Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA.

Eligibility Criteria

• * 1. Age from 22 to 75 years (inclusive). Participant cannot be under guardianship, under curatorship or under judicial protection.
• 2. Body mass index (BMI) ≤ 32 kg/m2. 3. Positive cricomental space (≥ 0 cm). The cricomental space is the distance between the neck and the bisection of a line from the chin to the cricoid membrane when the head is in a neutral position.
• 4. Has either not tolerated, has failed or refused positive airway pressure (PAP) treatments.
• 5. Moderate to severe OSA (15≤AHI4≤65 where combined central and mixed AHI\<25% of the total AHI) based on a screening HST and confirmed in Baseline PSG.
• 6. Complete concentric collapse at the level of the soft palate based on screening DISE.
• 7. Willing and capable of complying with all study requirements, including specific lifestyle considerations, performing all follow-up visits and sleep studies, evaluation procedures and questionnaires for the whole duration of the trial.
• *
• 1. Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment:
• 1. Severe chronic insomnia,
• 2. Insufficient sleep syndrome (\<6 hours sleep per night),
• 3. Narcolepsy,
• 4. Restless legs syndrome,
• 5. REM behavior disorder,
• 6. Others deemed sufficient disorders that would confound functional sleep assessment in the judgment of the investigator.
• 2. Taking medications that may alter consciousness, the pattern of respiration, or sleep architecture as determined by the investigator.
• 3. Major anatomical or functional abnormalities that would impair the ability of the Genio® System to treat OSA:
• 1. Craniofacial abnormalities narrowing the airway or the implantation site,
• 2. Palatine tonsil size 3+ or 4+ by the Brodsky Classification,
• 3. Fixed upper airway obstructions (tumor, polyps, nasal obstruction),
• 4. Congenital malformations in the airway,
• 5. Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateral unintended tongue deviation during protrusion),
• 6. Existing swallowing difficulty as measured by a score of ≥3 on the EAT-10 questionnaire
• 7. Others deemed sufficient to impair the ability of the Genio® System to treat OSA in the judgment of the investigator.
• 4. Significant comorbidities that contraindicate surgery or general anesthesia:
• 1. Revised Cardiac Risk Index Class III or IV,
• 2. Persistent uncontrolled diagnosed hypertension despite medications,
• 3. Coagulopathy or required anticoagulant medications (such as warfarin, clopidogrel (Plavix) or similar; prophylactic aspirin not exclusionary) that cannot be safely stopped in the perioperative period, Subjects meeting any of the following criteria will be excluded from participation in this study:
• 1. Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment:
• 1. Severe chronic insomnia,
• 2. Insufficient sleep syndrome (\<6 hours sleep per night),
• 3. Narcolepsy,
• 4. Restless legs syndrome,
• 5. REM behavior disorder,
• 6. Others deemed sufficient disorders that would confound functional sleep assessment in the judgment of the investigator.
• 2. Taking medications that may alter consciousness, the pattern of respiration, or sleep architecture as determined by the investigator.
• 3. Major anatomical or functional abnormalities that would impair the ability of the Genio® System to treat OSA:
• 1. Craniofacial abnormalities narrowing the airway or the implantation site,
• 2. Palatine tonsil size 3+ or 4+ by the Brodsky Classification,
• 3. Fixed upper airway obstructions (tumor, polyps, nasal obstruction),
• 4. Congenital malformations in the airway,
• 5. Hypoglossal nerve palsy (bilateral limited tongue movement, or unilateral unintended tongue deviation during protrusion),
• 6. Existing swallowing difficulty as measured by a score of ≥3 on the EAT-10 questionnaire
• 7. Others deemed sufficient to impair the ability of the Genio® System to treat OSA in the judgment of the investigator.
• 4. Significant comorbidities that contraindicate surgery or general anesthesia:
• 1. Revised Cardiac Risk Index Class III or IV,
• 2. Persistent uncontrolled diagnosed hypertension despite medications,
• 3. Coagulopathy or required anticoagulant medications (such as warfarin, clopidogrel (Plavix) or similar; prophylactic aspirin not exclusionary) that cannot be safely stopped in the perioperative period,
• 4. Degenerative neurological disorder (i.e., Parkinson's disease, Alzheimer's disease),
• 5. Acute illness or infection,
• 6. Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
• 5. Diagnosed psychiatric disease (e.g., psychotic illness, uncontrolled major depression or acute anxiety attacks) that prevents participant compliance with the requirements of the investigational study testing,
• 6. Substance or alcohol abuse history within the previous 3 years. Alcohol and substance abuse are defined as follows:
• 7. Life expectancy of less than 12 months.
• 8. Prior surgery or treatments that could compromise the effectiveness of the Genio® System:
• 1. Airway cancer surgery or radiation,
• 2. Mandible or maxilla surgery in the previous 5 years (not counting dental treatments),
• 3. Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery),
• 4. Prior hypoglossal nerve stimulation device implantation.
• 9. Has an Active Implantable Medical Device (AIMD) even if the device can be temporarily turned off.
• 10. Participation in another clinical study with an active treatment arm.
• 11. Plan to become pregnant, currently pregnant, or breastfeeding during the study period.