Targeted Hypoglossal Neurostimulation Study #3

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA that have failed or do not tolerate PAP.

Detailed Description
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The objectives of this study are to evaluate the safety and effectiveness of the aura6000 System for the treatment of moderate to severe obstructive sleep apnea (OSA) in individuals who have failed or do not tolerate positive airway pressure (PAP) therapy or have failed or are intolerant of or refuse indicated alternative OSA treatments (such as oral appliances, positional devices and conventional sleep surgeries). PAP failure is defined as an inability to eliminate OSA (AHI > 20 despite PAP usage) and PAP intolerance is defined as: 1) inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or 2) unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it). The results of this study are anticipated to provide reasonable assurance of the safety and effectiveness of the aura6000 System when used as intended and to support the application for FDA Premarket Approval of the system.

Official Title
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ImThera Medical Targeted Hypoglossal Neurostimulation Study #3

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: aura6000 System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Individual has failed or does not tolerate PAP therapy Has failed or refuses alternative OSA treatments (e.g.surgery, oral appliances, and behavioral treatments) AHI ≥ 20 (Moderate to severe OSA) Exclusion Critera: Implanted with another active implantable device Body mass index (BMI) ≥ 35 kg/m²

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The Treatment Group will be implanted with the aura6000 System and have therapy turned ON at the Month 1 follow-up visit. | Device: aura6000 System<br>* The aura6000 System is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles of the tongue. The aura6000 System stimulates the hypoglossal nerve cyclically and continuously during sleep to maintain muscle tone of the tongue and upper airway during sleep. Stimulation is generated by a programmable, multi-current source, implantable neurostimulator (IPG) and delivered to the hypoglossal nerve by a lead with multi-contact cuff electrode (lead).<br>* Other names: ImThera Medical;|
| Other: Control<br>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. | Device: aura6000 System<br>* The aura6000 System is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles of the tongue. The aura6000 System stimulates the hypoglossal nerve cyclically and continuously during sleep to maintain muscle tone of the tongue and upper airway during sleep. Stimulation is generated by a programmable, multi-current source, implantable neurostimulator (IPG) and delivered to the hypoglossal nerve by a lead with multi-contact cuff electrode (lead).<br>* Other names: ImThera Medical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Apnea Hypopnea Index (AHI) | Proportion of subjects who experience improvement in the apnea-hypopnea index (AHI) at the Month 4 visit as defined above in the AHI Responder definition. It is hypothesized that the observed responder rate in the Treatment Group will be significantly greater than the responder rate in the Control Group at 4 months post-implant. | Baseline to 4 months post-implant | 
| Improvement in Oxygen Desaturation Index (ODI) | Proportion of subjects who experience improvement in the oxygen desaturation index 4% (ODI 4%) at the Month 4 visit as defined above in the ODI Responder definition. It is hypothesized that the observed responder rate in the Treatment Group will be significantly greater than the responder rate in the Control Group at 4 months post-implant. | Baseline to 4 months post-implant | 
| Safety Analysis | Estimate the incidence of serious adverse events (SAEs) related to the aura6000 device or procedure, including any unanticipated adverse device effects. | Baseline to 12 months post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Responder Rate |  | Baseline to 12 months post-implant | 
| Change in Epworth Sleepiness Scale (ESS) |  | Baseline to 4 months post-implant | 
| Change in Functional Outcomes of Sleep (FOSQ) |  | Baseline to 4 months post-implant | 
| Change in EuroQol 5 Dimensional (EQ-5D) |  | Baseline to 4 months post-implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea