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

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
Inspire Medical Systems, Inc.
Study ID
NCT07113288
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inspire® UAS System — DEVICE
    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 Details

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.

Key Dates

First listed
Aug 8, 2025
Start date
Jul 31, 2025
Status verified
Aug 2025
Primary completion
Jan 1, 2032
Completion
Jan 1, 2032

Study Design

Enrollment
70 participants (estimated)

Arms

  • Arm: High AHI
    Following patients with 65\<AHI≤100 events/hr after Inspire Implantation for a period of 5 years
  • Arm: High BMI
    Following patients with 32\<BMI≤40 kg/m2 after Inspire Implantation for a period of 5 years

Primary Outcome Measure

Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability) [ Time Frame: 5 years post-implant ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Colorado ENT & AllergyColorado SpringsColorado80923
Monica Davis
[email protected]
Dr. Nicholas Beckmann, DO (PRINCIPAL_INVESTIGATOR)
Florida Sleep SpecialistsBradentonFlorida34209
Barbara Johns
[email protected]
Jeremy McConnell, MD (PRINCIPAL_INVESTIGATOR)
Rush University Medical CenterChicagoIllinois60612
Mahendra Shah
[email protected]
Michael Hutz, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66160
Bryan Humphrey
[email protected]
Damien Stevens, MD (PRINCIPAL_INVESTIGATOR)
University of RochesterRochesterNew York14642
Sveta Karelsky, MD (PRINCIPAL_INVESTIGATOR)

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Colorado ENT & Allergy· Colorado Springs, COFlorida Sleep Specialists· Bradenton, FLRush University Medical Center· Chicago, ILUniversity of Kansas Medical Center· Kansas City, KSUniversity of Rochester· Rochester, NY

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