Image

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

Exploring nerve stimulation effects on cognition in Down Syndrome and sleep apnea.

Recruiting
10-21 years
All
Phase 3

Study Purpose: This research looks at how a treatment called the Inspire Upper Airway Stimulation (UAS) System helps young people with Down syndrome and sleep apnea. Sleep apnea causes breathing to stop and start during sleep. The study checks if the treatment helps thinking skills (cognition) and speaking abilities.

What Will Happen: 57 young people aged 10-21 will have a small device implanted to help with breathing. They will be monitored for one year. Participants will need to visit the lab five times and do sleep studies and language tests. Before the implant, they will answer questions about their life and take tests. After the implant, they will have more tests at 6 and 12 months.

Eligibility: Participants must have Down syndrome, be aged 10-21, and have had their tonsils removed. They must have severe sleep apnea and be unable to use other treatments. Parents and children must speak English and agree to visits and tests.

  • Study lasts for 12 months with 5 visits.
  • Participants must be okay with having a small device implanted.
  • Participants will not be able to join if they have other major health issues.
Study details
    Down Syndrome
    Obstructive Sleep Apnea

NCT04801771

Inspire Medical Systems, Inc.

5 January 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

  Other languages supported:

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.