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Long-term follow-up of the Inspire device for obstructive sleep apnea

Follows people with obstructive sleep apnea and higher weight using Inspire.

Key facts

Who runs it
Inspire Medical Systems, Inc.
Where
Bradenton, Chicago, Colorado Springs, Kansas City, and Rochester, United StatesSee the 5 sites
Trial code
Registry title
Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study
Status
Recruiting
People taking part
70 people, planned
Started
31 Jul 2025
Expected to end
1 Jan 2032
Type of study
Observational, 2 groups
Treatments tested
  • Inspire® UAS System
Record updated
27 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with obstructive sleep apnea who could not use or did not do well on PAP machines. It follows people with very high AHI or higher BMI after an Inspire implant.

Age
18 years and older
Sex
All sexes
Disease stage
Severe OSA with 65 ≤ AHI ≤ 100 on a sleep study within 12 months, or moderate to severe OSA (15≤AHI≤100) with a BMI of 32<BMI≤40 kg/m2.
Earlier treatment
Must have failed or not tolerated positive airway pressure (CPAP or BPAP). Failure means AHI > 15 despite PAP. Intolerance means not using it > 5 nights per week, 4 hours per night, or being unwilling to use it.

Main reasons for not taking part

  • Central plus mixed apneas make up more than 25% of the total AHI
  • Airway shape that would stop the stimulation working, such as complete concentric collapse of the soft palate
  • A condition or procedure that harmed nerve control of the upper airway
  • Pregnant or planning pregnancy
  • An implanted device that may interact with the Inspire System, or a terminal illness with life expectancy < 12 months

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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 take part

  • Subject has any condition or procedure that has compromised neurological control of the upper airway
  • Subject has a terminal illness with life expectancy < 12 months
  • 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 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
  • Any other reason the investigator deems the subject is unfit for participation in the study

Where in United States

  • Florida Sleep SpecialistsBradenton, United StatesContact: Barbara JohnsTaking people
  • Rush University Medical CenterChicago, United StatesContact: Mahendra ShahTaking people
  • Colorado ENT & AllergyColorado Springs, United StatesContact: Monica DavisTaking people
  • University of Kansas Medical CenterKansas City, United StatesContact: Bryan HumphreyTaking people
  • University of RochesterRochester, United StatesContact: Paul AllenTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • High AHI

    Following patients with 65\<AHI≤100 events/hr after Inspire Implantation for a period of 5 years

    Treatment: Inspire® UAS System

  • High BMI

    Following patients with 32\<BMI≤40 kg/m2 after Inspire Implantation for a period of 5 years

    Treatment: Inspire® UAS System

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Inspire UAS High AHI/High BMI Post-Approval Study
Plain-language title
Long-term follow-up of the Inspire device for obstructive sleep apneaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
27 March 2026