RecruitingNCT04457154
Pediatric Post-Approval Registry
Inspire Pediatric Post-Approval Registry
Sponsor
Inspire Medical Systems, Inc.
Enrollment
60 participants
Start Date
Nov 30, 2021
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 21 Years
Inclusion Criteria8
- 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 Criteria8
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DEVICEInspire Upper Airway Stimulation System
Implant of the Inspire Upper Airway Stimulation System
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04457154
Related Trials
Post Market Clinical Follow up of ResMed Mask Systems
NCT052624391 location
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
NCT0722676538 locations
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
NCT0722568647 locations
OSA as a Remote Ischemic Preconditioning in Vascular Surgery
NCT046305351 location
Oropharyngeal Exercises to Treat Obstructive Sleep Apnea
NCT056780881 location