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NCT07280468 · ClinicalTrials.gov registry record · Phase 4
Endotype DIrected Treatment for OSA in Down Syndrome
A Phase 4 study, sponsored by University of Arizona.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
NCT07280468: Recruiting Phase 4 study, sponsored by University of Arizona.
NCT07280468 is a Phase 4 study that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 200 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07280468, a Phase 4 study, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
Study 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.
Primary Outcome
change in number of obstructive apneas and hypopneas per hour on polysomnography from baseline. Decreased oAHI indicates better outcome.
Interventions
- DRUG Oxygen
- DRUG ato-oxy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2026-03-14 |
| Est. Completion | 2030-01 |
| Phase | Phase 4 |
What NCT07280468 shows while recruiting
NCT07280468 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Oxygen is the first listed.
NCT07280468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07280468 about?
NCT07280468 is a clinical study titled "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 difficu...
What is the current status of trial NCT07280468?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2026-03-14. Estimated completion is 2030-01.
What interventions are being tested in trial NCT07280468?
The interventions under investigation include: Oxygen (DRUG), ato-oxy (DRUG).
Who is sponsoring clinical trial NCT07280468?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07280468's enrollment target sits among peer trials
200 407th of 2000 higher than 1,556 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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