Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

Clinical Trial Title

Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

National Clinical Trial Number:

NCT02907398

Contact Information

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.

Study Details

Clinical Trial Investigator

Phillip LoSavio, MD

Contant Information

Mahendra Shah

Clinical Trial Location

Rush University Medical Center

Location

Rush University Medical Center

1620 W Harrison St
Chicago, IL 60612

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