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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

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

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

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)

July 31, 2025

Primary Completion (Estimated)

January 1, 2032

Study Completion (Estimated)

January 1, 2032

Study Registration Dates

First Submitted

May 7, 2025

First Submitted That Met QC Criteria

August 4, 2025

First Posted (Actual)

August 8, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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