PFI-AIR-TT: Wearable Sleepwear for Quantitative Prognostication and Noninvasive Therapy of Obstructive Sleep Apnea
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This PFI: AIR Technology Translation project focuses on translating an advanced prediction and prognostics approach to fill the need for affordable and effective at-home solutions to treat sleep disorders. Sleep disorders such as obstructive sleep apnea (OSA) are prevalent in an estimated 6.6% of the national population. The market for sleep treatment is noted to exceed $23 billion per year, and is set to grow at over 15% annually. However the current treatment procedures suffer from severe drawbacks and are highly criticized in consumer forums. Recent advancements in sensors and wireless communication offer an unprecedented opportunity for cost-effective home care options to treat sleep apnea. This project will result in a prototype of SleepEaze technology that captures this opportunity. This technology is based on using a wireless biometric sleepwear to monitor the apnea patient''s biorhythms during sleep, and it employs a patent-pending algorithm to predict apnea events several minutes ahead of their onset. Then the muscles responsible for the obstruction can be stimulated when the event is predicted to be imminent ("nip in the bud"), allowing the patient a more restful sleep. The use of the innovative prediction algorithm as well as low power electronic elements offer a breakthrough in the noninvasive stimulations that can lead to a new class of affordable wearable devices for sleep apnea treatment with high commercialization potential. This project plans to pursue three major objectives: (a) Technology Improvement, which includes: the refinement of the wearable sensor layout to enhance comfort, tuning of parameters of the prediction model based on nonparametric Dirichlet Process Mixture of Gaussian Process representations to reduce computational overhead associated with multi-step look ahead procedures, and optimization of the stimulation modality, location, and time-frequency stimulation profiles using a novel low power electronics to effectively avert sleep apnea events; (b) Extended testing using an early prototype, extending an ongoing human subject study to benchmark signal quality, prediction and stimulation performance, and sleep quality improvement from the technology in preparation for approvals (510K) from the federal regulatory agencies; and (c) Prototyping of a updated wearable multi-sensor unit for real-time treatment of sleep apnea episodes, as well as its testing and benchmarking. If successful, the proposed project will result in a functional, refined prototype of the SleepEaze device (hardware and associated software interface) that offers a radically new approach for OSA treatment. In addition, personnel involved in this project, including a post-doctoral associate and two graduate students, will receive entrepreneurship experiences offered through Texas A&M University and the NSF Southwest I-Corps node.