SleepNCT05114616
Assessment of Consciousness States with NextSense Ear Bud Devices
A study testing NextSense EEG-enabled earbuds and Ellcie Healthy Glasses in people with Sleep, run by Emory University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- NextSense EEG-enabled earbuds and Ellcie Healthy Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2021to 22 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Detection of physiological parameters that define wake and various stages of sleep for clinical and research purposes has for decades relied upon systems that acquire physiological signals by way of multiple surface electrodes conveyed via conductive wires to hardware that amplifies and stores information on a central processing unit (CPU). This restricts or burdens human subjects in such a way that free action or movement is difficult and requires that patients be monitored by trained staff in an accredited sleep laboratory which levies substantial financial cost, can be inconvenient for patients and families, and is labor intensive. Visual scoring of the sleep stages is the gold standard in sleep research and medicine. Sleep scoring is performed visually based on the following signals: (1) electrical activity of the brain assessed via electroencephalogram (EEG), (2) electrical activity resulting from the movement of the eyes and eyelids assessed via electrooculogram (EOG) and (3) muscle tone recorded under the chin (submental) assessed via electromyogram (EMG). Scoring is usually performed according to standardized scoring rules: Rechtschaffen and Kales or the AASM. An expert visually classifies consecutive 30-s epochs of polysomnographic (PSG) data (EEG, EOG and EMG) into wake, rapid eye movement (REM) sleep, and non-REM (NREM) sleep (stages N1-N3). The plot of a sequence of sleep stages is called a hypnogram.
Visual scoring by an expert is time consuming and subjective. Several studies have addressed the interrater reliability and found that correspondence between scorers is less than ideal. The main goal of this project is determine the feasibility of two different wearable technologic devices in differentiating conventional sleep metrics (including wake versus the four different sleep stages) versus those derived from simultaneous gold-standard, in-laboratory PSG methods.
Volunteer participants will undergo an overnight stay in a diagnostic sleep laboratory followed by a next-day maintenance of wakefulness testing (MWT) according to standard AASM protocols. While being monitored by way of multiple, standard surface electrodes on their scalp (EEG monitoring), outer canthus of each eye (EOG monitoring), mentalis (chin) and bilateral anterior tibialis (leg) (EMG monitoring), and torso (electro-cardiogram (EKG) monitoring) during conventional PSG, the NextSense ear-EEG device will be positioned within each external ear canal. In order to increase the homeostatic drive to sleep during MWT the following day (providing greater opportunity to assess biometrics of "sleepiness") the researchers will extend wake four hours past each participant's habitual sleep start time, thereby allowing only 3-4 hours of sleep prior to awakening.
The subsequent day MWT consists of four sessions scheduled at 2-hour intervals during which participants will be asked to remain awake/vigilant, while seated in their room with lights off for 40 minutes. Prior to and following each trial, participants will complete standardized subjective metrics of their sleepiness, and surrogate objective measures of alertness including attention tasks, and the N-back task which is a continuous performance task commonly used to assess working memory and working memory capacity. During the three time intervals separating the four MWT trials, participants will be asked to read and repeat two standard sentences included in the Montreal Cognitive Assessment (MoCA) aloud and the voice audio will be recorded for subsequent analysis. Participants will be asked to wear Ellcie Healthy glasses, concurrent with the NextSense ear-EEG device, during each MWT trial, flanker attention tasks, and text read-aloud tasks.
- Conditions
- Sleep
- Being tested
- NextSense EEG-enabled earbuds, Ellcie Healthy Glasses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NextSense EEG-enabled earbudsDevice
Also called EEGBud
Each NextSense EEGBud device comes with a universal-fit and/or custom-fit earmold with biometric sensors to detect the EEG, motion (via tri-axial accelerometers), and heart rate. The custom mold is created employing a 3D printer following capture of the geometry unique to each patients' ears with a ring laser scanner to an accuracy of within 0.1 mm. This design process allows for a custom fit and therefore both comfort and complete, consistent contact with the inner surface of the ear canal, providing high quality capture of signals reflecting brain activity, and head, and eye movements. In addition to the custom fit earmold, universal fit earmolds are available as well. The universal fit earmolds were designed also to allow for comfort and consisten contact with the inner surface of the ear canal to provide high quality signal capture of brain activity, and head and eye movements.
