A Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects

Inclusion criteria

A patient must meet all of the following inclusion criteria to be eligible for inclusion in this study:

• Age above 18 years not under guardianship, under curatorship or under judicial protection.
• Body Mass Index (BMI) < 38 kg/m2.
• Subject must be eligible for neck dissection surgery.
• Written informed consent obtained from the patient prior to performing any study specific procedure.
• Willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial.

Exclusion criteria

Patients meeting any of the following criteria will be excluded from participation in this study:

• Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned.
• Significant comorbidities that contraindicate surgery or general anesthesia.
• Significant tongue weakness.
• Aerodigestive tract tumor or reconstructive surgery performed at the same time as neck dissection.
• Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
• Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:

• Airway cancer surgery or radiation, or
• Mandible or maxilla surgery in the previous 3 years (not counting dental treatments).
• Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery).
• Prior hypoglossal nerve stimulation device implantation.
• Currently pregnant or breastfeeding during the study period.
• Concomitant oral or pharyngeal surgery.