Pediatric Down Syndrome Post-Approval Study

Inclusion criteria

• Patient has been diagnosed with Down syndrome;
• Patient is 13-18 years of age;
• Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of ≥ 10 and ≤ 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG);
• Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance;
• Patient is contraindicated for, or not effectively treated by, adenotonsillectomy;
• Treatment of patient's OSA has followed standard of care in considering all other alternative/adjunctive therapies;
• Patient, and their parents/guardians, is willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative in-lab sleep studies (PSGs), and questionnaire completion.

Exclusion criteria

• Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI);
• Patient 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;
• Patient has any condition or procedure that has compromised neurological control of the upper airway;
• Patient, or their parent/guardian, is unable or does not have the necessary assistance to operate the patient remote;
• Patient is pregnant or plans to become pregnant;
• Patient has an implantable device that may be susceptible to unintended interaction with the Inspire system;
• Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling;
• Patient has a terminal illness with life expectancy of less than 12 months;
• Any other reason the investigator deems the patient is unfit for participation in the study.