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

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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