HIGH AHI/BMI Study

Clinical Trial Title

Inspire UAS High AHI/High BMI Post-Approval Study

National Clinical Trial Number:

NCT07113288

Clinical Trial Protocol Description:

This post-approval study is a condition of FDA approval and will collect long-term safety and effectiveness data on an expanded population that includes patients with very severe obstructive sleep apnea (65

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

Have a diagnosis of severe OSA (65 ≤ AHI ≤ 100) based on a recent sleep study (within 12 months), or have a diagnosis of moderate to severe OSA (15≤AHI≤100) and a baseline Body Mass Index of 32
Have documented failure of, or intolerance to, positive airway pressure treatments (such as CPAP or BPAP machines).
- NOTE: PAP failure is defined as an inability to eliminate OSA (AHI > 15 despite PAP usage). PAP intolerance is defined as the inability to use PAP (> 5 nights per week, 4 hours of usage per night) or unwillingness to use PAP (e.g. patient returns the PAP system after attempting to use it).
Are willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.