Endotype-directed treatment for obstructive sleep apnea in people with Down syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Obstructive sleep apnea is very common in people with Down syndrome and current treatments (surgery, PAP) often have limited benefit or poor adherence. This Phase 4 interventional study randomizes participants to two approaches: one group receives atomoxetine-plus-oxybutynin (ato-oxy) universally, while the other group receives endotype-directed therapy that assigns ato-oxy or supplemental oxygen based on individual breathing characteristics. Eligible participants are people with Down syndrome aged 6 years and older with OSA and without key exclusion conditions such as active seizure disorder or untreated hypothyroidism. The trial is conducted at three academic centers and will measure sleep breathing outcomes as well as cognition and quality-of-life measures.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of Arizona
  Tucson, Arizona, United States Recruiting
• University of California San Diego
  San Diego, California, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• Advocate Medical Group Adult Down Syndrome Center
  Park Ridge, Illinois, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Daniel Combs, MD — University of Arizona
• Study coordinator: Natalie Provencio-Dean
• Email: nataliep@arizona.edu
• Phone: 520-403-6165

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.