Targeted Hypoglossal Neurostimulation Study #2

Study Overview
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Brief Summary
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The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

Official Title
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Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System

Conditions
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Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory, Syndrome, Obstructive Sleep Apnea

Intervention / Treatment
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* Device: aura6000 THN System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AHI >20 Noncompliant to CPAP Willing to provide informed consent Willing to comply with all follow-up visits and evaluations Exclusion Criteria: BMI limits COPD Central Sleep Apnea Anatomic variations interfering with device placement or stability.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aura6000 THN Therapy<br>The aura6000 THN system will be implanted and activated for nightly therapy during sleep. | Device: aura6000 THN System<br>* The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Apnea-Hypopnea Index (AHI) | Change from baseline in AHI measured through in-lab polysomnography (PSG). | 3, 6, and 12 months post implant | 
| Reduction in Oxygen Desaturation Index (ODI) | Change from baseline in ODI measured through in-lab polysomnography (PSG). | 3, 6, and 12 months post implant | 
| Freedom from Serious Adverse Events (SAE) | Adverse events and Serious Adverse events post-operatively | 1 and 12 months post implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in sleep fragmentation | Mean change in microarousal index as compared to baseline. | 3, 6, and 12 months post-implant | 
| Improvement in SAQLI | Mean change in SAQLI (Sleep Apnea Quality of Life Index) as compared to baseline. | 3, 6, and 12 months post implant | 
| Improvement in ESS | Mean change in ESS (Epworth Sleepiness Scale) as compared to baseline. | 3, 6, and 12 months post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apnea, Respiration Disorders, Signs and Symptoms, Signs and Symptoms, Respiratory, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiratory Tract Diseases, Sleep Disorders, Intrinsic, Nervous System Diseases, Sleep Disorders