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

NCT ID: NCT02907398

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-19
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

This registry is a multi-center, prospective, observational registry, conducted in the United States and Europe. Some data may be collected retrospectively in patients currently implanted (implanted prior to enrollment) through the 12-month follow-up time frame. The CE-marked and FDA-approved Inspire system will be used within its intended use, allowing for of use of any future approved system component models. This protocol does not include any additional stressful or invasive tests, which are not a part of standard of care.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

ADHERE

This group will include 250 patients who have been implanted with the Inspire therapy system, enrolled in the ADHERE Registry, and are willing to complete a follow-up home sleep apnea test (HSAT).

Inspire therapy

Intervention Type: DEVICE

CONTROL

This group will include 100 patients who have been denied insurance coverage of the Inspire therapy system implant by their provider, have had no intervention (Inspire), and are willing to complete a HSAT and provide information about their OSA treatment after denial.

No intervention

Intervention Type: OTHER

Interventions

Inspire therapy

Intervention Type: DEVICE

No intervention

Intervention Type: OTHER

Other Intervention Names

ADHERE; CONTROL

Eligibility Criteria

Inclusion Criteria

Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:

1. Capable of giving informed consent, as required per institution

2. Willing to return for routine clinic visits as required for Inspire therapy management

Exclusion Criteria

Any patient who meets any of the following criteria will not be eligible to participate in the registry

1. Has a life expectancy of less than 1 year

2. Any reason the clinician deems patient is unfit for participation in the study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inspire Medical Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gwen Gimmestad

Role: STUDY_DIRECTOR

Inspire Medical Systems, Inc.

Locations

The University of Alabama for the University of Alabama at Birmingham

Birmingham, Alabama, United States

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

St. Cloud Ear, Nose and Throat Clinic

Saint Cloud, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

St. Luke's Hospital

Chesterfield, Missouri, United States

Hackensack Meridian Health

Hackensack, New Jersey, United States

Long Island Jewish/Northwell Health

New Hyde Park, New York, United States

Weill Cornell Medicine

New York, New York, United States

Cincinnati VA Medical Center

Cincinnati, Ohio, United States

Sleep Management Institute

Cincinnati, Ohio, United States

University Hospitals Case Western

Cleveland, Ohio, United States

MetroHealth Systems

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Thomas Jefferson University and Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Reading Hospital

Reading, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Tennessee Health Science Center/ Baptist Hospital

Memphis, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Ogden Clinic

Ogden, Utah, United States

Virginia Heart Center for Sleep and Wellness

Fairfax, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Puget Sound ENT

Edmonds, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Universitatsklinikum Hamburg Eppendorf

Hamburge, Germany, Germany

Technische Universitat Dresden

Dresden, , Germany

Asklepios Klinik Harburg

Hamburg, , Germany

University of Lubeck

Lübeck, , Germany

Universitäts-HNO-Klinik Mannheim

Mannheim, , Germany

Klinikum rechts der Isar der Technischen Universitat Munchen

Munich, , Germany

Klinikum Stuttgart-Katharinenhospital

Stuttgart, , Germany

OLVG

Amsterdam, , Netherlands

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, , Netherlands

Kantonnspital Baselland-Liestal

Liestal, , Switzerland

Countries

United States; Belgium; Germany; Netherlands; Switzerland

References

Bosschieter PFN, de Vries N, Mehra R, Manchanda S, Padhya TA, Vanderveken OM, Ravesloot MJL; ADHERE Registry Investigators. Similar effect of hypoglossal nerve stimulation for obstructive sleep apnea in 5 disease severity categories. J Clin Sleep Med. 2022 Jun 1;18(6):1657-1665. doi: 10.5664/jcsm.9956.

Reference Type: DERIVED

PMID: 35236551 (View on PubMed)

Other Identifiers

ADHERE UAS Registry

Identifier Type: -

Identifier Source: org_study_id