Status:
COMPLETED
Medications for Obstructive Sleep Apnea In Children With Down Syndrome
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obstructive Sleep Apnea
Down Syndrome
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
This is a randomized, double blind, cross-over study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with DS and OSA documented by polysomnography (PSG). Participants will recei...
Eligibility Criteria
Inclusion
- Male or female participants between 6 to 17 years of age, inclusive, at the Screening Visit. Enrollment will be stratified to ensure equal representation of children age 6-12 and age 13-17. No more than 14 subjects will be randomized for each age group.
- Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism)
Exclusion
- Hypoxemia independent of respiratory events on polysomnography (≥5 minutes with oxygen saturation \<90%)
- Presence of central sleep apnea on polysomnography (central AHI ≥ 5)
- 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 report)
- MAO inhibitor use
- Urinary retention
- Prematurity \< 37 weeks estimated gestational age
- Seizure disorder
- Untreated or inadequately treated hypothyroidism
- Significant traumatic brain injury
- Congenital heart disease and not cleared to participate by the patient's cardiologist
- History of current, untreated depression
- History of liver disease
- 3+ or greater tonsillar hypertrophy.
Key Trial Info
Start Date :
October 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04115878
Start Date
October 21 2020
End Date
December 30 2022
Last Update
August 19 2025
Active Locations (1)
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1
University of Arizona
Tucson, Arizona, United States, 85721