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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Baylor College of Medicine/ Texas Children's Hospital
  Houston, Texas, United States Recruiting
• 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

Study contacts

• Study coordinator: Angela Chapin, Sr. Clinical Study Manager
• Email: angelachapin@inspiresleep.com
• Phone: 763.392.7222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.