Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea

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 Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.

Official Title
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Pivotal Study of the Apnex Medical™ Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 to 80 years Body mass index (BMI) ≤ 35 kg/m² Previously diagnosed with Moderate to severe OSA Individual has failed or does not tolerate PAP therapy

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant. | Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )<br>* The HGNS System in an investigational device that includes three implantable components: a neurostimulator, a stimulation lead, and a respiration sensing lead. The HGNS System is designed to activate the muscles in the upper airway to help keep the airway open during sleep. The HGNS System is intended for the treatment of moderate to severe OSA in individuals that have failed or do not tolerate positive airway pressure (PAP) therapy.<br>|
| Other: Control<br>The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant. | Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )<br>* The HGNS System in an investigational device that includes three implantable components: a neurostimulator, a stimulation lead, and a respiration sensing lead. The HGNS System is designed to activate the muscles in the upper airway to help keep the airway open during sleep. The HGNS System is intended for the treatment of moderate to severe OSA in individuals that have failed or do not tolerate positive airway pressure (PAP) therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in OSA Severity | The proportion of subjects that experience clinically meaningful improvement in AH1 (reduction >50% and AHI <20) and ODI 4% (reduction >= 25% or ODI 4% <5)from Baseline to 6 Months will be significantly greater in the Treatment Group compared to the Control Group | from Baseline to 6 Months | 
| Long-term Reduction in OSA Severity | The proportion of subjects in the Treatment Group that experience clinically relevant improvement in AHI (reduction >50% and AHI <20) and ODI 4% (reduction >=25% or ODI 4% <5 at 12 months compared to Baseline. | 12 months | 
| Safety Analysis | Description of all adverse events | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apnea, OSA, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Hypoglossal Nerve Stimulation, Sleep Disorders, Tongue