NCT07280468 Endotype DIrected Treatment for OSA in Down Syndrome
| NCT ID | NCT07280468 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Arizona |
| Condition | Obstructive Sleep Apnea (OSA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-03-14 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2026-03-14 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
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)
Contact & Investigator
Daniel Combs, MD
PRINCIPAL INVESTIGATOR
University of Arizona
Frequently Asked Questions
Who can join the NCT07280468 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Obstructive Sleep Apnea (OSA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07280468 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07280468 currently recruiting?
Yes, NCT07280468 is actively recruiting participants. Contact the research team at nataliep@arizona.edu for enrollment information.
Where is the NCT07280468 trial being conducted?
This trial is being conducted at Tucson, United States, San Diego, United States, Miami, United States, Park Ridge, United States and 1 additional location.
Who is sponsoring the NCT07280468 clinical trial?
NCT07280468 is sponsored by University of Arizona. The principal investigator is Daniel Combs, MD at University of Arizona. The trial plans to enroll 200 participants.