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Obstructive Sleep ApneaNCT02907398

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

An observational study of Obstructive Sleep Apnea, run by Inspire Medical Systems, Inc. at 64 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Inspire therapy
Type of treatment
Medical device
How many people
5,000 participants
Where
64 sitesin 5 countries
Study dates
19 Oct 2016to Dec 2025
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

64 sites in 5 countries.

64 sites in 5 countries

United States53 sites

  • Augusta University

    Augusta, Georgia, 30912

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • The University of Alabama for the University of Alabama at Birmingham

    Birmingham, Alabama, 35294-0111

  • The Neurology Center of Southern California

    Carlsbad, California, 92011

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • St. Luke's Hospital

    Chesterfield, Missouri, 63017

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cincinnati VA Medical Center

    Cincinnati, Ohio, 45220

  • Sleep Management Institute

    Cincinnati, Ohio

  • University Hospitals Case Western

    Cleveland, Ohio, 44106

  • MetroHealth Systems

    Cleveland, Ohio, 44109

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43212

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Wayne State University

    Dearborn, Michigan, 48124

  • Puget Sound ENT

    Edmonds, Washington, 98026

  • Virginia Heart Center for Sleep and Wellness

    Fairfax, Virginia, 22041

  • University of Florida Health

    Gainesville, Florida, 32611

  • Northshore University Hospital

    Glenview, Illinois, 60026

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Richard L Roudebush VA Medical Center

    Indianapolis, Indiana, 46202

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of Southern California

    Los Angeles, California, 90032

  • Advanced ENT and Allergy

    Louisville, Kentucky, 40207

  • University of Tennessee Health Science Center/ Baptist Hospital

    Memphis, Tennessee, 38163

  • Valley Sleep Center

    Mesa, Arizona, 85206

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Middlesex Hospital

    New Haven, Connecticut, 06511

  • Long Island Jewish/Northwell Health

    New Hyde Park, New York, 11040

  • Weill Cornell Medicine

    New York, New York, 10021

  • Ogden Clinic

    Ogden, Utah, 84403

  • Central Florida Pulmonary

    Orlando, Florida, 32803

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-6061

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University and Hospital

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic

    Phoenix, Arizona

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Reading Hospital

    Reading, Pennsylvania, 19610

  • Stanford University Medical Center

    Redwood City, California, 94133

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55901

  • St. Cloud Ear, Nose and Throat Clinic

    Saint Cloud, Minnesota, 56303

  • Valley ENT

    Scottsdale, Arizona, 85260

  • Tampa General Hospital

    Tampa, Florida, 33606

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Michigan Heart - St Joseph Mercy Health System

    Ypsilanti, Michigan, 48197

Other trials in United States

Germany7 sites

  • Technische Universitat Dresden

    Dresden

  • Asklepios Klinik Harburg

    Hamburg, 21075

  • Universitatsklinikum Hamburg Eppendorf

    Hamburge, Germany, 20246

  • University of Lubeck

    Lübeck, 23562

  • Universitäts-HNO-Klinik Mannheim

    Mannheim, 68167

  • Klinikum rechts der Isar der Technischen Universitat Munchen

    Munich, 81675

  • Klinikum Stuttgart-Katharinenhospital

    Stuttgart, 70174

Other trials in Germany

Netherlands2 sites

  • OLVG

    Amsterdam, 1061 AE

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein

Other trials in Netherlands

Belgium1 site

  • Universitair Ziekenhuis Antwerpen

    Edegem

Other trials in Belgium

Switzerland1 site

  • Kantonnspital Baselland-Liestal

    Liestal

Other trials in Switzerland

About this study

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.

Read the 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.

Being tested
Inspire therapy, No intervention
Keywords
Neurostimulation, Hypoglossal nerve, Tongue, Upper airway stimulation, Surgery
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inspire therapyDevice

    Also called ADHERE

  • No interventionOther

    Also called CONTROL

Study groups in NCT02907398
Study groupRoleWhat they receive
ADHEREThis 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).
Receives: Device: Inspire therapy
CONTROLThis 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.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline through 12 months

  2. 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.

    Measured: Baseline through 12 months

Secondary outcomes (7)

  1. 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.

    Measured: Through 12 months

  2. 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.

    Measured: Through 12 months

  3. Advance or Additional Titrations

    The patient will report the number of in-office or sleep lab device titrations completed.

    Measured: Through 12 months

  4. 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.

    Measured: Baseline through 12 months

  5. 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).

    Measured: Baseline through 12 months

  6. Device Data Collection

    Device programming and adjustment data recorded during follow-up visits will be collected from physician and patient programmers.

    Measured: Through 12 months

  7. 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.

    Measured: Baseline through 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study start19 Oct 2016
  3. Primary completionSep 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
5,000 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02907398
Sponsor's protocol ID
ADHERE UAS Registry
Status last verified
Mar 2023
First submitted
30 Aug 2016
Last updated
19 Jun 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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.

    PubMed 35236551

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea, run by Inspire Medical Systems, Inc. at 64 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Germany, Netherlands, Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Apnea Hypopnea (AHI) from Baseline to 12-Months (time frame: Baseline through 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02907398, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.

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