The StimAire Model S is intended to treat Obstructive Sleep Apnea (OSA) by stimulating the hypoglossal nerve. The system includes a dedicated neurostimulator and a breathing sensor. The system is to be used in participants diagnosed with moderate to severe Obstructive Sleep Apnea. The Sponsor will be evaluating the change in Apnea-Hypopnea Index (AHI) when using the StimAire Model S system.
The StimAire Model S is intended to treat Obstructive Sleep Apnea (OSA) by stimulating the hypoglossal nerve. The system includes a dedicated neurostimulator and a breathing sensor. The system is to be used in participants diagnosed with moderate to severe Obstructive Sleep Apnea. The Sponsor will be evaluating the change in Apnea-Hypopnea Index (AHI) when using the StimAire Model S system. Single-site controlled AHI measurements both baseline and intervention will be obtained in this open labeled feasibility study. A baseline AHI measurement will be established for each participant, followed by an intervention AHI measurement.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
7
Temporary placement of injectable and wearable neurostimulator for the hypoglossal nerve
Sleep & Breathing Specialist Centre
Sydney, New South Wales, Australia
Change in AHI
Number of apnea or hypopnea events per hour represented by AHI score
Time frame: Up to 15 Months
Change in AHI from baseline for stimulation synchronized with inhalation compared to change in AHI for unsynchronized stimulation
Number of apnea or hypopnea events per hour represented by AHI score
Time frame: Up to 15 Months
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