Acute Proof-of-Concept Study to Evaluate 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 an OSA diagnostic or surgical procedure.
Subject suffers with moderate to severe OSA based on history and a physical exam.
Subject has failed, refused or has not tolerated CPAP treatment.
Subject is willing and capable of providing informed consent.
Subject is willing to have a representative electrode array temporarily placed in the submandibular, sublingual and mylohyoid space.
--Subject is willing to participate in the designated follow-up visits.
Subject must be in good general health.
Subject 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.
Subject must be minimum of 21 years and maximum 80 years of age.
Subject's Hypoglossal Nerve must be able to be visualized using ultrasound
Exclusion Criteria: