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Taking people in United StatesPhase 4

Choosing ato-oxy or oxygen by sleep apnea cause in Down syndrome

Tests ato-oxy or oxygen for sleep apnea in Down syndrome.

Key facts

Who runs it
University of Arizona
Where
Miami, Park Ridge, Philadelphia, San Diego, and Tucson, United StatesSee the 5 sites
Trial code
Registry title
Endotype DIrected Treatment for OSA in Down Syndrome
Status
Recruiting
Phase
Phase 4
People taking part
200 people, planned
Started
14 Mar 2026
Expected to end
Jan 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • ato-oxy
  • Oxygen
Record updated
3 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and adults with Down syndrome who have obstructive sleep apnea (OSA), meaning breathing problems during sleep.

Age
6 years or older
Sex
All sexes can join
Disease stage
Obstructive sleep apnea (OSA) in people with Down syndrome
Earlier treatment
People who currently use PAP therapy (a breathing machine for sleep) regularly cannot join. Regularly means >4 hours per night for 70% of nights in the past 30 days. People taking MAO inhibitor medicines cannot join.

Main reasons for not taking part

  • Trouble emptying the bladder (urinary retention) or a seizure disorder
  • Underactive thyroid (hypothyroidism) that is untreated or not treated well enough
  • Serious brain injury, or current depression that is not treated
  • Past liver disease, except metabolic dysfunction-associated steatotic liver disease
  • Children with very large tonsils (3+ or greater); heart disease patients not cleared by their heart doctor

This trial only enrols participants with Down syndrome. The registry sentence this rests on: 2. Down syndrome diagnosis

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Age 6 years or older
  • Down syndrome diagnosis
  • Any gender or ethnicity
  • Adults without a legally authorized representative must have a caregiver/support person that can co-sign consent and complete study questionnaires

Who cannot take part

  • 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)
  • MAO inhibitor use
  • Seizure disorder
  • 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
  • History of current, untreated depression
  • History of liver disease (not including metabolic dysfunction-associated steatotic liver disease)
  • Urinary retention
  • Untreated or inadequately treated hypothyroidism
  • Significant traumatic brain injury
  • 3+ or greater tonsillar hypertrophy (for children only, no restriction for adults)

Where in United States

  • University of MiamiMiami, United StatesContact: Ignacio TapiaTaking people
  • Advocate Medical Group Adult Down Syndrome CenterPark Ridge, United StatesContact: Alex AlbersTaking people
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Ruth BradfordTaking people
  • University of California San DiegoSan Diego, United StatesContact: Jasmine TinocoTaking people
  • University of ArizonaTucson, United StatesContact: Natalie Provencio-DeanTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Uniform therapy (ato-oxy)Existing treatment, for comparison

    All participants receive the combination of atomoxetine and oxybutynin (ato-oxy) once nightly

    Treatment: ato-oxy

  • Endotype Directed TreatmentTreatment being tested

    Participants receive either atomoxetine and oxybutynin (ato-oxy) or oxygen nightly. Participants receive the treatment expected to be most beneficial to them based on their baseline sleep study and OSA characteristics (OSA endotype).

    Treatment: ato-oxy and Oxygen

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Endotype DIrected Treatment for OSA in Down Syndrome
Plain-language title
Choosing ato-oxy or oxygen by sleep apnea cause in Down syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
3 September 2026