Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

Acute Proof-of-Concept Study to Evaluate Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea

This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.

Inclusion Criteria:

Subject must be eligible for a diagnostic or surgical procedure and

• Suffers from OSA (apnea/hypopnea index >10 event/h sleep) based on history and a physical exam.
• Is a surgical candidate.
• Is willing and capable of providing informed consent.
• Is willing to have a representative electrode array temporarily placed in the submandibular and mylohyoid space.
• Is willing to participate in the designated follow-up visits.
• Must be in good general health.
• Is able to understand and has voluntarily signed and dated the IRB or EC approved informed consent form (ICF) prior to initiation of any screening or study-specific procedure.
• Must be minimum of 18 years and maximum 80 years of age.

Exclusion Criteria:

• Has Body Mass Index above 35 kg/m2.
• Has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
• Has significant co-morbidities making them unable or inappropriate to participate in this POC study.