Pediatric Post-Approval Registry
ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-21
SponsorInspire Medical Systems, Inc.
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Inspire Upper Airway Stimulation System
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov