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Endotype DIrected Treatment for OSA in Down Syndrome

RecruitingPhase 4Ages 6 Years - anyAllUniversity of Arizona
NCT07280468 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Down syndrome is the most common genetic cause of intellectual disability. People with Down syndrome often have obstructive sleep apnea (OSA), a condition where people have difficulties with breathing while asleep. OSA can lead to poor sleep, worse quality of life, behavior problems and more difficulties with thinking ("cognitive impairment"). Current treatments for OSA in people with Down syndrome are not very effective or require surgery. The combination of 2 medications, atomoxetine and oxybutynin ("ato-oxy") is a promising treatment for OSA in people with Down syndrome, but ato-oxy does not work for everyone with Down syndrome. Similarly, oxygen is effective for OSA in some people, but does not work for everyone. This study will evaluate the use a precision medicine approach to increase the effectiveness of OSA treatment in people with Down syndrome. The study will compare two groups

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 6 years or older 2. Down syndrome diagnosis 3. Any gender or ethnicity 4. Adults without a legally authorized representative must have a caregiver/support person that can co-sign consent and complete study questionnaires. Exclusion Criteria: 1. Currently using and adherent to PAP therapy (\>4 hours per night for 70% of nights in the past 30 days based on device download or parent/caregiver report) 2. MAO inhibitor use 3. Urinary retention 4. Seizure disorder 5. Untreated or inadequately treated hypothyroidism 6. Significant traumatic brain injury 7. Not cleared to participate in the study by their cardiologist for individuals with congenital heart disease requiring follow up with cardiology at least once in the past year 8. History of current, untreated depression 9. History of liver disease (not including metabolic dysfunction-associated steatotic liver disease) 10. 3+ or greater tonsillar hypertrophy (for children only, no restriction for adults)
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What it tests

  • ato-oxy
  • Oxygen
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Where

5 sites
University of Arizona
Tucson, United States
University of California San Diego
San Diego, United States
University of Miami
Miami, United States
Advocate Medical Group Adult Down Syndrome Center
Park Ridge, United States
Children's Hospital of Philadelphia
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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