Study of Atomoxetine, Oxybutynin, and Oxygen for Sleep Apnea in Down Syndrome

This study is looking into new ways to treat obstructive sleep apnea (OSA) in people with Down syndrome. OSA is a condition where breathing stops and starts during sleep, which is very common in individuals with Down syndrome and can affect their thinking and quality of life. Current treatments often don't work well or involve surgery. This trial is testing two different approaches: a combination of two medications, atomoxetine and oxybutynin (called "ato-oxy"), or oxygen delivered through a nasal tube. The main goal is to see if these treatments can reduce the number of breathing pauses during sleep after 12 months. You may be able to join if you are 6 years or older and have a diagnosis of Down syndrome.

Study design
This interventional study plans to enroll 200 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, obstructive apnea-hypopnea index (oAHI), is measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07280468

Endotype DIrected Treatment for OSA in Down Syndrome

Recruiting
PHASE4Ages 6+InterventionalTreatment
University of Arizona
~200 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:ato-oxyOxygen

At a glance

Recruiting sites
2 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
obstructive apnea-hypopnea index (oAHI)
Measured over 12 months
Obstructive Sleep Apnea (OSA)
Down Syndrome
5 sites across 5 states
Arizona1
California1
Florida1
Illinois1
Pennsylvania1
  • Daniel Combs, MD · PRINCIPAL_INVESTIGATOR · University of Arizona

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  • obstructive apnea-hypopnea index (oAHI)12 months

    change in number of obstructive apneas and hypopneas per hour on polysomnography from baseline. Decreased oAHI indicates better outcome.