Endotype DIrected Treatment for OSA in Down Syndrome
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
| Condition(s) | Obstructive Sleep Apnea (OSA), Down Syndrome |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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 increas |
| Who can participate | 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 depressio |
| Ages | 6 Years |
| Sex | All |
| Lead sponsor | University of Arizona |
| Locations | Tucson, Arizona, United States; San Diego, California, United States; Miami, Florida, United States; Park Ridge, Illinois, United States; Philadelphia, Pennsylvania, United States |
| Start date | 2026-03-14 |
| NCT ID | NCT07280468 |
| Official listing | https://clinicaltrials.gov/study/NCT07280468 |