A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea

Inclusion Criteria:

A subject 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 judicialprotection.

• Body Mass Index (BMI) < 35 kg/m2.

• OSA (15 < AHI < 80 events/h sleep) documented by a sleep study performed during thepast 24 months in the absence of any major weight change or other medical issues.

• Subject must be eligible for a diagnostic DISE or surgical procedure (acute studymeasures only).

• Written informed consent obtained from the subject prior to performing any studyspecific procedure.

• Willing and capable to comply with all study requirements, including specificlifestyle considerations, evaluation procedures and questionnaires for the wholeduration of the trial.

Exclusion Criteria:

Subjects 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 theelectrode arrays to be positioned.

• Significant comorbidities that contraindicate surgery or general anesthesia/DISE

• Significant tongue weakness

• Any other chronic medical illness or condition that contraindicates a surgicalprocedure or general anesthesia/DISE in the judgment of the investigator.

• Prior surgery or treatments that could compromise the placement and effectiveness ofthe electrode array systems:

• Airway cancer surgery or radiation,

• Mandible or maxilla surgery in the previous 3 years (not counting dentaltreatments),

• Other upper airway surgery to remove obstructions related to OSA in the previous 3months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airwaysurgery),

• Prior hypoglossal nerve stimulation device implantation.

• Currently pregnant, or breastfeeding during the study period