Clinical Trial TitleAdherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
National Clinical Trial Number:NCT02907398
Clinical Trial Protocol Description:
The purpose of this registry is to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis.
In addition, a sub-study will be conducted under this registry at a limited number of registry centers and will include a cohort of registry patients and a cohort of patients who have not received the Inspire therapy device due to denial of insurance coverage. The two sub-study cohorts' quality of life and AHI data will be compared.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Capable of giving informed consent, as required per institution.
- Willing to return for routine clinic visits as required for Inspire therapy management.
You will be excluded from the study if any of the following criteria apply to you:
- Has a life expectancy of less than 1 year.
- Any reason the clinician deems patient is unfit for participation in the study.
This is a partial list of inclusion and exclusion criteria.