Inspire Pediatric Post-Approval Registry
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.
• 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.