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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.

项目总结/摘要癫痫猝死（SUDEP）是癫痫儿童死亡的主要原因，其他健康成人癫痫患者，累积终生风险约为8%。大约70%的SUDEP发生在在睡眠中，近90%的人处于俯卧位（面朝下）。SUDEP可能通过以下方式预防：在惊厥发作后对患者进行复位和刺激的简单干预。这种干预必须在惊厥后的关键3分钟窗口内快速自主地进行。索特里亚，股份有限公司、以开发技术降低SUDEP风险为使命，这是一个创新的智能床垫，KORUS。Soterya已经证明了可行性，开发一个功能性的阿尔法原型，它由一系列可扩展的细胞和一个可成形的表面组成，能安全快速地重新定位人体目前还没有产品可以检测到位置并将患者物理地重新定位到恢复（侧向）位置。第一阶段SBIR的目标是是开发和验证成功开发一个功能齐全的自动驾驶汽车所需的两项关键技术，原型：1）先进的可扩展细胞的大小，重量，安全功能，和噪音管理适合对于人体临床试验，同时保持我们的基准，即以所需的速度产生足够的升力， 1000磅/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，并检测俯卧位Soterya将优化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单一的感觉网络系统人类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医学服务。共10项规范控制将招募受试者来测试设备在重新定位、清醒测试中的功效，以评估身体检测位置变化，以及用于检测睡眠期间自发的身体位置变化的夜间测试。本研究的关键是：1）在30分钟内将受试者从俯卧位安全复位至恢复位秒; 2）以95%的准确度检测身体位置变化为俯卧位。完成这一该项目将定位Soterya开发一个功能齐全的原型。随后的II期研究将KORUS与商业癫痫发作检测设备配对，用于医院癫痫临床试验监测单位，最终目标是开发一个完全嵌入式的缉获检测和管理系统，系统KORUS作为夜间惊厥管理医疗器械的开发癫痫发作将使夜间SUDEP的风险降低50 - 75%。