Pediatric Down Syndrome Post-Approval Study

Inclusion Criteria:

1. Patient has been diagnosed with Down syndrome;

2. Patient is 13-18 years of age;

3. Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of ≥ 10and ≤ 50 based on a recent (within 6 months of enrollment) qualified in-lab sleepstudy (PSG);

4. Patient has documented failure of, or intolerance to, positive airway pressuretherapies (such as CPAP or BiPAP) despite attempts to improve compliance;

5. Patient is contraindicated for, or not effectively treated by, adenotonsillectomy;

6. Treatment of patient's OSA has followed standard of care in considering all otheralternative/adjunctive therapies;

7. Patient, and their parents/guardians, is willing to have stimulation hardwarepermanently implanted, and be willing to participate in follow-up visits,postoperative in-lab sleep studies (PSGs), and questionnaire completion.

Exclusion Criteria:

1. Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas > 25% of the total apnea-hypopnea index (AHI);

2. Patient has any anatomical finding that would compromise the performance of upperairway stimulation, such as the presence of complete concentric collapse of the softpalate;

3. Patient has any condition or procedure that has compromised neurological control ofthe upper airway;

4. Patient, or their parent/guardian, is unable or does not have the necessaryassistance to operate the patient remote;

5. Patient is pregnant or plans to become pregnant;

6. Patient has an implantable device that may be susceptible to unintended interactionwith the Inspire system;

7. Patient will require magnetic resonance imaging (MRI) other than what is specifiedin the MR conditional labeling;

8. Patient has a terminal illness with life expectancy of less than 12 months;

9. Any other reason the investigator deems the patient is unfit for participation inthe study.