Assessing Inspire therapy for adolescents with Down syndrome and severe sleep apnea

Pediatric Down Syndrome Post-Approval Study

This study is testing a new sleep therapy for teenagers with Down syndrome and severe sleep apnea to see if it helps them sleep better and improves their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 13 Years to 18 Years
• Sex: All
• Sponsor: Inspire Medical Systems, Inc. (Industry-sponsored)
• Locations: 6 sites (Phoenix, Arizona and 5 other locations)
• Trial ID: NCT06851338 on ClinicalTrials.gov

What this trial studies

This research evaluates the ongoing safety and effectiveness of the Inspire Upper Airway Stimulation (UAS) system in adolescents and young adults aged 13-18 with Down syndrome and severe obstructive sleep apnea. The study will follow 60 participants over a 5-year period after the implant, collecting data on safety, sleep data, therapy usage, and quality of life at multiple follow-up visits. Participants must meet specific eligibility criteria, including documented failure of other treatments for their condition. The study is conducted across at least five clinical centers in the United States.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 13-18 with Down syndrome and severe obstructive sleep apnea who have not responded to other treatments.

Not a fit: Patients with central or mixed apneas making up more than 25% of their sleep study results may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for adolescents with Down syndrome suffering from severe obstructive sleep apnea.

How similar studies have performed: While the Inspire therapy has been studied in adults, this specific application in the pediatric Down syndrome population is novel and has not been extensively tested.

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.

Where this trial is running

Phoenix, Arizona and 5 other locations

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

Study contacts

• Study coordinator: Angela Chapin, Sr. Clinical Study Manager

Conditions Pediatric Obstructive Sleep Apnea; Down Syndrome; Pediatrics; OSA; Pediatrics OSA; Obstructive Sleep Apnea; Long-term follow-up; Post Approval Study