Plain-English translation of NCT06851338 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing the Inspire Upper Airway Stimulation (UAS) system, a small device implanted during surgery that gently stimulates the airway muscles to keep them open during sleep. The study will follow 60 teenagers with Down syndrome and severe sleep apnea for 5 years after they receive the implant, tracking whether the treatment is safe and effective and how much it improves their sleep and quality of life.
Many teenagers with Down syndrome suffer from severe sleep apnea, which disrupts their sleep and can affect their health and development. Standard treatments like CPAP machines or surgery don't work for all patients, so researchers want to see if this implanted device can help teenagers who haven't responded to other options.
You likely qualify if…
You likely don't qualify if…
If you join, you'll first undergo testing including an in-lab sleep study, a surgical consultation, and an endoscopy (a small camera procedure) to confirm you're a good candidate. If eligible, you'll have surgery to implant the device. Over the next 5 years, you'll visit the clinic multiple times for check-ups, sleep studies, and questionnaires to assess how well the device is working, whether you're using it regularly, and how your sleep and quality of life have improved.
AI-generated summary from trial data · Jun 3, 2026 · Not medical advice
United States