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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
Sponsor: Invicta Medical Inc.
Summary
This proof-of-concept study is to collect acute and short-term sub-acute (if applicable) changes in respiratory parameters following the percutaneous placement of electrode arrays. Acute placement and data collection will be conducted while performing a Drug Induced Sleep Endoscopy (DISE) where the goal will be to quantify changes in airflow with stimulation. Data will also be collected during a one- or two-night polysomnography (PSG) to investigate airflow and sleep stability responses with and without different levels of stimulation during sleep. Where feasible, OSA severity data will be collected, as measured via the apnea/hypopnea index (AHI) with stimulation versus without stimulation as a secondary objective. Both data collections will be done when stimulating the hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of electrode arrays either in combination or separately.
Official title: Multicenter Proof-of-Concept Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2023-11-01
Completion Date
2024-11
Last Updated
2024-10-04
Healthy Volunteers
No
Interventions
Target stimulation (HGN, AC, GG, Strap muscles)
Stimulation of the HGN or GG along with AC or strap muscles.
Locations (4)
Illawara ENT
Wollongong, New South Wales, Australia
Complete ENT
Brisbane, Queensland, Australia
Adelaide Institute for Sleep Health, Flinders University
Adelaide, South Australia, Australia
Perth Head and Neck Surgery
Perth, Western Australia, Australia