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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT05374941
Study type Interventional
Source StimAire Australia Pty Ltd
Contact
Status Terminated
Phase N/A
Start date August 17, 2022
Completion date April 12, 2023

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