Families in Arizona, NM, Utah, and So. California: The University of Arizona is seeking participants for a clinical trial of medications to treat obstructive sleep apnea in children age 6-17 with Down syndrome.
This study will investigate the use a combination of atomoxetine (a medication approved by the FDA in children for the treatment of ADHD) and oxybutynin (a medication approved by the FDA in children for overactive bladder). These medications, which have been shown to treat obstructive sleep apnea in a small study of adults without Down syndrome, are thought to treat obstructive sleep apnea by increasing airway muscle strength, which is known to be lower in children with Down syndrome.
The clinical trial will involve completing a total of 3 sleep studies over 3 months and taking study medications for a total of 2 months. Participants should be within driving distance of the University of Arizona in Tucson.
Children may be eligible if they have a diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism) and do not have any of the following:
- currently using and unable to discontinue PAP therapy
- premature birth < 37 weeks estimated gestational age
- seizure disorder requiring current use of medications
- untreated or inadequately treated hypothyroidism
- history of current, untreated depression
- history of liver disease
If you would like more information about the study, please contact Silvia Lopez at firstname.lastname@example.org for further information. Participants will be compensated for their time. This study has been approved by the University of Arizona Institutional Review Board.