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

Single Center Proof-of-Concept 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

This Proof-of-Concept study will collect acute and sub-acute flow and/or AHI data following the placement of lead arrays under direct vision. The acute placement and data collection will be collected following the completion of the pre-scheduled neck dissection surgery. The sub-acute data will be collected in a sleep lab during a polysomnography (PSG). Both data collections will be done when stimulating (using an external pulse generator) the hypoglossal nerve or Genioglossus muscle (GG) and a second neural target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of Off-the-Shelf (OTS) electrode arrays.

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.