NCT05114616

Brief 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 states such as wake from sleep.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

November 18, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2023

Completed
Last Updated

February 11, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

September 23, 2021

Last Update Submit

February 7, 2025

Conditions

Sleep

Outcome Measures

Primary Outcomes (29)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (1)

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.

Device: NextSense EEG-enabled earbudsDevice: Ellcie Healthy Glasses

Interventions

NextSense EEG-enabled earbudsDEVICE

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.

Also known as: EEGBud
Sleep Study and Daytime MWT
Ellcie Healthy GlassesDEVICE

Ellcie Healthy glasses frames are embedded with multi-modal sensors for measuring eye movements, head movement, and ECG.

Sleep Study and Daytime MWT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Sleep Center

Atlanta, Georgia, 30329, United States

Location

Study Officials

  • David Rye, MD, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2021

First Posted

November 10, 2021

Study Start

November 18, 2021

Primary Completion

September 22, 2023

Study Completion

September 22, 2023

Last Updated

February 11, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)