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Neurostimulation Device
Targeted Hypoglossal Neurostimulation Study #3 (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
No Placebo-Only Group
Summary
This trial is testing a device that stimulates a nerve in the tongue to help people with severe sleep apnea who can't use standard treatments. The device works by sending small electrical signals to keep the airway open during sleep.
Eligible Conditions
- Obstructive Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 months post-implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months post-implant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Improvement in Apnea Hypopnea Index (AHI)
Improvement in Oxygen Desaturation Index (ODI)
Safety Analysis
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
65 Previous Clinical Trials
31,150 Total Patients Enrolled
Alan R Schwartz, MDPrincipal InvestigatorProfessor (ret.), Johns Hopkins University
1 Previous Clinical Trials