Obstructive Sleep Apnea (OSA)AHIBMI PASNCT07113288
Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study
An observational study of Obstructive Sleep Apnea (OSA), run by Inspire Medical Systems, Inc. at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Inspire® UAS System
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Jul 2025to 1 Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A post-market sample selected from enrolling center's real-world patient population
Who may be able to join
- Subject is at least 18 years of age;
- 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;
- 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).
- Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
- 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;
- Subject is willing and able to provide informed consent.
Who cannot join
- 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);
- 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;
- Subject has any condition or procedure that has compromised neurological control of the upper airway;
- Subject is unable or does not have the necessary assistance to operate the patient remote;
- Subject is pregnant or plans to become pregnant;
- Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
- Subject has a terminal illness with life expectancy < 12 months;
- Any other reason the investigator deems the subject is unfit for participation in the study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Florida Sleep Specialists
Bradenton, Florida, 34209
Barbara Johns, bjohns@sleepmanatee.com
Jeremy McConnell, MD
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Mahendra Shah, mahendrakumar_shah@rush.edu
Michael Hutz, MD
- Recruiting
Colorado ENT & Allergy
Colorado Springs, Colorado, 80923
Monica Davis, mdavis@coloradoent.com
Dr. Nicholas Beckmann, DO
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Bryan Humphrey, bhumphrey@kumc.edu
Damien Stevens, MD
- Recruiting
University of Rochester
Rochester, New York, 14642
Paul Allen, paul_allen@urmc.rochester.edu
Sveta Karelsky, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Inspire® UAS System
- Keywords
- Obstructive Sleep Apnea, OSA, Inspire, AHI
- 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® UAS SystemDevice
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 group | Role | What they receive |
|---|---|---|
| High AHI | Following patients with 65<AHI≤100 events/hr after Inspire Implantation for a period of 5 years Receives: Device: Inspire® UAS System | |
| High BMI | Following patients with 32<BMI≤40 kg/m2 after Inspire Implantation for a period of 5 years Receives: Device: Inspire® UAS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability)
Procedure-related Adverse Events; Device-related Adverse Events
Measured: 5 years post-implant
Secondary outcomes (5)
Change in Apnea Hypopnea Index Over Time
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)
Measured: 5 years post-implant
Body Mass Index
Body Mass Index will be collected at each yearly follow-up visit.
Measured: 5 years post-implant
Change in Oxygen Desaturation Index (ODI) Over Time
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)
Measured: 5 years post-implant
Change in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) Over Time
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)
Measured: 5 years post-implant
Change in Epworth Sleepiness Scale (ESS) Over Time
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)
Measured: 5 years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start31 Jul 2025
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inspire Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113288
- Sponsor's protocol ID
- 2023-005
- Acronym
- AHIBMI PAS
- Status last verified
- Aug 2025
- First submitted
- 7 May 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspire UAS High AHI/High BMI Post-Approval Study
- ClinicalTrials.gov ID
- NCT07113288
- Acronym / sponsor ID
- AHIBMI PAS / 2023-005
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- Obstructive Sleep Apnea, OSA, Inspire, AHI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Inspire Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High AHI | – | Device: Inspire® UAS SystemFollowing patients with 65<AHI≤100 events/hr after Inspire Implantation for a period of 5 years |
| High BMI | – | Device: Inspire® UAS SystemFollowing patients with 32<BMI≤40 kg/m2 after Inspire Implantation for a period of 5 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A post-market sample selected from enrolling center's real-world patient population
Key inclusion criteria (6 listed)
- Subject is at least 18 years of age;
- 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;
- 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).
- Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
- 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;
Key exclusion criteria (8 listed)
- 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);
- 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;
- Subject has any condition or procedure that has compromised neurological control of the upper airway;
- Subject is unable or does not have the necessary assistance to operate the patient remote;
- Subject is pregnant or plans to become pregnant;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspire® UAS SystemParticipants 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. | Device | High AHI, High BMI |
Primary outcome
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 secondary outcomes
Change in Apnea Hypopnea Index Over Time
Time frame: 5 years post-implant
Body Mass Index
Time frame: 5 years post-implant
Change in Oxygen Desaturation Index (ODI) Over Time
Time frame: 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
Change in Epworth Sleepiness Scale (ESS) Over Time
Time frame: 5 years post-implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA), run by Inspire Medical Systems, Inc. at 5 sites in United States.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gwen Gimmestad (763-392-9966, gwengimmestad@inspiresleep.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability) (time frame: 5 years post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.