Clinical trial NCT02907398: Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
Official title: Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: Neurostimulation
Hypoglossal nerve
Tongue
Upper airway stimulation
Surgery
Lead sponsor: Inspire Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Change in Apnea Hypopnea (AHI) from Baseline to 12-Months
timeFrame: Baseline through 12 months
measure: Change in Epworth Sleepiness Scale (ESS) from Baseline to 12 Months
timeFrame: Baseline through 12 months
Secondary outcomes:
measure: Patient Experience with Therapy (PET)
timeFrame: Through 12 months
measure: Therapy Adherence
timeFrame: Through 12 months
measure: Advance or Additional Titrations
timeFrame: Through 12 months
measure: Physical Assessment
timeFrame: Baseline through 12 months
measure: Clinical Global Impression (CGI-I)
timeFrame: Baseline through 12 months
measure: Device Data Collection
timeFrame: Through 12 months
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline through 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama for the University of Alabama at Birmingham
state: Alabama
city: Mesa
country: United States
facility: Valley Sleep Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Scottsdale
country: United States
facility: Valley ENT
state: Arizona
city: Carlsbad
country: United States
facility: The Neurology Center of Southern California
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Redwood City
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: New Haven
country: United States
facility: Middlesex Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Glenview
country: United States
facility: Northshore University Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Indianapolis
country: United States
facility: Richard L Roudebush VA Medical Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Dearborn
country: United States
facility: Wayne State University
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart - St Joseph Mercy Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Cloud
country: United States
facility: St. Cloud Ear, Nose and Throat Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Chesterfield
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Hackensack
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: New Hyde Park
country: United States
facility: Long Island Jewish/Northwell Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Sleep Management Institute
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Western
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Systems
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University and Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee Health Science Center/ Baptist Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Ogden
country: United States
facility: Ogden Clinic
state: Utah
city: Fairfax
country: United States
facility: Virginia Heart Center for Sleep and Wellness
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Edmonds
country: United States
facility: Puget Sound ENT
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Dresden
country: Germany
facility: Technische Universitat Dresden
city: Hamburge
country: Germany
facility: Universitatsklinikum Hamburg Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Lubeck
country: Germany
facility: University of Lubeck
city: Mannheim
country: Germany
facility: Universitäts-HNO-Klinik Mannheim
city: Munich
country: Germany
facility: Klinikum rechts der Isar der Technischen Universitat Munchen
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart-Katharinenhospital
city: Amsterdam
country: Netherlands
facility: OLVG
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Liestal
country: Switzerland
facility: Kantonnspital Baselland-Liestal
Study officials:
affiliation: Inspire Medical Systems, Inc.
name: Gwen Gimmestad
role: STUDY_DIRECTOR
References:
citation: 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.