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

Status unconfirmed

Conditions studied: Obstructive Sleep Apnea

In brief

Inspire intends to conduct this registry 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.

Key facts

Study ID

NCT02907398

Run by

Inspire Medical Systems, Inc.

People needed

5000

Starts

2016-10-19

Expected to finish

2025-12-01

Last updated by the study team

2025-06-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:
• Capable of giving informed consent, as required per institution
• Willing to return for routine clinic visits as required for Inspire therapy management

You may not qualify if…

• Any patient who meets any of the following criteria will not be eligible to participate in the registry
• Has a life expectancy of less than 1 year
• Any reason the clinician deems patient is unfit for participation in the study

Where it is running

• Valley Sleep Center — Mesa, Arizona, United States
• Mayo Clinic — Phoenix, Arizona, United States
• Valley ENT — Scottsdale, Arizona, United States
• The Neurology Center of Southern California — Carlsbad, California, United States
• University of Southern California — Los Angeles, California, United States
• Stanford University Medical Center — Redwood City, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Middlesex Hospital — New Haven, Connecticut, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Florida Health — Gainesville, Florida, United States
• Central Florida Pulmonary — Orlando, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Augusta University — Augusta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Northshore University Hospital — Glenview, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Richard L Roudebush VA Medical Center — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Advanced ENT and Allergy — Louisville, Kentucky, United States
• Wayne State University — Dearborn, Michigan, United States
• Michigan Heart - St Joseph Mercy Health System — Ypsilanti, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• The University of Alabama for the University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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