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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02907398
• Other study ID #: ADHERE UAS Registry
• Status: Active, not recruiting
• Start date: October 19, 2016
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Inspire Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Inspire therapy

Other:
• No intervention

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Germany	Technische Universitat Dresden	Dresden
Germany	Asklepios Klinik Harburg	Hamburg
Germany	Universitatsklinikum Hamburg Eppendorf	Hamburge
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
Netherlands	OLVG	Amsterdam
Netherlands	St. Antonius Ziekenhuis Nieuwegein	Nieuwegein
Switzerland	Kantonnspital Baselland-Liestal	Liestal
United States	Augusta University	Augusta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	The University of Alabama for the University of Alabama at Birmingham	Birmingham	Alabama
United States	The Neurology Center of Southern California	Carlsbad	California
United States	Medical University of South Carolina	Charleston	South Carolina
United States	St. Luke's Hospital	Chesterfield	Missouri
United States	Rush University Medical Center	Chicago	Illinois
United States	Cincinnati VA Medical Center	Cincinnati	Ohio
United States	Sleep Management Institute	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	MetroHealth Systems	Cleveland	Ohio
United States	University Hospitals Case Western	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Wayne State University	Dearborn	Michigan
United States	Puget Sound ENT	Edmonds	Washington
United States	Virginia Heart Center for Sleep and Wellness	Fairfax	Virginia
United States	University of Florida Health	Gainesville	Florida
United States	Northshore University Hospital	Glenview	Illinois
United States	Hackensack Meridian Health	Hackensack	New Jersey
United States	Baylor College of Medicine	Houston	Texas
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	University of Mississippi Medical Center	Jackson	Mississippi
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	University of Southern California	Los Angeles	California
United States	Advanced ENT and Allergy	Louisville	Kentucky
United States	University of Tennessee Health Science Center/ Baptist Hospital	Memphis	Tennessee
United States	Valley Sleep Center	Mesa	Arizona
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Middlesex Hospital	New Haven	Connecticut
United States	Long Island Jewish/Northwell Health	New Hyde Park	New York
United States	Weill Cornell Medicine	New York	New York
United States	Ogden Clinic	Ogden	Utah
United States	Central Florida Pulmonary	Orlando	Florida
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University and Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Reading Hospital	Reading	Pennsylvania
United States	Stanford University Medical Center	Redwood City	California
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Cloud Ear, Nose and Throat Clinic	Saint Cloud	Minnesota
United States	Valley ENT	Scottsdale	Arizona
United States	Tampa General Hospital	Tampa	Florida
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Michigan Heart - St Joseph Mercy Health System	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Inspire Medical Systems, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Patient Experience with Therapy (PET)	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.	Through 12 months
Secondary	Therapy Adherence	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.	Through 12 months
Secondary	Advance or Additional Titrations	The patient will report the number of in-office or sleep lab device titrations completed.	Through 12 months
Secondary	Physical Assessment	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.	Baseline through 12 months
Secondary	Clinical Global Impression (CGI-I)	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).	Baseline through 12 months
Secondary	Device Data Collection	Device programming and adjustment data recorded during follow-up visits will be collected from physician and patient programmers.	Through 12 months
Secondary	Insomnia Severity Index (ISI)	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.	Baseline through 12 months