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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: No intervention; Device: Inspire therapy

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.

• Study Type: Observational
• Enrollment (Actual): 5000

Contacts and Locations

• Study Contact: Name: Anna Bader; Phone Number: (763) 290-1174; Email: annabader@inspiresleep.com
• Study Contact Backup: Name: Justin Peterson; Email: justinpeterson@inspiresleep.com

Study Locations

• Belgium
  • Edegem, Belgium
    • Universitair Ziekenhuis Antwerpen
• Germany
  • Dresden, Germany
    • Technische Universität Dresden
  • Hamburg, Germany, 21075
    • Asklepios Klinik Harburg
  • Hamburge, Germany, 20246
    • Universitätsklinikum Hamburg Eppendorf
  • Lubeck, Germany, 23562
    • University of Lübeck
  • Mannheim, Germany, 68167
    • Universitäts-HNO-Klinik Mannheim
  • Munich, Germany, 81675
    • Klinikum Rechts Der Isar Der Technischen Universität München
  • Stuttgart, Germany, 70174
    • Klinikum Stuttgart-Katharinenhospital
• Netherlands
  • Amsterdam, Netherlands, 1061 AE
    • OLVG
  • Nieuwegein, Netherlands
    • St. Antonius Ziekenhuis Nieuwegein
• Switzerland
  • Liestal, Switzerland
    • Kantonnspital Baselland-Liestal
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0111
      • The University of Alabama for the University of Alabama at Birmingham
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Valley Sleep Center
    • Phoenix, Arizona, United States
      • Mayo Clinic
    • Scottsdale, Arizona, United States, 85260
      • Valley ENT
  • California
    • Carlsbad, California, United States, 92011
      • The Neurology Center of Southern California
    • Los Angeles, California, United States, 90032
      • University of Southern California
    • Redwood City, California, United States, 94133
      • Stanford University Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Middlesex Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida Health
    • Orlando, Florida, United States, 32803
      • Central Florida Pulmonary
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Glenview, Illinois, United States, 60026
      • Northshore University Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
    • Indianapolis, Indiana, United States, 46202
      • Richard L Roudebush VA Medical Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Advanced ENT and Allergy
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Wayne State University
    • Ypsilanti, Michigan, United States, 48197
      • Michigan Heart - St Joseph Mercy Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Rochester, Minnesota, United States, 55901
      • Mayo Clinic
    • Saint Cloud, Minnesota, United States, 56303
      • St. Cloud Ear, Nose and Throat Clinic
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • St. Luke's Hospital
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Meridian Health
  • New York
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish/Northwell Health
    • New York, New York, United States, 10021
      • Weill Cornell Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati VA Medical Center
    • Cincinnati, Ohio, United States
      • Sleep Management Institute
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Western
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Systems
    • Columbus, Ohio, United States, 43212
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-6061
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University and Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Reading, Pennsylvania, United States, 19610
      • Reading Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center/ Baptist Hospital
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Utah
    • Ogden, Utah, United States, 84403
      • Ogden Clinic
  • Virginia
    • Fairfax, Virginia, United States, 22041
      • Virginia Heart Center for Sleep and Wellness
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Washington
    • Edmonds, Washington, United States, 98026
      • Puget Sound ENT
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College Of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Device: Inspire therapy; Other Names: ADHERE
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.	Other: No intervention; Other Names: CONTROL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Advance or Additional Titrations	The patient will report the number of in-office or sleep lab device titrations completed.	Through 12 months
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
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
Device Data Collection	Device programming and adjustment data recorded during follow-up visits will be collected from physician and patient programmers.	Through 12 months
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

Collaborators and Investigators

• Sponsor: Inspire Medical Systems, Inc.
• Investigators: Study Director: Gwen Gimmestad, Inspire Medical Systems, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2016
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimated): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Tongue; Neurostimulation; Upper airway stimulation; Hypoglossal nerve
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: ADHERE UAS Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED