Feasibility of Two Proposed Efficacy Studies

Nova Southeastern University, Davie, Florida, USA

Objective Feasibility findings for two study proposals are reported. Both investigate efficacy of Prolonged Nasal Cul-de-Sac with High Pressure Speech Acts (PiNCH therapy) on velopharyngeal (VP) function with pre-peri- and post therapy imaging. One uses videofluoroscopy and the other, nasopharyngoscopy. Background VP inactivity /“surrender,” occurs in the absence of positive pressure intraorally, e.g., nasal, glottal and pharyngeal sounds, cleft palate, fistula and VP inadequacy. A structural VP gap is exacerbated by the presence of VP surrender. The extensiveness of VP surgery is determined by VP gap size. The more extensive the surgery, the greater are the risks of serious complications such as OSA. P.i.N.C.H.therapy aims at reducing the size of the surrender component of the VP gap so that surgery addresses only the structural component. That way, extensiveness of surgery and its potential complications are reduced. Method Literature reviews, interviews and communication with engineers, a leading manufacturer and voice specialists were conducted. Results Nasopharyngoscopy as a peri-PiNCH evaluation tool was non-feasible in terms of availability and accessibility, and potentially feasible in terms of cost and expertise. Videofluoroscopy as a pre-peri and post evaluation tool was determined to be potentially safe if temporal measures were taken, affordable and accessible. Conclusion Investigating the efficacy of PiNCH therapy is a worthwhile endeavor as the therapy may reduce the extensiveness of VP surgery and consequent complications. Using videofluoroscopy is a feasible method for pre-peri and post therapy study, as the benefits would outweigh the risks. Grants None