A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults

Study Overview
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Brief Summary
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The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio™ system, used according to its instructions for use, in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 3 years post-surgery.

Detailed Description
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This study is a multicenter, prospective single arm PMCF. Following activation of the Genio™ system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.

Official Title
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A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults.

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Genio(TM) system therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI) < 35 kg/m2 AHI between 15 to 65 events/hour documented by a PSG during the screening phase. Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments. Exclusion Criteria: Night shift worker Significant comorbidities that contraindicates surgery Life expectancy < 12 months Participation in another clinical study (excluding registries) during the study period (3 years).

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: Genio(TM) system therapy<br>Following activation of the Genio™ system at 8 weeks post-surgery, patients will be followed at 12 weeks, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. | Device: Genio(TM) system therapy<br>* Hypoglossal nerve stimulation system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all reported Serious Adverse Events (SAEs) and all procedure- or device-related Adverse Events (AEs) | Incidence of all reported Serious Adverse Events (SAEs) and all procedure- or device-related Adverse Events (AEs) reported during the study | 12 months post-surgery | 
| Change in Apnea-Hypopnea Index from baseline | Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab | 12 months post-surgery | 
| Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire | Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire (FOSQ) | 12 months post-surgery |