RecruitingPediatric Obstructive Sleep ApneaDown Syndrome (DS)
Pediatric Down Syndrome Post-Approval Study
Eligible age
13–18 yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Inspire Medical Systems, Inc.
You may qualify if…
- ✓ 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 ≥ 10 and ≤ 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG);
- ✓ 4. Patient has documented failure of, or intolerance to, positive airway pressure therapies (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 other alternative/adjunctive therapies;
- ✓ 7. 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…
- ✕ 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 upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
- ✕ 3. Patient has any condition or procedure that has compromised neurological control of the upper airway;
- ✕ 4. Patient, or their parent/guardian, is unable or does not have the necessary assistance 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 interaction with the Inspire system;
- ✕ 7. Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling;
- ✕ 8. Patient has a terminal illness with life expectancy of less than 12 months;
Where it's recruiting
Source: ClinicalTrials.gov · NCT06851338 · last updated 2025-02-28