Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
1 other identifier
observational
5,000
5 countries
64
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Longer than P75 for all trials
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedStudy Start
First participant enrolled
October 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJune 19, 2025
March 1, 2023
8.9 years
August 30, 2016
June 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Apnea Hypopnea (AHI) from Baseline to 12-Months
Apnea Hypopnea Index (AHI) is a measure of OSA severity. The AHI will be determined by the AHI score at the post-titration visit compared with the pre-implant baseline score.
Baseline through 12 months
Change in Epworth Sleepiness Scale (ESS) from Baseline to 12 Months
The Epworth Sleepiness Scale (ESS) is a validated instruction that rates a subject's daytime sleepiness. ESS scores range from 0 to 24, with a lower score indicating less daytime sleepiness. An ESS score of 10 or less is equivalent to the normalized population. The ESS efficacy endpoint will be determined by the ESS score at the 12-month follow-up as compared to baseline.
Baseline through 12 months
Secondary Outcomes (7)
Patient Experience with Therapy (PET)
Through 12 months
Therapy Adherence
Through 12 months
Advance or Additional Titrations
Through 12 months
Physical Assessment
Baseline through 12 months
Clinical Global Impression (CGI-I)
Baseline through 12 months
- +2 more secondary outcomes
Study Arms (2)
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).
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.
Interventions
Eligibility Criteria
Patients scheduled for an Inspire implant or who had an Inspire implant prior to the initiation of the Registry. In addition, those patients who were denied insurance coverage for the implant.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
The University of Alabama for the University of Alabama at Birmingham
Birmingham, Alabama, 35294-0111, United States
Valley Sleep Center
Mesa, Arizona, 85206, United States
Mayo Clinic
Phoenix, Arizona, United States
Valley ENT
Scottsdale, Arizona, 85260, United States
The Neurology Center of Southern California
Carlsbad, California, 92011, United States
University of Southern California
Los Angeles, California, 90032, United States
Stanford University Medical Center
Redwood City, California, 94133, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Middlesex Hospital
New Haven, Connecticut, 06511, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida Health
Gainesville, Florida, 32611, United States
Central Florida Pulmonary
Orlando, Florida, 32803, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Augusta University
Augusta, Georgia, 30912, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Northshore University Hospital
Glenview, Illinois, 60026, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Richard L Roudebush VA Medical Center
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Advanced ENT and Allergy
Louisville, Kentucky, 40207, United States
Wayne State University
Dearborn, Michigan, 48124, United States
Michigan Heart - St Joseph Mercy Health System
Ypsilanti, Michigan, 48197, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55901, United States
St. Cloud Ear, Nose and Throat Clinic
Saint Cloud, Minnesota, 56303, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
St. Luke's Hospital
Chesterfield, Missouri, 63017, United States
Hackensack Meridian Health
Hackensack, New Jersey, 07601, United States
Long Island Jewish/Northwell Health
New Hyde Park, New York, 11040, United States
Weill Cornell Medicine
New York, New York, 10021, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220, United States
Sleep Management Institute
Cincinnati, Ohio, United States
University Hospitals Case Western
Cleveland, Ohio, 44106, United States
MetroHealth Systems
Cleveland, Ohio, 44109, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43212, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6061, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University and Hospital
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Reading Hospital
Reading, Pennsylvania, 19610, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Tennessee Health Science Center/ Baptist Hospital
Memphis, Tennessee, 38163, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Ogden Clinic
Ogden, Utah, 84403, United States
Virginia Heart Center for Sleep and Wellness
Fairfax, Virginia, 22041, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Puget Sound ENT
Edmonds, Washington, 98026, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Universitatsklinikum Hamburg Eppendorf
Hamburge, Germany, 20246, Germany
Technische Universitat Dresden
Dresden, Germany
Asklepios Klinik Harburg
Hamburg, 21075, Germany
University of Lubeck
Lübeck, 23562, Germany
Universitäts-HNO-Klinik Mannheim
Mannheim, 68167, Germany
Klinikum rechts der Isar der Technischen Universitat Munchen
Munich, 81675, Germany
Klinikum Stuttgart-Katharinenhospital
Stuttgart, 70174, Germany
OLVG
Amsterdam, 1061 AE, Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, Netherlands
Kantonnspital Baselland-Liestal
Liestal, Switzerland
Related Publications (1)
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.
PMID: 35236551DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gwen Gimmestad
Inspire Medical Systems, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2016
First Posted
September 20, 2016
Study Start
October 19, 2016
Primary Completion
September 1, 2025
Study Completion
December 1, 2025
Last Updated
June 19, 2025
Record last verified: 2023-03