Phase 2 Study of Oxygen Therapy During Sleep in Children and Adolescents with Down Syndrome and Moderate to Severe Obstructive Sleep Apnea

What this Trial Is About

Researchers are evaluating whether oxygen supplementation during sleep can improve working memory and other related clinical and patient-reported outcomes in children with Down Syndrome who have moderate to severe Obstructive Sleep Apnea OSA. This randomized, single-blind Phase 2 clinical trial aims to compare the effects of oxygen therapy on cognition, behavior, quality of life, heart structure and function, and sleep patterns in this group. Children participating in the study will be randomly assigned to one of two groups one receiving nocturnal oxygen therapy along with materials on healthy sleep habits, diet, and nasal dilators, and the other receiving only the supportive care materials without oxygen therapy. The study includes an initial screening with polysomnography PSG tests to assess sleep apnea severity and responsiveness to oxygen. Assessments will be repeated after 3 and 6 months, including a follow-up PSG and neurocognitive testing. During the study, children and their caregivers will take part in various evaluations such as wrist actigraphy to monitor sleep, echocardiography to examine heart function, neuropsychological tests, physical exams, and blood draws. Caregivers will complete questionnaires about the childs emotional, physical, social, and school functioning, as well as sleep quality and behavior. The primary outcomes include executive function working memory scores measured at the start and end of the 6-month period. The total participation duration is 6 months, with careful monitoring of sleep and cognitive changes throughout.

Down Syndrome Obstructive Sleep Apnea