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

NCT07113288 | Recruiting FDA Device

• 1 other identifier: 2023-005
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

Obstructive Sleep Apnea; OSA; Inspire; AHI

Outcome Measures

Primary Outcomes (1)

• Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability)

  Procedure-related Adverse Events; Device-related Adverse Events

  5 years post-implant

Secondary Outcomes (5)

• Change in Apnea Hypopnea Index Over Time

  5 years post-implant

• Body Mass Index

  5 years post-implant

• Change in Oxygen Desaturation Index (ODI) Over Time

  5 years post-implant

• Change in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) Over Time

  5 years post-implant

• Change in Epworth Sleepiness Scale (ESS) Over Time

  5 years post-implant

Other Outcomes (2)

• Evaluation of Therapy Usage and Adherence Over Time

  5 years post-implant

• Change in Patient Satisfaction Over Time

  5 years post-implant

Study Arms (2)

High AHI

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

Device: Inspire® UAS System

High BMI

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

Device: Inspire® UAS System

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.

High AHI; High BMI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A post-market sample selected from enrolling center's real-world patient population

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inspire Medical Systems, Inc.: lead

Study Sites (5)

Colorado ENT & Allergy

Colorado Springs, Colorado, 80923, United States

RECRUITING

Florida Sleep Specialists

Bradenton, Florida, 34209, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Gwen Gimmestad

CONTACT

763-392-9966; gwengimmestad@inspiresleep.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: August 8, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): January 1, 2032
• Last Updated: March 27, 2026

Record last verified: 2025-08

Locations

US (5)