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

This study is currently recruiting participants.
Verified October 2017 by Inspire Medical Systems, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907398
First Posted: September 20, 2016
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Inspire Medical Systems, Inc.
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea Device: Inspire therapy Other: No intervention

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 12 Months
Official Title: Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

Further study details as provided by Inspire Medical Systems, Inc.:

Primary Outcome Measures:
  • Change in Apnea Hypopnea (AHI) from Baseline to 12-Months [ Time Frame: 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 [ Time Frame: Baseline through 12 months ]
    The Epworth Sleepiness Scale (ESS) is a validated instruction that rates a subject's daytime sleepiness. The ESS efficacy endpoint will be determined by the ESS score at the 12-month follow-up as compared to baseline.


Secondary Outcome Measures:
  • Patient Experience with Therapy (PET) [ Time Frame: 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.

  • Therapy Adherence [ Time Frame: 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 [ Time Frame: Through 12 months ]
    The patient will report the number of in-office or sleep lab device titrations completed.

  • Physical Assessment [ Time Frame: 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) [ Time Frame: Baseline through 12 months ]
    The CGI-I is a seven point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.

  • Device Data Collection [ Time Frame: Through 12 months ]
    Device programming and adjustment data recorded during follow-up visits will be collected from physician and patient programmers.


Estimated Enrollment: 2500
Actual Study Start Date: October 19, 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: CONTROL

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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. Must be a legal adult
  2. Capable of giving informed consent, as required per institution
  3. 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907398


Contacts
Contact: Amy Geis 763-957-5035 amygeis@inspiresleep.com

Locations
United States, Alabama
The University of Alabama for the University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-0111
Principal Investigator: Kirk Withrow, MD         
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90032
Principal Investigator: Eric Kezirian, MD         
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Principal Investigator: Stanley H. Chia, MD         
United States, Florida
University of Florida Health Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Margaret Hamer    352-294-5685    mjn18@ufl.edu   
Principal Investigator: John Harwick, MD         
United States, Kansas
Kansas University Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Bryan Humphrey    913-588-3759    bhumphrey@kumc.edu   
Principal Investigator: Christopher Larsen, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Cheryl Stibbe    612-625-1435    edinx004@umn.edu   
Principal Investigator: Conrad Iber, MD         
United States, New York
Cornell University Not yet recruiting
New York, New York, United States, 10065
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Mary Andrews    216-844-2386    Mary.Andrews@UHhospitals.org   
Contact: Stacy Pot       Stacy.Pot@UHhospitals.org   
Principal Investigator: Kingman Strohl, MD         
Sub-Investigator: Mark Weidenbecher, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-6061
Contact: Nadia Azad       Nadia.Azad@uphs.upenn.edu   
Principal Investigator: Richard Schwab, MD         
Thomas Jefferson University and Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Beth Duddy    215-503-6828    elizabeth.duddy@jefferson.edu   
Principal Investigator: Maurits Boon, MD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Tina Harrison    412-232-7207    harrisonta@upmc.edu   
Principal Investigator: Ryan Soose, MD         
Germany
University of Lubeck Recruiting
Lubeck, Germany, 23562
Principal Investigator: Armin Steffen, PD Dr. med.         
Universitäts-HNO-Klinik Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Oliver Schmidt       Oliver.Schmidt@umm.de   
Principal Investigator: Joachim Maurer, MD         
Klinikum rechts der Isar der Technischen Universitat Munchen Recruiting
Munich, Germany, 81675
Principal Investigator: Clemens Heiser, PD Dr. med.         
Sponsors and Collaborators
Inspire Medical Systems, Inc.
Investigators
Study Director: Quan Ni, PhD Inspire Medical Systems, Inc.
  More Information

Responsible Party: Inspire Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT02907398     History of Changes
Other Study ID Numbers: ADHERE UAS Registry
First Submitted: August 30, 2016
First Posted: September 20, 2016
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Inspire Medical Systems, Inc.:
Neurostimulation
Hypoglossal nerve
Tongue
Upper airway stimulation
Surgery

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases