Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Study Overview
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Brief Summary
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Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.

Detailed Description
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All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit. The Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13) Safety and efficacy will be evaluated at Month 7, and again at Month 13.

Official Title
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Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Conditions
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Obstructive Sleep Apnea, OSA, Apnea, Apnea, Obstructive, Apnea, Obstructive Sleep, Apnea+Hypopnea, Hypopnea, Sleep

Intervention / Treatment
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* Device: Hypoglossal Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Abbreviated: Additional criteria may apply: Inclusion Criteria: Diagnosis of moderate to severe OSA Declines to use or does not tolerate PAP therapy Exclusion Criteria: Respiratory, cardiac, renal disease or other co-morbid conditions BMI > 35 kg/m2 Specific PSG criteria outlined in the protocol

Ages Eligible for Study
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Minimum Age: 22 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: Crossover Assignment
Interventional Model Description: All subjects are implanted and randomized. Stimulation treatment started at M1 for the Active group and M7 +1day for the Control group. Both groups followed through M13.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13 | Device: Hypoglossal Nerve Stimulation<br>* Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)<br>|
| Other: Control<br>HGN therapy NOT activated at Month 1 - compared at Month 7 to Active group, stimulation will start at Month 7 + 1 Day and continue through Month 13 | Device: Hypoglossal Nerve Stimulation<br>* Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of response to therapy when compared to no therapy for 6 months | The primary efficacy endpoint is to demonstrate that the AHI responder rate of subjects with the device stimulation activated (Active Group) is statistically significantly higher than the AHI responder rate of subjects with the device stimulation not activated (Control Group) at M7. | Month 1 through Month 7 | 
| Rate of all serious adverse device/procedure related events from time of implant through month 7 | The primary safety endpoint is a descriptive evaluation of all reported serious adverse device/procedure related events (SADEs) through M7 for both groups. Relationship to procedure, device and study will be adjudicated by a Clinical Events Committee (CEC). | Month 1 through Month 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Oxygen Desaturation Index (Efficacy) |  | Baseline through Month 7 | 
| Change in Functional Outcomes of Sleep Questionnaire (Efficacy |  | Baseline through Month 7 | 
| Change in Epworth Sleepiness Scale (Efficacy) |  | Baseline through Month 7 | 
| Change in EQ-5D (Efficacy) |  | Baseline through Month 7 | 
| Change in PROMIS SDI/SRI (Efficacy) |  | Baseline through Month 7 | 
| Change in SF-36 (Efficacy) |  | Baseline through Month 7 | 
| Change in CGI-S/CGI-I (Efficacy) |  | Baseline through Month 7 | 
| Descriptive analysis of all reported Adverse Events (Safety) |  | Consent through Month 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, Snoring, Obstructive Sleep Apnea, CPAP, PAP