Ellcie Healthy GlassesDevice
Ellcie Healthy glasses frames are embedded with multi-modal sensors for measuring eye movements, head movement, and ECG.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Study and Daytime MWT | Experimental | Health volunteers completing one overnight sleep study followed by daytime MWT. The sleep study will include standard surface electrodes as well as EEGBuds. Participants will be asked to wear Ellcie Healthy glasses, concurrent with the EEGBuds, during each MWT trial. Receives: Device: NextSense EEG-enabled earbuds; Device: Ellcie Healthy Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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).
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 1 (during overnight assessment of the single study visit)
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.
Measured: Day 2 (during daytime assessment of the single study visit)
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.
Measured: Day 2 (during daytime assessment of the single study visit)
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.
Measured: Day 2 (during daytime assessment of the single study visit)
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.
Measured: Day 2 (during daytime assessment of the single study visit)
Blink Rate
The number of blinks per minute will be assessed with the Ellcie Healthy glasses during MWT.
Measured: Day 2 (during daytime assessment of the single study visit)
Blink Duration
Blink duration (in milliseconds) will be assessed with the Ellcie Healthy glasses during MWT.
Measured: Day 2 (during daytime assessment of the single study visit)
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.
Measured: Day 2 (during daytime assessment of the single study visit)
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.
Measured: Day 2 (during daytime assessment of the single study visit)
Amplitude
Amplitude, measured as the proportion of lid aperture, will be assessed with the Ellcie Healthy glasses during MWT.
Measured: Day 2 (during daytime assessment of the single study visit)
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.
Measured: Day 2 (during daytime assessment of the single study visit)
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.
Measured: Day 2 (during daytime assessment of the single study visit)
Total Number of Head Bobs
Total number of head bobs will be assessed with the Ellcie Healthy glasses during MWT.
Measured: Day 2 (during daytime assessment of the single study visit)
Frequency of Head Bobs
Frequency of head bobs will be assessed with the Ellcie Healthy glasses during MWT.
Measured: Day 2 (during daytime assessment of the single study visit)
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.
Measured: Day 2 (during daytime assessment of the single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start18 Nov 2021
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- NextSense, Inc.
- Responsible party
- Principal investigator, David Rye, Emory University
- Investigators
- David Rye, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114616
- Sponsor's protocol ID
- STUDY00003148
- Status last verified
- Jan 2025
- First submitted
- 23 Sep 2021
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Consciousness States with NextSense Ear Bud Devices
- ClinicalTrials.gov ID
- NCT05114616
- Acronym / sponsor ID
- STUDY00003148
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- NextSense, Inc.
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detection of physiological parameters that define wake and various stages of sleep for clinical and research purposes has for decades relied upon systems that acquire physiological signals by way of multiple surface electrodes conveyed via conductive wires to hardware that amplifies and stores information on a central processing unit (CPU). This restricts or burdens human subjects in such a way that free action or movement is difficult and requires that patients be monitored by trained staff in an accredited sleep laboratory which levies substantial financial cost, can be inconvenient for patients and families, and is labor intensive. Visual scoring of the sleep stages is the gold standard in sleep research and medicine. Sleep scoring is performed visually based on the following signals: (1) electrical activity of the brain assessed via electroencephalogram (EEG), (2) electrical activity resulting from the movement of the eyes and eyelids assessed via electrooculogram (EOG) and (3) muscle tone recorded under the chin (submental) assessed via electromyogram (EMG). Scoring is usually performed according to standardized scoring rules: Rechtschaffen and Kales or the AASM. An expert visually classifies consecutive 30-s epochs of polysomnographic (PSG) data (EEG, EOG and EMG) into wake, rapid eye movement (REM) sleep, and non-REM (NREM) sleep (stages N1-N3). The plot of a sequence of sleep stages is called a hypnogram.
Visual scoring by an expert is time consuming and subjective. Several studies have addressed the interrater reliability and found that correspondence between scorers is less than ideal. The main goal of this project is determine the feasibility of two different wearable technologic devices in differentiating conventional sleep metrics (including wake versus the four different sleep stages) versus those derived from simultaneous gold-standard, in-laboratory PSG methods.
Volunteer participants will undergo an overnight stay in a diagnostic sleep laboratory followed by a next-day maintenance of wakefulness testing (MWT) according to standard AASM protocols. While being monitored by way of multiple, standard surface electrodes on their scalp (EEG monitoring), outer canthus of each eye (EOG monitoring), mentalis (chin) and bilateral anterior tibialis (leg) (EMG monitoring), and torso (electro-cardiogram (EKG) monitoring) during conventional PSG, the NextSense ear-EEG device will be positioned within each external ear canal. In order to increase the homeostatic drive to sleep during MWT the following day (providing greater opportunity to assess biometrics of "sleepiness") the researchers will extend wake four hours past each participant's habitual sleep start time, thereby allowing only 3-4 hours of sleep prior to awakening.
The subsequent day MWT consists of four sessions scheduled at 2-hour intervals during which participants will be asked to remain awake/vigilant, while seated in their room with lights off for 40 minutes. Prior to and following each trial, participants will complete standardized subjective metrics of their sleepiness, and surrogate objective measures of alertness including attention tasks, and the N-back task which is a continuous performance task commonly used to assess working memory and working memory capacity. During the three time intervals separating the four MWT trials, participants will be asked to read and repeat two standard sentences included in the Montreal Cognitive Assessment (MoCA) aloud and the voice audio will be recorded for subsequent analysis. Participants will be asked to wear Ellcie Healthy glasses, concurrent with the NextSense ear-EEG device, during each MWT trial, flanker attention tasks, and text read-aloud tasks.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Study and Daytime MWT | Experimental | Device: NextSense EEG-enabled earbuds, Device: Ellcie Healthy GlassesHealth volunteers completing one overnight sleep study followed by daytime MWT. The sleep study will include standard surface electrodes as well as EEGBuds. Participants will be asked to wear Ellcie Healthy glasses, concurrent with the EEGBuds, during each MWT trial. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NextSense EEG-enabled earbudsAlso: EEGBudEach NextSense EEGBud device comes with a universal-fit and/or custom-fit earmold with biometric sensors to detect the EEG, motion (via tri-axial accelerometers), and heart rate. The custom mold is created employing a 3D printer following capture of the geometry unique to each patients' ears with a ring laser scanner to an accuracy of within 0.1 mm. This design process allows for a custom fit and therefore both comfort and complete, consistent contact with the inner surface of the ear canal, providing high quality capture of signals reflecting brain activity, and head, and eye movements. In addition to the custom fit earmold, universal fit earmolds are available as well. The universal fit earmolds were designed also to allow for comfort and consisten contact with the inner surface of the ear canal to provide high quality signal capture of brain activity, and head and eye movements. | Device | Sleep Study and Daytime MWT |
| Ellcie Healthy GlassesEllcie Healthy glasses frames are embedded with multi-modal sensors for measuring eye movements, head movement, and ECG. | Device | Sleep Study and Daytime MWT |
Primary outcome
30-second Epoch Related to Wake Stage of Sleep
Time frame: Day 1 (during overnight assessment of the single study visit)
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.
30-second Epoch Related to N1 Stage of Sleep
Time frame: Day 1 (during overnight assessment of the single study visit)
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.
30-second Epoch Related to N2 Stage of Sleep
Time frame: Day 1 (during overnight assessment of the single study visit)
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.
30-second Epoch Related to N3 Stage of Sleep
Time frame: Day 1 (during overnight assessment of the single study visit)
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.
30-second Epoch Related to Rapid Eye Movement (REM) Stage of Sleep
Time frame: Day 1 (during overnight assessment of the single study visit)
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.
