- ClinicalTrials.gov ID: NCT05508971
- Not accepting healthy volunteers
- UTSW Principal Investigator: RON BENSON MITCHELL
objective
The overall objective of this study is to test the effectiveness of a novel personalized approach to the surgical treatment of OSA in children. It is our central hypothesis that a personalized DISE-directed surgical approach in children with DS will be superior to the recommended first line treatment of AT. To test this hypothesis, we propose an unprecedented randomized controlled trial of DISE-directed surgery vs AT in children with Down syndrome ages 2-18 years with the following specific aims: Aim 1: Compare the physiological outcomes of DISE-directed surgery vs AT in children with DS. Hypothesis 1: DISE-directed surgery will result in a clinically significantly greater improvement in the obstructive apnea-hypopnea index (OAHI) compared to the standard AT intervention. Aim 2: Compare the clinical outcomes of DISE-directed surgery vs AT in children with DS. Hypothesis 2: DISE-directed surgery will result in a clinically significantly greater improvement in disease specific QOL (OSA18) compared to the standard AT intervention.