Randomized Control Trial of OxygenTherapy in Children and Adolescents with Down Syndrome and Obstructive Sleep Apnea
DOSA (Oxygen Therapy in Down's Syndrome OSA)
What is the goal of the study?
Children who are 5 - 17 years of age with Down's syndrome and obstructive sleep apnea (OSA) and meet the study eligibility criteria will be randomized to conservative care (CT) or oxygen with CT at night for a 6-month period. Conservative care is standard care with sleep positioning, nasal strips, weight management/nutrition counseling. Cognitive testing, echocardiograms, and sleep studies (PSGs) will be done at baseline, 3 months and 6 months post randomization to collect efficacy and safety data. Monthly calls from the research team will assess adherence and provide family support. Adverse events related to the study intervention will be assessed and reported to the study sponsor.
Who can participate in the study?
Please contact the study team listed below to learn more.