Endotype DIrected Treatment for OSA in Down Syndrome

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT07280468
Phase
PHASE4
Status
Recruiting
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Conditions

  • Down Syndrome
  • Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ato-oxy — DRUG
    0.5 mg/kg (max 40 mg) of atomoxetine and 5mg oxybutynin taken nightly.
  • Oxygen — DRUG
    Oxygen via nasal cannula used nightly

Study Details

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. 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.

Key Dates

Start date
Mar 14, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Uniform therapy (ato-oxy)
    All participants receive the combination of atomoxetine and oxybutynin (ato-oxy) once nightly
  • Experimental: Endotype Directed Treatment
    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).

Primary Outcome Measure

obstructive apnea-hypopnea index (oAHI) [ Time Frame: 12 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724
Natalie Provencio-Dean
[email protected]
520-403-6165
University of California San DiegoSan DiegoCalifornia92123
Jasmine Tinoco
[email protected]
858-576-1700
Rakesh Bhattacharjee (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Ignacio Tapia
[email protected]
305-243-6162
Ignacio Tapia (PRINCIPAL_INVESTIGATOR)
Advocate Medical Group Adult Down Syndrome CenterPark RidgeIllinois60068
Alex Albers
[email protected]
920-288-3129
Brian Chicoine (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Ruth Bradford
[email protected]
267-426-5747
Chris Cielo (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tucson, AZ

By research site
University of Arizona· Tucson, AZUniversity of California San Diego· San Diego, CAUniversity of Miami· Miami, FLAdvocate Medical Group Adult Down Syndrome Center· Park Ridge, ILChildren's Hospital of Philadelphia· Philadelphia, PA

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