SBIR Phase I: Non-invasive Closed Loop Neuromodulation to Treat Obstructive Sleep Apnea

SBIR 第一阶段：无创闭环神经调节治疗阻塞性睡眠呼吸暂停

• 批准号: 2304265
• 负责人: Desmond Keenan
• 金额: $ 26.99万
• 依托单位: NEUROSOMNICSLLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2304265&HistoricalAwards=false
• 关键词: SBIR; Phase; Non; invasive; Closed

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a non-invasive, externally worn appliance for treating obstructive sleep apnea (OSA), a condition affecting over 88 million Americans (26% of the American adult population). Those impacted by OSA are at risk of serious comorbidities such as diabetes, stroke, and heart disease. Many sufferers remain untreated due to intolerance to current treatment options with adherence and compliance rates as low as 40%. The economic impact is estimated at $30 billion resulting in $150 billion aggregate indirect costs due to motor and workplace accidents as well as productivity losses each year. The technology aims to capture part of the $18 billion sleep device market which remains significantly under penetrated due to approximately 80 million undiagnosed cases in the US alone. This Small Business Innovation Research (SBIR) Phase I project aims to develop a non-invasive, dental neurostimulation device capable of activating the motor nerve fibers supplying the muscles responsible for dilating the upper airway in a controlled, non-perceptible manner. The appliance will be integrated with multiple sensing and stimulation electrodes to activate precise nerve branches in order to provide continuous innervation of relevant upper airway muscle groups, without interfacing directly with the nerve branch itself. Algorithms employing machine learning will be used to process neural electrode feedback signals and control electrical field stimulation waveforms. The project will consist of appliance design, benchtop testing, and overnight sleep studies in patients to build datasets and construct new algorithms. A software application will then be developed to automate routines in real-time in order to demonstrate concept feasibility of a new non-invasive therapy for obstructive sleep apnea.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.

这项小型企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力是一种无创，外部磨损的用于治疗阻塞性睡眠呼吸暂停（OSA）的设备，这种情况影响了超过8800万美国人（美国成年人的26％人口）。 受OSA影响的人有严重合并症，例如糖尿病，中风和心脏病。由于对当前治疗方案的不耐受性和依从性低至40％，许多患者仍未受到治疗。经济影响估计为300亿美元，由于汽车和工作场所事故以及每年的生产力损失，造成1500亿美元的间接成本。 该技术旨在捕捉一部分耗资180亿美元的睡眠设备市场，该市场仅在美国就大约8000万个未诊断的病例而被渗透了。这项小型企业创新研究（SBIR）I期项目旨在开发一种无创，牙科神经刺激装置，能够激活运动神经纤维，以提供负责以受控的，不可感染的方式扩张上层气道的肌肉。该设备将与多种感应和刺激电极集成，以激活精确的神经分支，以提供相关上呼吸道肌肉群的连续支配，而无需直接与神经分支本身接口。使用机器学习的算法将用于处理神经电极反馈信号和控制电场刺激波形。该项目将包括设备设计，台式测试和患者的过夜睡眠研究，以构建数据集并构建新算法。然后，将开发软件应用程序实时自动化例程，以证明新的非侵入性疗法用于阻塞性睡眠呼吸暂停的概念可行性。该奖项反映了NSF的法定任务，并被认为通过使用基金会的评估来表现出值得的支持。智力优点和更广泛的影响审查标准。