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Tailored sleep apnea therapy shows promise for down syndrome

NCT ID NCT07280468

Disease control Sponsor: University of Arizona Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This study tests whether matching sleep apnea treatment to the specific cause in each person with Down syndrome works better than a one-size-fits-all approach. 200 children and adults will receive either a combination of two drugs (ato-oxy) or oxygen therapy based on their individual sleep problems. The goal is to improve sleep, quality of life, and thinking skills over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atomoxetine and oxybutynin (ato-oxy) or oxygen
What this could lead to
If successful, this could make sleep apnea treatment more effective for people with Down syndrome by choosing the right therapy for each person.
What could go wrong
This is a Phase 4 study, but it is still early in testing this precision approach. The treatments may not work for everyone, and side effects like dry mouth or urinary issues are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Down syndrome obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Down syndrome Obstructive sleep apnea (OSA)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advocate Medical Group Adult Down Syndrome Center

    RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of California San Diego

    RECRUITING

    San Diego, California, 92123, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

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