RECRUITING Phase 4 ClinicalTrials.gov

Endotype DIrected Treatment for OSA in Down Syndrome

Sponsor: University of Arizona • ClinicalTrials.gov ID: NCT07280468

Registry updated: 2026-09-03

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Description

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 of life, behavior and cognition at the start of the study and after 12 months of treatment for every participant. The study will also track any treatment side effects for each treatment group.

Interventions

ato-oxy (Drug)
0.5 mg/kg (max 40 mg) of atomoxetine and 5mg oxybutynin taken nightly.
Oxygen (Drug)
Oxygen via nasal cannula used nightly

Eligibility criteria

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)

Conditions

Obstructive Sleep Apnea (OSA) Down Syndrome

Locations

University of Arizona — Tucson, Arizona, United States
University of California San Diego — San Diego, California, United States
University of Miami — Miami, Florida, United States
Advocate Medical Group Adult Down Syndrome Center — Park Ridge, Illinois, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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