NCT05374941

StimAire Sleep Study

An Interventional Open Feasibility Sleep Study to Determine Effectiveness of StimAire's Injectable and Wearable Neurostimulator in Participants With Obstructive Sleep Apnea

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: StimAire Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Injectable and wearable neurostimulator for the hypoglossal nerve	Temporary placement of injectable and wearable neurostimulator for the hypoglossal nerve

Timeline

• Start date: 2022-08-17
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2022-05-16
• Last updated: 2024-04-18

Locations

1 site across 1 country: Australia