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

I-Corps：有效治疗阻塞性睡眠呼吸暂停中腭塌陷的神经刺激平台

• 批准号: 2346870
• 负责人: Youseph Yazdi
• 金额: $ 5万
• 依托单位: Johns Hopkins University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-02-15 至 2025-01-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2346870&HistoricalAwards=false
• 关键词: Corps; Neurostimulation; Platform; Effective; Treatment

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.

该I-Corps项目的更广泛的影响/商业潜力是开发触觉完全同心崩溃（CCCP）的解决方案，这是一种严重的阻塞性睡眠呼吸暂停（OSA）的严重解剖表型。 OSA影响全球超过10亿人口，其中包括美国未经治疗的5400万人，CCCP导致白天昏昏欲睡，神经认知功能障碍，事故发生，并使心脏病发作，中风和糖尿病的风险增加一倍，使美国医疗保健系统每年造成880亿美元。值得注意的是，所有OSA患者中有30％或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形式。一半以上的患者未能通过一线持续气道压力（CPAP）治疗，许多患者避免了昂贵的手术，每年剩下600万次未经治疗的手术。该解决方案为OSA患者提供了非侵入性，临床上有效的治疗方法，重点是CCCP和治疗不佳的palatal崩溃。这项技术试图通过提供具有重大社会和商业影响的可访问治疗方案来改变睡眠呼吸暂停护理。这项I-Corps项目基于开发神经刺激平台的发展，该计划满足了在阻塞性睡眠APNEA（OSA）患者中对非侵入性，临床上有效治疗的临床有效治疗的需求。与传统的神经刺激方法不同，适用性有限和侵入性植入方法，这种方法通过将刺激靶向口感和咽部来采用非侵入性方法。该设备可能会适合并滴定在临床上，并每天晚上由患者在家中部署。该技术涉及一种可移动的口服设备，可在睡眠期间激活刺激，定时治疗将患者的灵感传递给患者。该设备设置包括口服设备和无线充电盒，可轻松控制刺激参数。该病例还记录并上传了使用和疾病参数，为临床医生引导的治疗优化提供了数据。通过研究的验证，包括台式，前体内和体内猪和尸体研究，已为这项技术提供了临床试验和最终食品和药物管理局批准的批准。这些研究证实了使用非侵入性神经刺激引起临床上重要的肌肉反应的能力，创造了一种解决方案，以解决OSA患者崩溃的根本原因。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的知识分子和更广泛影响的审查标准通过评估来通过评估来支持的。