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Could a sleep apnea drug boost brain power in kids with down syndrome?

NCT ID NCT05933603

Symptom relief 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of two medicines (atomoxetine and oxybutynin) given at bedtime for 6 months to children aged 6-17 with Down syndrome and obstructive sleep apnea. The goal is to see if the treatment improves sleep quality and thinking skills. About 36 children will take part, and their sleep and cognitive function will be measured before and after treatment.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

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

Started

Sep 2023

Expected to finish

Jun 2026

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 to 17 years

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. Male or female participants between 6 to 17 years of age, inclusive, at the Screening Visit. 2. Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism) Exclusion Criteria: 1. Presence of central sleep apnea on polysomnography (central AHI ≥ 5) 2. Currently using and adherent to positive airway pressure therapy (\>4 hours per night for 70% of nights in the past 30 days based on device download or parent report) 3. Monoamine oxidase inhibitor use 4. Urinary retention 5. Prematurity \< 32 weeks estimated gestational age 6. Seizure disorder 7. Untreated or inadequately treated hypothyroidism 8. Significant traumatic brain injury 9. Congenital heart disease and not cleared to participate by the patient's cardiologist 10. History of current, untreated depression 11. History of liver disease 12. 3+ or greater tonsillar hypertrophy 13. Positive urine pregnancy test 14. Hypoxemia independent of respiratory events on baseline polysomnography (≥5 minutes with oxygen saturation \<90%) 15. Presence of central sleep apnea on baseline polysomnography (central AHI ≥ 5) 3\. Absence of OSA defined as total AHI \<5 on baseline polysomnography

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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

Contacts and locations

Locations

  • University of Arizona

    Tucson, Arizona, 86721, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.