daytime assessment of the single study visit) | |
Primary | Fixation/Saccade Estimation | The fixation (milliseconds when the eye is focused on a target) to saccade (rapid eye movement between fixations) estimation will be assessed with the Ellcie Healthy glasses during MWT. | Day 2 (during daytime assessment of the single study visit) | |
Primary | Number of Shifts in Gaze | Gaze mobility will be assessed with the Ellcie Healthy glasses during MWT. The number of changes in eye gaze will be evaluated. | Day 2 (during daytime assessment of the single study visit) | |
Primary | Total Number of Head Bobs | Total number of head bobs will be assessed with the Ellcie Healthy glasses during MWT. | Day 2 (during daytime assessment of the single study visit) | |
Primary | Frequency of Head Bobs | Frequency of head bobs will be assessed with the Ellcie Healthy glasses during MWT. | Day 2 (during daytime assessment of the single study visit) | |
Primary | Acceleration of Head Bobs | Acceleration of head bobs will be assessed with the Ellcie Healthy glasses during MWT. Head bob acceleration will be measured as angular acceleration in units of angle per unit time squared. | Day 2 (during daytime assessment of the single study visit) |
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