Pediatric Down Syndrome Post-Approval Study

Recruiting now · Not applicable

Conditions studied: Pediatric Obstructive Sleep Apnea, Down Syndrome (DS)

In brief

The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.

Key facts

Study ID: NCT06851338
Run by: Inspire Medical Systems, Inc.
People needed: 60
Starts: 2025-02-01
Expected to finish: 2030-05-01
Last updated by the study team: 2025-02-28

Who can join

Age: 13 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Baylor College of Medicine/ Texas Children's Hospital — Houston, Texas, United States (enrolling)
Phoenix Children's Hospital — Phoenix, Arizona, United States
Children's Hospital Orange County — Orange, California, United States
University of South Florida Morsani College of Medicine — Tampa, Florida, United States
Northwell Cohen Children's Hospital — Queens, New York, United States
Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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