OSA is very common in people with Down syndrome, and current treatments don’t work well enough — the standard medication combination used in this study has been shown to reduce OSA severity by about 50%. This study will test whether matching the right treatment to the specific reason a person has OSA can improve results even more.

Participants may be eligible for this study if they meet the following criteria.

Inclusion Criteria:

• Children (age 6 years or older) and adults
• Individual with Down syndrome
• No history of seizure disorder, untreated or inadequately treated hypothyroidism or history of current, untreated depression
• Do not use a CPAP most nights
• Able to attend study visits in San Diego, Tucson, Chicago, Philadelphia or Miami

• Complete an overnight sleep study at the start of the study to confirm you have OSA. (If you don’t have OSA, you won’t continue in the study.)
• Depending on which study group you’re in, use the study treatment — either the combination medication (atomoxetine and oxybutynin) or oxygen therapy — every night for 12 months.
• Complete a cognitive assessment that involves playing games.
• Your parent or support person will fill out several questionnaires.
• Check in by phone about once a month so the study team can monitor for any side effects.
• Return for a second overnight sleep study on your last night of taking the medication, about a year after your first visit.

In total, participation involves 2 in-person visits about a year apart and 2 overnight stays in the sleep lab.

Yes, participants will receive up to $400 for their time and participation, and travel reimbursement up to $200. Sleep studies and study treatment are provided at no additional cost. Transportation is not provided, so please plan accordingly.

There is no cost for participation in our research study.