RecruitingNCT07113288

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

Inspire UAS High AHI/High BMI Post-Approval Study

Sponsor

Inspire Medical Systems, Inc.

Enrollment

70 participants

Start Date

Jul 31, 2025

Study Type

OBSERVATIONAL

Conditions

Obstructive Sleep Apnea (OSA)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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.

Exclusion Criteria8

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.

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Interventions

DEVICEInspire® UAS System

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.