Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study (AHIBMI PAS)

March 23, 2026 updated by: Inspire Medical Systems, Inc.

Inspire UAS High AHI/High BMI Post-Approval Study

The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This post-approval study is a condition of FDA approval and will collect long-term safety and effectiveness data on an expanded population that includes patients with very severe obstructive sleep apnea (65<AHI≤100 events/hr), as well as those with a higher BMI (32<BMI≤40 kg/m2). Participants will be implanted with a commercially available Inspire UAS System. In addition, participants will receive a patient remote which is used to initiate therapy each night.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80923
        • Recruiting
        • Colorado ENT & Allergy
        • Contact:
        • Principal Investigator:
          • Dr. Nicholas Beckmann, DO
    • Florida
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • Florida Sleep Specialists
        • Principal Investigator:
          • Jeremy McConnell, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Hutz, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Damien Stevens, MD
    • New York
      • Rochester, New York, United States, 14642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A post-market sample selected from enrolling center's real-world patient population

Description

Inclusion Criteria:

  1. Subject is at least 18 years of age;
  2. Subject has a diagnosis of severe OSA (65 ≤ AHI ≤ 100) based on a recent sleep study (within 12 months) OR Subject has a diagnosis of moderate to severe OSA (15≤AHI≤100) AND a baseline Body Mass Index of 32<BMI≤40 kg/m2;
  3. Subject has documented failure of, or intolerance to, positive airway pressure treatments (such as CPAP or BPAP machines; NOTE: PAP failure is defined as an inability to eliminate OSA (AHI > 15 despite PAP usage). PAP intolerance is defined as the inability to use PAP (> 5 nights per week, 4 hours of usage per night) or unwillingness to use PAP (e.g. patient returns the PAP system after attempting to use it).
  4. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
  5. Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the study;
  6. Subject is willing and able to provide informed consent.

Exclusion Criteria:

  1. Subject has a combination of central + mixed apneas > 25% of the total apnea-hypopnea index (AHI) based on a recent sleep study (within 12 months);
  2. Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
  3. Subject has any condition or procedure that has compromised neurological control of the upper airway;
  4. Subject is unable or does not have the necessary assistance to operate the patient remote;
  5. Subject is pregnant or plans to become pregnant;
  6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
  7. Subject has a terminal illness with life expectancy < 12 months;
  8. Any other reason the investigator deems the subject is unfit for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
High AHI
Following patients with 65<AHI≤100 events/hr after Inspire Implantation for a period of 5 years
Device: Inspire® UAS System
Participants will be implanted with a commercially available Inspire® UAS System. In addition, participants will receive a patient remote which is used to initiate therapy each night.
High BMI
Following patients with 32<BMI≤40 kg/m2 after Inspire Implantation for a period of 5 years
Device: Inspire® UAS System
Participants will be implanted with a commercially available Inspire® UAS System. In addition, participants will receive a patient remote which is used to initiate therapy each night.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability)
Time Frame: 5 years post-implant
Procedure-related Adverse Events; Device-related Adverse Events
5 years post-implant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Apnea Hypopnea Index Over Time
Time Frame: 5 years post-implant
Evaluation of improvement in Apnea Hypopnea Index (AHI) over time: baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits)
5 years post-implant
Body Mass Index
Time Frame: 5 years post-implant
Body Mass Index will be collected at each yearly follow-up visit.
5 years post-implant
Change in Oxygen Desaturation Index (ODI) Over Time
Time Frame: 5 years post-implant
Evaluation of improvement in Oxygen Desaturation Index (ODI) over time: baseline (pre-implant) ODI compared to ODI after implant (collected and reported at annual study visits)
5 years post-implant
Change in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) Over Time
Time Frame: 5 years post-implant
Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time: baseline (pre-implant) T90 compared to T90 after implant (collected and reported at annual study visits)
5 years post-implant
Change in Epworth Sleepiness Scale (ESS) Over Time
Time Frame: 5 years post-implant
Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time: baseline (pre-implant) ESS compared to ESS after implant (collected and reported at annual study visits)
5 years post-implant

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of Therapy Usage and Adherence Over Time
Time Frame: 5 years post-implant
Therapy usage - reported as hours of use per week, is recorded by the Inspire UAS system and will be captured during the device check at the 6M and annual (1-5 year) study visits. This value will be used to quantify device use and adherence over time.
5 years post-implant
Change in Patient Satisfaction Over Time
Time Frame: 5 years post-implant
A patient satisfaction survey, designed to collect information about the patient's experience with the Inspire UAS system, will be collected at the 6M and annual (1-5 year) study visits. This survey will provide information about relative satisfaction with the therapy over time.
5 years post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inspire Medical Systems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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