RECRUITING

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

Conditions

Obstructive Sleep Apnea (OSA)Obstructive Sleep Apnea OSA Inspire AHI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Inspire UAS High AHI/High BMI Post-Approval Study

Quick Facts

Study Start:2025-07-31

Study Completion:2032-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07113288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject is at least 18 years of age; 2. 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; 3. 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). 4. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation; 5. 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; 6. Subject is willing and able to provide informed consent.	1. 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); 2. 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; 3. Subject has any condition or procedure that has compromised neurological control of the upper airway; 4. Subject is unable or does not have the necessary assistance to operate the patient remote; 5. Subject is pregnant or plans to become pregnant; 6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System; 7. Subject has a terminal illness with life expectancy \< 12 months; 8. Any other reason the investigator deems the subject is unfit for participation in the study.

Inclusion Criteria

Exclusion Criteria

1. Subject is at least 18 years of age;
2. 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;
3. 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).
4. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
5. 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;
6. Subject is willing and able to provide informed consent.

1. 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);
2. 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;
3. Subject has any condition or procedure that has compromised neurological control of the upper airway;
4. Subject is unable or does not have the necessary assistance to operate the patient remote;
5. Subject is pregnant or plans to become pregnant;
6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
7. Subject has a terminal illness with life expectancy \< 12 months;
8. Any other reason the investigator deems the subject is unfit for participation in the study.

Contacts and Locations

Study Contact

Gwen Gimmestad

CONTACT

763-392-9966

gwengimmestad@inspiresleep.com

Study Locations (Sites)

Colorado ENT & Allergy

Colorado Springs, Colorado, 80923

United States

Florida Sleep Specialists

Bradenton, Florida, 34209

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

University of Rochester

Rochester, New York, 14642

United States

Collaborators and Investigators

Sponsor: Inspire Medical Systems, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-31

Study Completion Date2032-01-01

Study Record Updates

Study Start Date2025-07-31

Study Completion Date2032-01-01

Terms related to this study

Keywords Provided by Researchers

Obstructive Sleep Apnea
OSA
Inspire
AHI

Additional Relevant MeSH Terms

Obstructive Sleep Apnea (OSA)