Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome (MOSAIC)
Obstructive Sleep Apnea, Down Syndrome
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria: Male or female participants between 6 to 17 years of age, inclusive, at the Screening Visit. Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism) Exclusion Criteria: Presence of central sleep apnea on polysomnography (central AHI ≥ 5) 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) Monoamine oxidase inhibitor use Urinary retention Prematurity < 32 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 Positive urine pregnancy test Hypoxemia independent of respiratory events on baseline polysomnography (≥5 minutes with oxygen saturation <90%) Presence of central sleep apnea on baseline polysomnography (central AHI ≥ 5) 3. Absence of OSA defined as total AHI <5 on baseline polysomnography
Sites / Locations
- University of ArizonaRecruiting
Arms of the Study
Arm 1
Experimental
Ato-oxy
0.5 mg/kg (max 40 mg) atomoxetine and 5 mg oxybutynin