Auto-Titrating Oral Appliance for Sleep Disordered Breathing

Project Summary/Abstract Rush River Research Corp. (RRR) proposes to develop an auto-titrating oral appliance that fits fully-in-the-mouth for Sleep Disordered Breathing (SDB) therapy. SDB, resulting from airway obstruction, is directly linked to the four most costly diseases in the United States: heart disease, diabetes, obesity, and cancer. Research has shown that SBD sufferers are three times more likely to die prematurely. Current therapeutic devices, such as CPAP, surgery, and traditional non-auto-titrating oral appliances are the most common therapy approaches to SBD, with CPAP being considered the gold standard. Despite 30 years of CPAP commercialization, 90% of the potential U.S. and worldwide markets for SDB therapy remain untreated. Lack of toleration of CPAP leads to poor compliance among users. Oral mandibular advancement appliances typically provided, fit, and titrated by dentists are often an alternative for patients with unsuccessful experiences with CPAP or with mild SDB. However, the titration process can require multiple visits to the dentist over several months and the dentists lack feedback on compliance and efficacy during and after titration. Inflammation of the temporomandibular joint (TMJ) resulting from the fixed and continuous artificial advancement of the mandible can also occur. The proposed connected auto-titrating, SDB sensing, oral appliance can mitigate issues with the titration process and be optimized to provide minimum therapy necessary to improve user safety and comfort. RRR and collaborators propose to show feasibility of a fully-in-the-mouth micro manipulating oral appliance by developing a prototype appliance and demonstrating functionality in an overnight human study of people suffering from SDB. RRR has assembled a highly qualified team of Sleep and Oral Medicine experts and experienced medical device designers to achieve these goals.