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Neurostimulation Device

aura6000 System for Obstructive Sleep Apnea (THN3 Trial)

N/A
Waitlist Available
Led By Alan R Schwartz, MD
Research Sponsored by ImThera Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months post-implant
Awards & highlights

THN3 Trial Summary

This trial is testing a new device that stimulates a nerve in the tongue to help people with moderate to severe sleep apnea who can't use or don't tolerate traditional treatments.

Eligible Conditions
  • Obstructive Sleep Apnea

THN3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months post-implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in Apnea Hypopnea Index (AHI)
Improvement in Oxygen Desaturation Index (ODI)
Safety Analysis
Secondary outcome measures
Change in Epworth Sleepiness Scale (ESS)
Change in EuroQol 5 Dimensional (EQ-5D)
Change in Functional Outcomes of Sleep (FOSQ)
+1 more

THN3 Trial Design

2Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
The Treatment Group will be implanted with the aura6000 System and have therapy turned ON at the Month 1 follow-up visit.
Group II: ControlExperimental Treatment1 Intervention
The Control Group will be implanted with the aura6000 System and receive treatment as-usual, (i.e. any non-PAP, non-surgical OSA treatment including oral appliances and positional devices being used prior to enrollment in the study) until 14 days (washout period) prior to the Month 4 visit. At the Month 4 + 1 day follow-up visit, subjects in the Control Group will have therapy turned ON for the duration of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
aura6000 System
2015
N/A
~160

Find a Location

Who is running the clinical trial?

ImThera Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
71 Total Patients Enrolled
LivaNovaIndustry Sponsor
64 Previous Clinical Trials
32,507 Total Patients Enrolled
Alan R Schwartz, MDPrincipal InvestigatorProfessor (ret.), Johns Hopkins University
1 Previous Clinical Trials

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?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
Washington
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I feel claustrophobic using a CPAP machine. My snores are loud enough to hear from next door neighbors yard . I wake up tired often and feel sleepy during daytime.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Can I be part of the study from Seattle? Please f not what is the closest facility?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Targeted Hypoglossal Neurostimulation Study #3
2015. "Targeted Hypoglossal Neurostimulation Study #3". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02263859.
~14 spots leftby Apr 2025
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