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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
3
Simulation of a combination of: HGN, AC, GG or strap muscles
Perth Head and Neck Surgery
Perth, Western Australia, Australia
Impacts on acute airway opening
Demonstration of acute airway opening as visually observed under nasoendoscopy when stimulating the HGN or GG and a second target (neural or direct muscle stimulation).
Time frame: Day 0 to 3
Impacts on airflow during a acute assessment
Acute increase in airflow when stimulating the HGN or GG and a second target (neural or direct muscle stimulation), measured by changes in amplitude (mA) during target stimulation.
Time frame: Day 0 to 3
Impacts on airway opening during a sub-acute assessment
Demonstration of sub-acute flow increase and/or AHI reduction when stimulating two targets simultaneously during natural sleep as measured with polysomnography (PSG), measured by polysomnography.
Time frame: Day 0 to 3
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