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Behavioural Intervention

NextSense EEG-enabled earbuds 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2 (during daytime assessment of the single study visit)
Awards & highlights

Study Summary

This trial is testing a new way to track people's consciousness state by using wireless ear-EEG and glasses.

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.Check my eligibility
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.See study design
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 a healthy adult aged 18-60 and live within 20 miles of the Emory Sleep Center in Atlanta.
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I am 18-60 years old and live within 20 miles of the Emory Sleep Center in Atlanta.
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I sleep 7-8.5 hours a night and go to bed and wake up at the same time every day.
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I do not use sleep aids or medications to stay awake.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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.

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Who is running the clinical trial?

Emory UniversityLead Sponsor
1,632 Previous Clinical Trials
2,556,461 Total Patients Enrolled
2 Trials studying Sleep
21 Patients Enrolled for Sleep
NextSense, Inc.Industry Sponsor
2 Previous Clinical Trials
29 Total Patients Enrolled
1 Trials studying Sleep
21 Patients Enrolled for Sleep
David Rye, MD, PhDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
8 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Sep 2024