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Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

Exploring new treatment for Down Syndrome and sleep apnea.

Recruiting
10-21 years
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study explores the effects of a treatment called Inspire Upper Airway Stimulation (UAS) in young people with Down syndrome and obstructive sleep apnea (OSA). OSA is a condition where breathing stops and starts during sleep. The Inspire UAS is a device implanted to help with breathing during sleep. Participants should be between 10-21 years old, have Down syndrome, and have already had their tonsils and adenoids removed. The study lasts 12 months, and involves five visits, including sleep studies to monitor changes.

Key Points:

  • Study duration: 12 months with five study visits.
  • Must be willing to have the device implanted and attend follow-up visits.
  • Compensation details are not specified in the study information.

Before joining, participants will be checked for eligibility through medical records, a sleep study, and a test called drug-induced sleep endoscopy (DISE). Risks include surgery for the implant and potential side effects of the device. Participants should be able to communicate any discomfort to their caregivers. This study aims to see if the device improves thinking skills and language abilities.

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Study details
    Down Syndrome
    Obstructive Sleep Apnea

NCT04801771

Inspire Medical Systems, Inc.

1 April 2025

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