Development and Validation of Mechanically Compliant Wearable Monitoring Systems for Swallowing Function and Disorders

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Rural areas often experience shortages of medical professionals and technologies. Such shortages significantly affect patient health and outcomes, justifying investments in tele-rehabilitation technology to deliver these services remotely. Modern technologies enable the use of portable monitoring systems, facilitating clinicians to remotely collect biofeedback signals for rehabilitation practices and enabling patients to use real-time biofeedback. However, existing devices suffer from rigid or semi-flexible platforms, which are not suited for interfacing with the soft, curvilinear, and dynamic parts of the human body (e.g., the submental (under the chin) and intraoral areas). This often results in poor data acquisition and in discomfort, thereby affecting patient compliance. Moreover, poor treatment compliance is identified as a critical barrier to rehabilitation, and is primarily attributed to expensive, difficult-to-use or limited availability of equipment/devices, and inability to physically access treatment. This team's long-term goal is to provide a complete set of advanced wearable devices that can be easily and accurately utilized for day-to-day tele-rehabilitation needs. The objective of this project is to develop and start validating a collection of inexpensive soft, thin monitoring systems that can perfectly fit into/on the human body, and then wirelessly provide accurate real-time data to patients and clinicians. Two curvilinear and structurally complex areas of the human body, the submental and intraoral areas, will be targeted for the development of these novel, wearable transducers. Measurements from these areas are essential during rehabilitation of swallowing, a vital body function that is used as the model for this proposal. Swallowing disorders (dysphagia) are common in many diseases (e.g., head and neck cancer, stroke, etc.) and significantly affect health, quality of life, and social integration. To accurately monitor swallowing signals, intimate attachment of sensors to the anatomically challenging head/neck skin and intra- oral environment is essential. To attain the stated objective, the following specific aims are proposed: 1) to develop and conduct benchtop testing of a wireless soft, thin sensor patch tailored for submental muscle monitoring, 2) to develop and conduct benchtop testing of a wireless palatal plate sensor tailored for intraoral pressure/movement monitoring, and 3) to conduct iterative pre-clinical experiments in healthy adults to validate the safety, ease-of-use/comfort, and signal quality of the sensors during swallowing tasks and exercises. The proposed research is innovative, as it will develop novel, wearable tele-monitoring systems that are tailored for two challenging areas anatomically. This contribution will be significant because it will offer a first-of-its-kind, mechanically compliant, inexpensive, and reliable wearable system for swallowing signals monitoring. This work will then form the basis for developing dysphagia tele-rehabilitation protocols and completing a follow-up clinical trial. Upon project completion, a foundational platform will have been established that can be extended to a range of disorders, including speech and oral sensorimotor disorders.