Inspire UAS for Obstructive Sleep Apnea in Patients with Higher AHI/BMI
This study is looking at the long-term safety and effectiveness of the Inspire® UAS System for people with obstructive sleep apnea (OSA). The Inspire® UAS System is a device that is implanted to help with breathing during sleep. You might be able to join if you are at least 18 years old and have severe OSA (65 to 100 AHI) or moderate to severe OSA (15 to 100 AHI) with a higher body mass index (BMI between 32 and 40). The main goal is to see how safe the device is over five years. This is an observational study, meaning researchers will watch how the device works in a real-world setting. The current recruitment status is unclear.
- Study design
- This is an observational study with a planned enrollment of 70 participants. It is designed to collect long-term safety and effectiveness data.
- What's involved
- Participants will have an Inspire® UAS System implanted and will use a remote to start therapy each night. The study will track safety and tolerability for 5 years after the implant.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 5 years after the Inspire® UAS System is implanted to monitor for adverse events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study
At a glance
Conditions
Where it's being run
5 sites across 5 statesWho to contact
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What this trial measures
- Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability)5 years post-implant
Procedure-related Adverse Events; Device-related Adverse Events