NCT04457154 · Inspire Medical Systems, Inc.
Pediatric Post-Approval Registry
What this study is about
This registry is a forward-looking, multi-center, single-treatment group$1 study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.
View original scientific description
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject is between 18 and 21 years of age;
- Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;
- Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;
- Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;
- Subject has followed standard of care in considering all other alternative/adjunct therapies;
- 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 registry;
- Subject is willing and able to provide informed consent.
Exclusion criteria
- Subject has a combination of central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI);
- 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 registry.
Where
- Aurora, Colorado
- Atlanta, Georgia
- Durham, North Carolina
- Cincinnati, Ohio
- Philadelphia, Pennsylvania
- Sewickley, Pennsylvania
- Dallas, Texas
- Norfolk, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 25, 2025 · Source of record for eligibility and locations