What side effects are associated with this type of intervention?

Wireless, wearable technologies for monitoring sleep, such as NextSense's ear-EEG device and Ellcie Healthy glasses, are generally designed to be non-invasive and comfortable, minimizing side effects. However, other similar treatments like neurofeedback and transcranial electrical stimulation (tES) have reported some side effects. Neurofeedback may cause mild discomfort or headaches, while tES can lead to skin irritation at the electrode site and mild tingling sensations. Pharmacologic agents used for sleep disorders, such as modafinil or sodium oxybate, can cause side effects like headaches, nausea, dizziness, and in some cases, more severe reactions like dependency or cardiovascular issues.

What prior FDA approvals exist?

The FDA has approved several treatments for sleep disorders, including pharmacological agents like sodium oxybate for narcolepsy and dronabinol for obstructive sleep apnea. While there is ongoing research into wearable technologies for monitoring sleep and consciousness states, such as the NextSense ear-EEG device (EEGBud) and Ellcie Healthy glasses, there are no specific FDA approvals for these types of devices yet. Current FDA-approved treatments primarily focus on medications and traditional monitoring methods like polysomnography.

What other types of research exist?

Promising alternatives include the Apple Watch, which has been evaluated for AF detection and can monitor sleep patterns, and electrodermal activity (EDA) sensors, which have shown high sensitivity and specificity for sleep detection. These devices offer non-invasive, comfortable, and accurate monitoring options for sleep patients.

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Behavioural Intervention

EEG Earbuds and Glasses for Sleep

N/A

Recruiting

Led By David Rye, MD, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Does not require regular sleep aids or wake promoting medications (including some over the counter cold/allergy medications)

Healthy adults ages 18-60 years of age living within 20 miles of the Emory Sleep Center in Atlanta, Georgia

Must not have

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

Has a history of major psychiatric disorder (e.g., major depression, bipolar disorder, schizophrenia) or suicidal ideation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2 (during daytime assessment of the single study visit)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests special earbuds and smart glasses as new, comfortable alternatives to traditional wired electrodes in sleep studies. Volunteers will use these devices to measure brain activity and eye movements, making sleep studies less cumbersome and more convenient.

Who is the study for?

Healthy adults aged 18-60, with a normal BMI (18.5-28), living near Emory Sleep Center in Atlanta who don't use sleep aids or have major psychiatric disorders, recent substance dependence, or diagnosed sleep disorders. Participants should have regular sleep patterns and not consume more than 200 mg of caffeine daily.

What is being tested?

The study is testing the NextSense earbuds and Ellcie Healthy glasses as potential replacements for traditional methods used to assess consciousness states like wakefulness from sleep. These devices are wireless alternatives that could be less expensive and more comfortable for users.

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include discomfort from wearing the devices, skin irritation at contact points, or possible interference with normal sleeping patterns due to device usage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not use sleep aids or medications to stay awake.

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I am 18-60 years old and live within 20 miles of the Emory Sleep Center in Atlanta.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with or suspected to have a sleep disorder causing excessive daytime sleepiness.

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I have a history of a major psychiatric disorder or have had thoughts of suicide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 2 (during daytime assessment of the single study visit)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 2 (during daytime assessment of the single study visit)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2 (during daytime assessment of the single study visit) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

30-second Epoch Related to Movement Time

30-second Epoch Related to N1 Stage of Sleep

30-second Epoch Related to N2 Stage of Sleep

+26 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sleep Study and Daytime MWTExperimental Treatment2 Interventions

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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Wearable technologies like NextSense's ear-EEG device (EEGBud) and Ellcie Healthy glasses work by continuously monitoring brain activity and other physiological signals to assess sleep states and consciousness. These devices aim to provide a less invasive and more comfortable alternative to traditional sleep studies, which often require cumbersome equipment. Light therapy glasses, which emit bright light in the morning and filter short-wavelength light in the evening, help regulate circadian rhythms and improve sleep quality. Neurofeedback targets abnormal brain activity to enhance sleep patterns. These treatments are crucial for sleep patients as they offer personalized, real-time insights and interventions that can lead to better sleep quality and overall health.

Neurofeedback for insomnia: Current state of research.Effect of Morning Light Glasses and Night Short-Wavelength Filter Glasses on Sleep-Wake Rhythmicity in Medical Inpatients.Validity, potential clinical utility and comparison of a consumer activity tracker and a research-grade activity tracker in insomnia disorder II: Outside the laboratory.