Overview
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.
Description
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.
Eligibility
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).