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A device to prevent Sudden Unexpected Death in Epilepsy (SUDEP)

预防癫痫猝死（SUDEP）的装置

基本信息

批准号：
10323597
负责人：
Jong Woo Lee
金额：
$ 50.26万
依托单位：
SOTERYA, INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-21 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10323597
关键词：
Address Adult Advocate Affect Aluminum Applications Grants Arousal Asphyxia Beds Benchmarking Cause of Death Cell Size Cells Central Sleep Apnea Cessation of life Child Clinical Trials Computer software Computers Convulsions Custom Dangerousness Data Detection Development Devices Electroencephalography Epilepsy Face Foundations Funding Goals Home Hospitals Human Impairment Intervention Life Lifting Mattresses Medical Medical Device Medicine Mission Monitor Motor Seizures Neurologic Neurologist Noise Patient Monitoring Patients Performance Phase Positioning Attribute Positron-Emission Tomography Prone Position Recovery Respiration Risk Risk Reduction Rubber Safety Seizures Sensory Services Shapes Shark Sleep Small Business Innovation Research Grant Software Tools Supervision Supination Surface System Technology Testing Thinness Time Time Management Validation Visualization Weight Woman awake base body position body system commercialization computerized data processing cost density design engineering design feasibility testing flexibility human subject improved innovation lifetime risk manufacturing process novel phase 2 study post stroke pressure prevent prototype rapid detection recruit sensor software development sudden unexpected death in epilepsy support vector machine tool

项目摘要

Project Summary/Abstract Sudden Unexpected Death in Epilepsy (SUDEP) is the leading cause of death in epilepsy children and otherwise healthy adult epilepsy patients, with a cumulative lifetime risk of ~8%. About 70% of SUDEP occurs during sleep, and nearly 90% are found in the prone (face-down) position. SUDEP can likely be prevented by the simple intervention of repositioning and stimulating the patient after a convulsive seizure. Such intervention must be performed quickly and autonomously within a critical 3-minute window after a convulsion. Soterya, Inc., founded with the mission to develop technologies to decrease the risk of SUDEP, addresses this critical unmet medical need with an innovative smart mattress, the KORUS. Soterya has demonstrated feasibility by developing a functional alpha prototype consisting of an array of expandable cells and a shapeable surface that safely and rapidly repositions human subjects. There are currently no products that detects the prone position and physically repositions a patient into a recovery (sideways) position. The goal of this Phase I SBIR is to develop and validate two key technologies required to successfully develop a fully functional autonomous prototype: 1) advanced expandable cell with the size, weight, safety features, and noise management suitable for a human clinical trial, while maintaining our benchmark of generating enough lift at a required velocity with a 1000 lb/cell capacity; 2) embedded sensor system for rapid detection of body position change, and detection of the prone position. Soterya will optimize sensor manufacturing capabilities and software tools for body positioning visualization and data processing, and develop software for integrating these tools into a single sensory network system. Human feasibility testing will be performed through our academic partners at the epilepsy and sleep medicine service of the Brigham and Women’s Hospital. A total of 10 normative control subjects will be recruited to test the device efficacy in repositioning, awake testing to assess detection of body position changes, and overnight testing for detecting spontaneous body position changes during sleep. Milestones for this study will be 1) safely repositioning subjects from a prone to a recovery position within 30 seconds; 2) detecting body position changes into a prone position with 95% accuracy. The completion of this project will position Soterya for the development of a fully functional prototype. A subsequent Phase 2 study will pair the KORUS with a commercial seizure detection device for a clinical trial in the hospital epilepsy monitoring unit, with the ultimate goal of developing a fully embedded seizure detection and management system. The development of KORUS as a medical device for the night-time management of convulsive seizures will achieve a 50-75% risk reduction of night-time SUDEP.

项目摘要/摘要癫痫猝死(SUDEP)是癫痫儿童和儿童死亡的主要原因其他健康的成年癫痫患者，具有累积终生风险~8%。大约70%的SUDEP发生在在睡眠中，近90%的人处于俯卧(脸朝下)姿势。SUDEP很可能可以通过以下方式防止抽搐发作后对病人进行重新定位和刺激的简单干预。这样的干预抽搐后，必须在关键的3分钟时间内迅速自主地实施。索特里亚， Inc.成立的使命是开发降低SUDEP风险的技术，解决这一关键问题利用创新的智能床垫KORUS，满足未得到满足的医疗需求。Soterya已经通过以下方式证明了可行性开发由可扩展单元格阵列和可成形表面组成的功能阿尔法原型安全而快速地重新定位人类受试者。目前还没有检测到俯卧位的产品定位和身体上将病人重新定位到恢复(侧身)的位置。这一阶段SBIR的目标是是开发和验证成功开发全功能自动驾驶所需的两项关键技术原型：1)先进的可扩展电池，尺寸、重量、安全特性和噪音管理适合对于人体临床试验，同时保持我们的基准，以所需的速度产生足够的升力 1000磅/个电池容量；2)嵌入式传感器系统，用于快速检测身体位置变化，并检测俯卧姿势。Soterya将优化车身的传感器制造能力和软件工具定位可视化和数据处理，并开发软件将这些工具集成到一个感觉网络系统。人体可行性测试将通过我们的学术合作伙伴在布里格姆妇女医院的癫痫和睡眠药物服务。共有10个规范性对照受试者将被招募来测试设备的重新定位效果，清醒测试来评估对身体的检测体位变化，以及检测睡眠期间自发体位变化的通宵测试。这项研究的里程碑将是1)在30分钟内将受试者从俯卧位安全地重新定位到恢复体位秒；2)检测身体位置变化为俯卧位，准确率为95%。这项工程的完成该项目将为Soterya开发全功能原型奠定基础。随后的第二阶段研究将KORUS与商业癫痫检测设备配对，在癫痫医院进行临床试验监测股，最终目标是开发一个完全嵌入癫痫检测和管理系统系统。KORUS作为夜间惊厥治疗医疗设备的发展癫痫发作将使夜间SUDEP的风险降低50%-75%。