Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Device: Inspire therapyOther: No intervention
- Registration Number
- NCT02907398
- Lead Sponsor
- Inspire Medical Systems, Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5000
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ADHERE Inspire therapy 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 No intervention 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.
- Primary Outcome Measures
Name Time Method Change in Apnea Hypopnea (AHI) from Baseline to 12-Months Baseline through 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.
Change in Epworth Sleepiness Scale (ESS) from Baseline to 12 Months Baseline through 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.
- Secondary Outcome Measures
Name Time Method Therapy Adherence Through 12 months Therapy use, reported as hours of use per week, is record by Inspire device and can be collected upon interrogation of the device in the clinic. This value can be used to quantify device use and adherence over time.
Advance or Additional Titrations Through 12 months The patient will report the number of in-office or sleep lab device titrations completed.
Patient Experience with Therapy (PET) Through 12 months The PET is a survey deigned to collect information about patients' experience with the Inspire therapy. Information will be collected once the therapy is activated about relative satisfaction with the therapy over time.
Insomnia Severity Index (ISI) Baseline through 12 months The Insomnia Severity Index (ISI) is a 7 item self-report instrument that measures patient perception of both nocturnal and diurnal symptoms of insomnia. Scores range from 0 to 28, with a lower score indicating less severe insomnia.
Physical Assessment Baseline through 12 months Blood pressure, and height (in either cm or in) \& weight (in either kg or lbs) will be used to calculate Body Mass Index at baseline and through study completion.
Clinical Global Impression (CGI-I) Baseline through 12 months The Clinical Global Impression (CGI-I) is a clinician assessment of how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. During the assessment the physician rates the patient's obstructive sleep apnea by selecting 1 of 7 categories that range from very much worse to very much improved (in comparison to baseline).
Device Data Collection Through 12 months Device programming and adjustment data recorded during follow-up visits will be collected from physician and patient programmers.
Trial Locations
- Locations (62)
Central Florida Pulmonary
🇺🇸Orlando, Florida, United States
Valley Sleep Center
🇺🇸Mesa, Arizona, United States
The University of Alabama for the University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, 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, District of Columbia, United States
University of Florida Health
🇺🇸Gainesville, 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
St. Cloud Ear, Nose and Throat Clinic
🇺🇸St. 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
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
Universitatsklinikum Hamburg Eppendorf
🇩🇪Hamburge, Germany
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
Technische Universitat Dresden
🇩🇪Dresden, Germany
Asklepios Klinik Harburg
🇩🇪Hamburg, Germany
University of Lubeck
🇩🇪Lubeck, 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