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治疗完全向心性腭裂(CCCP)的解决方案，CCCP是阻塞性睡眠呼吸暂停(OSA)的一种严重的解剖表型。阻塞性睡眠呼吸暂停综合征影响全球超过10亿人，其中美国有5400万人。如果不进行治疗，CCCP会导致日间嗜睡、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，每年给美国医疗体系造成880亿美元的损失。值得注意的是，30%的OSA患者，即1600万美国人患有CCCP，这是一种治疗起来特别困难的睡眠呼吸暂停。超过一半的患者未能通过持续气道正压治疗(CPAP)的一线治疗，许多人避免了昂贵的手术，每年有600万人得不到治疗。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，主要针对CCCP和治疗不当的腭部塌陷。这项技术寻求通过提供具有重大社会和商业影响的可获得的治疗选项来改变睡眠呼吸暂停治疗。这一i-Corps项目基于神经刺激平台的开发，以满足阻塞性睡眠呼吸暂停(OSA)患者对非侵入性、临床有效的腭部塌陷治疗的需求。与适用性有限的传统神经刺激方法和侵入性植入不同，该方法采取了一种非侵入性的方法，通过靶向刺激腭部和咽部。该设备可以在诊所安装和滴定，并由患者每天晚上在家部署。这项技术涉及一种可拆卸的口腔矫治器，它在睡眠时激活刺激，为患者的灵感提供定时治疗。该装置包括口腔矫治器和无线充电盒，可以方便地控制刺激参数。该案例还记录并上传使用和疾病参数，为临床医生指导的治疗优化提供数据。通过包括台式、体外和体内猪和身体研究在内的研究验证，这项技术已准备好用于临床试验，并最终获得食品和药物管理局的批准。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，创造了解决阻塞性睡眠呼吸暂停综合征患者崩溃的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优势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.