Pediatric Down Syndrome Post-Approval Study

Launched by INSPIRE MEDICAL SYSTEMS, INC. · Feb 24, 2025

Keywords

ClinConnect Summary

The Pediatric Down Syndrome Post-Approval Study is a research trial focused on understanding how safe and effective the Inspire therapy is for teenagers and young adults aged 13 to 18 with Down syndrome who have severe obstructive sleep apnea (OSA). Sleep apnea is a condition that causes breathing problems during sleep, and Inspire therapy is a treatment that helps keep the airway open. This study is important because it aims to assess the ongoing safety and effectiveness of this therapy in a specific group of patients who may not have responded well to other treatments.

To participate in the study, individuals must have a diagnosis of Down syndrome and severe OSA, meaning they have a certain number of breathing pauses during sleep. Additionally, they should have tried other treatments like CPAP machines without success. It's also necessary for participants and their guardians to agree to have a small device surgically implanted to help with breathing. Participants can expect follow-up visits and sleep studies to monitor their progress. It's essential to know that there are some reasons a person might not be eligible for the study, such as having certain medical conditions or needing other treatments that could interfere with the Inspire system.

Gender

ALL

Eligibility criteria

• 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 ≥ 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.
• 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 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;
• • 9. Any other reason the investigator deems the patient is unfit for participation in the study.