Obstructive Sleep Apnea Clinical Trial
Official title:
An Interventional Open Feasibility Sleep Study to Determine Effectiveness of StimAire's Injectable and Wearable Neurostimulator in Participants With Obstructive Sleep Apnea
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. ;
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