I-Corps: Neurostimulation Platform for Effective Treatment of Palatal Collapse in Obstructive Sleep Apnea

这个I-Corps项目的更广泛的影响/商业潜力是开发一种用于腭部完全同心塌陷（CCCp）的解决方案，这是阻塞性睡眠呼吸暂停（OSA）的严重解剖表型。OSA影响全球超过10亿人，其中美国有5400万人未经治疗，CCCP导致白天嗜睡，神经认知功能障碍，事故，并使心脏病发作，中风和糖尿病的风险增加一倍，每年花费美国医疗保健系统880亿美元。值得注意的是，30%的OSA患者，即1600万美国人，患有CCCp，这是一种特别具有挑战性的睡眠呼吸暂停治疗形式。超过一半的患者未能接受持续气道正压通气（CPAP）的一线治疗，许多人避免了昂贵的手术，每年有600万人未经治疗。该解决方案为OSA患者提供了一种非侵入性、临床有效的治疗方法，专注于CCCp和治疗效果不佳的腭部塌陷。该技术旨在通过提供具有重大社会和商业影响的可访问的治疗选择来改变睡眠呼吸暂停护理。该I-Corps项目基于神经刺激平台的开发，该平台解决了对阻塞性睡眠呼吸暂停（OSA）患者腭部塌陷的非侵入性临床有效治疗的需求。与适用性有限和侵入性植入的传统神经刺激方法不同，该方法采用非侵入性方法，将刺激靶向腭和咽。该装置可以在诊所内安装和滴定，并由患者每晚在家部署。该技术涉及一种可移动的口腔器具，可在睡眠期间激活刺激，定时治疗患者的吸气。包括口腔器具和无线充电盒的装置组使得能够容易地控制刺激参数。该病例还记录和上传使用情况和疾病参数，为临床医生指导的治疗优化提供数据。通过研究验证，包括实验室，体外和体内猪和尸体研究，已经准备好临床试验和最终的食品和药物管理局批准这项技术。这些研究证实了使用非侵入性神经刺激引起临床显著肌肉反应的能力，创造了解决OSA患者崩溃根本原因的解决方案。该奖项反映了NSF的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is the development of a solution for complete concentric collapse of the palate (CCCp), a severe anatomical phenotype of obstructive sleep apnea (OSA). OSA affects over 1 billion people globally, including 54 million in the U.S. Untreated, CCCp leads to debilitating daytime sleepiness, neurocognitive dysfunction, accidents, and doubles the risk of heart attack, stroke, and diabetes, costing the US healthcare system $88 billion annually. Notably, 30% of all OSA patients, or 16 million Americans, suffer from CCCp, a particularly challenging form of sleep apnea to treat. Over half of the patients fail the first-line treatment of continuous positive airway pressure (CPAP), and many avoid costly surgeries, leaving 6 million untreated yearly. This solution offers a non-invasive, clinically effective treatment for OSA patients, focusing on CCCp and poorly treated palatal collapse. This technology seeks to transform sleep apnea care by providing an accessible treatment option with significant societal and commercial impact.This I-Corps project is based on the development of a neurostimulation platform addressing the need for non-invasive, clinically effective treatment of palatal collapse in obstructive sleep apnea (OSA) patients. Unlike traditional neurostimulation methods with limited applicability and invasive implantation, this approach takes a non-invasive approach by targeting stimulation to the palate and pharynx. The device may be fit and titrated in-clinic and deployed by patients each night at-home. The technology involves a removable oral appliance that activates stimulation during sleep, timing therapy delivery to patient inspiration. The device set, comprising the oral appliance and a wireless charging case, enables easy control of stimulation parameters. The case also records and uploads usage and disease parameters, offering data for clinician-guided therapy optimization. Validation through research, including benchtop, ex-vivo and in-vivo porcine and cadaver studies, has poised this technology for clinical trials and eventual Food and Drug Administration approval. These studies confirm the ability to elicit clinically significant muscle responses using non-invasive neurostimulation, creating a solution that addresses the root cause of collapse in OSA patients.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.