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

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

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

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

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