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Wearable Technology

Ellcie Healthy eyeglasses for Excessive Daytime Sleepiness

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
Adults ages 18-60 years previously diagnosed with narcolepsy type I (NT1), narcolepsy type 2 (NT2), or idiopathic hypersomnia (IH)
Adults ages 18-60 years of age previously diagnosed with narcolepsy type I (NT1), narcolepsy type 2 (NT2), or idiopathic hypersomnia (IH).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study visits 1 and 2 (up to 16 days)
Awards & highlights

Study Summary

This trial looks at whether a new wearable technology can accurately detect when someone falls asleep, compared to standard EEG equipment.

Who is the study for?
This trial is for adults aged 18-60 with narcolepsy type I, II, or idiopathic hypersomnia who've been on wake-promoting meds for at least 3 months. It's not suitable for those with recent ear injuries, unstable psychiatric disorders, active cancer or infections, certain visual impairments, or other sleep-related disorders.Check my eligibility
What is being tested?
The study tests NextSense EEG-enabled earbuds' ability to detect sleep onset compared to standard in-lab EEG during a Maintenance of Wakefulness Test. Participants will be tested both on their regular medication and after a drug holiday.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the EEGBuds or Ellcie Healthy eyeglasses. There might also be risks associated with temporarily stopping wake-promoting medications during the 'drug holiday' phase.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 60 years old and have been diagnosed with narcolepsy or idiopathic hypersomnia.
Select...
I am between 18-60 years old and have been diagnosed with narcolepsy or idiopathic hypersomnia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study visits 1 and 2 (up to 16 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and study visits 1 and 2 (up to 16 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in sleep onset latency
Secondary outcome measures
Intraclass correlation between measurement methods

Trial Design

2Treatment groups
Experimental Treatment
Group I: Prescribed medication followed by drug holidayExperimental Treatment3 Interventions
Participants will complete the study assessments on a day when they take their prescribed medication(s) to promote wakefulness and then will repeat the study assessments on a day when they do not take the medication.
Group II: Drug holiday followed by prescribed medicationExperimental Treatment3 Interventions
Participants will complete the study assessments on a day when they do not take their prescribed medication(s) to promote wakefulness and then will repeat the study assessments on a day when they take their medication as prescribed.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,565 Total Patients Enrolled
NextSense, Inc.Industry Sponsor
2 Previous Clinical Trials
37 Total Patients Enrolled
David Rye, MD, PhDPrincipal InvestigatorEmory University
1 Previous Clinical Trials
16 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Nebraska
How old are they?
18 - 65
What site did they apply to?
Emory Sleep Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Sleep/Wake State Assessment With Non-invasive Earbuds
David Rye 2021. "Sleep/Wake State Assessment With Non-invasive Earbuds". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05066009.
~1 spots leftby Sep 2024
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