30-second Epoch Related to Movement Time
Time frame: Day 1 (during overnight assessment of the single study visit)
The 30-second epochs related to movement time obtained from conventional PSG and the NextSense ear-EEG device will be assessed.
Sleep Onset Latency to Stage N1 Sleep
Time frame: Day 1 (during overnight assessment of the single study visit)
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.
Sleep Onset Latency to Stage N2 Sleep
Time frame: Day 1 (during overnight assessment of the single study visit)
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.
Rapid Eye Movement (REM) Sleep Latency
Time frame: Day 1 (during overnight assessment of the single study visit)
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.
Total Sleep Time
Time frame: Day 1 (during overnight assessment of the single study visit)
The sleep-related parameters obtained from conventional PSG and the NextSense ear-EEG device will be assessed. Total sleep time is measured in minutes.
Wake After Sleep Onset (WASO)
Time frame: Day 1 (during overnight assessment of the single study visit)
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.
Sleep Efficiency
Time frame: Day 1 (during overnight assessment of the single study visit)
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.
Sleep Maintenance Efficiency
Time frame: Day 1 (during overnight assessment of the single study visit)
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).
Time in Each Sleep Stage
Time frame: Day 1 (during overnight assessment of the single study visit)
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.
Number of Arousals
Time frame: Day 1 (during overnight assessment of the single study visit)
The sleep-related parameters obtained from conventional PSG and the NextSense ear-EEG device will be assessed. Arousals from sleep will be counted.
Sleep Onset Latency to Stage N1 Sleep During MWT
Time frame: Day 2 (during daytime assessment of the single study visit)
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.
Sleep Onset Latency to REM Sleep During MWT
Time frame: Day 2 (during daytime assessment of the single study visit)
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.
EEG Power Spectral Analysis During MWT
Time frame: Day 2 (during daytime assessment of the single study visit)
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.
Fast Fourier Transformation (FFT) During MWT
Time frame: Day 2 (during daytime assessment of the single study visit)
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.
Blink Rate
Time frame: Day 2 (during daytime assessment of the single study visit)
The number of blinks per minute will be assessed with the Ellcie Healthy glasses during MWT.
Blink Duration
Time frame: Day 2 (during daytime assessment of the single study visit)
Blink duration (in milliseconds) will be assessed with the Ellcie Healthy glasses during MWT.
Velocity of Eyelid Opening
Time frame: Day 2 (during daytime assessment of the single study visit)
Velocity of eyelid opening, measured as centimeters per second (cm/s), will be assessed with the Ellcie Healthy glasses during MWT.
Velocity of Eyelid Closing
Time frame: Day 2 (during daytime assessment of the single study visit)
Velocity of eyelid closing, measured as centimeters per second (cm/s), will be assessed with the Ellcie Healthy glasses during MWT.
Amplitude
Time frame: Day 2 (during daytime assessment of the single study visit)
Amplitude, measured as the proportion of lid aperture, will be assessed with the Ellcie Healthy glasses during MWT.
Fixation/Saccade Estimation
Time frame: Day 2 (during daytime assessment of the single study visit)
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.
Number of Shifts in Gaze
Time frame: Day 2 (during daytime assessment of the single study visit)
Gaze mobility will be assessed with the Ellcie Healthy glasses during MWT. The number of changes in eye gaze will be evaluated.
Total Number of Head Bobs
Time frame: Day 2 (during daytime assessment of the single study visit)
Total number of head bobs will be assessed with the Ellcie Healthy glasses during MWT.
Frequency of Head Bobs
Time frame: Day 2 (during daytime assessment of the single study visit)
Frequency of head bobs will be assessed with the Ellcie Healthy glasses during MWT.
Acceleration of Head Bobs
Time frame: Day 2 (during daytime assessment of the single study visit)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Rye, MD, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NextSense EEG-enabled earbuds and Ellcie Healthy Glasses in people with Sleep, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-second Epoch Related to Wake Stage of Sleep (time frame: Day 1 (during overnight assessment of the single study visit)). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.