Condition: Obstructive Sleep Apnea (OSA) · Down Syndrome · Sponsor: University of Arizona
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. In the first group, everyone will be treated with ato-oxy. In the second group, a precision medicine approach will be used to assign participants to either ato-oxy or oxygen therapy, based on the specific reasons they have OSA. The research team will enroll 200 children (age 6-17 years old) and adults with Down syndrome and OSA from five sites across the country. Half of participants will randomly receive ato-oxy while the other will receive either oxygen or ato-oxy dependent upon which treatment would be expected to work better for them. The research team will measure OSA severity, quality…
This description comes directly from the study's public registry record.
Natalie Provencio-Dean · 520-403-6165 · nataliep@arizona.edu
Always discuss trial participation with your own doctor first.
| University of Arizona | Tucson, Arizona, United States | Recruiting |
| University of California San Diego | San Diego, California, United States | Not Yet Recruiting |
| University of Miami | Miami, Florida, United States | Not Yet Recruiting |
| Advocate Medical Group Adult Down Syndrome Center | Park Ridge, Illinois, United States | Not Yet Recruiting |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07280468