Project Summary/Abstract This administrative supplement will allow implementation of data management systems to facilitate FDA 21 CFR part 11 compliant electronic systems. These systems will greatly facilitate data sharing and transfer with FDA when pursuing medical device approval. This administrative supplement additionally requests funds for regulatory support for Q submission meetings and ongoing correspondence with Federal Drug Administration. The study team is receiving partial internal support from the Michigan Institute for Clinical & Health Research, but additionally requires further expertise from third party regulatory consultation. The supplement requests additional funds for finalizing biocompatibility testing and cleaning protocols. Finally, important to the mission of equity and inclusion, there are requested funds for translational document support to facilitate Non-English speaking participants and families to participate in the study. Our institutions clinical translational services is able to help with extremely low numbers of participants, though stated could not support beyond this, recommending third party assistance. These supplemental funds are directly in accord with NIH data sharing and management initiatives. The additional funds will more effectively allow interaction and preparedness for FDA approval procedures, ultimately optimizing the value of the research to patients and families. Additionally, enhancing our ability to include as many patients from Non-English speaking backgrounds directly addresses a key INCLUDE priority for diversity, equity, and inclusion.

Project Narrative Children with HUAO have a high prevalence of severe obstructive sleep apnea, which if not treated has significant clinical consequence. Available treatment approaches, such as surgery and positive airway pressure, show limited efficacy and adherence, respectively. Our multidisciplinary team has developed and now proposes to further test a non-surgical, well-tolerated nasopharyngeal airway device that in initial patients has resolved even extremely severe obstructive sleep apnea, and improved patient and family quality of life.