Manual Control of the Upper Esophageal Sphincter

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DESCRIPTION (provided by applicant): Dysphagia, or difficulty swallowing, is a devastating disorder that affects over 10 million Americans each year. Untreated dysphagia can lead to dehydration, malnutrition, aspiration pneumonia, and death. The overall goal of this project is to develop innovative, new treatment options for patients with profound dysphagia via clinical and translational research. Although there have been great advances in medical devices for other organ systems, there is currently no device available to assist with the act of deglutition. Current therapeutic options include swallowing therapy, diet modification, non-oral feeding and invasive surgery. Regardless of our best efforts, these treatments fail in a significant percentage of individuals. The particular hypothesis of this proposal is that long-term profound oropharyngeal dysphagia (OPD) can be treated by manually opening the upper esophageal sphincter (UES). The hypothesis will be tested with an ovine model of OPD and a swallow expansion device that manually opens the UES. The specific aims of the proposal are to determine: 1) the force necessary to maximally open the UES by pulling the cricoid cartilage anteriorly; 2) sustained improvement in swallowing by manual opening of the UES with the swallow expansion device; 3) damage to the cricoid cartilage or adjacent tissue and organ systems as evidenced by injury or infection with use of the swallow expansion; and 4) safe removal of the swallow expansion device without damage to the cricoid cartilage or adjacent tissues. At the completion of these studies, it will have been rigorously determined whether manual opening of the UES is safe and efficacious for treating OPD. Results from this proposal will impact the research field through increased understanding of how the cricoid cartilage responds to the biomechanical force necessary to treat OPD, leading to innovative and optimally designed therapy. If the results are positive, this investigation will form the basis for Phase I human clinical trials.