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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.

项目概要/摘要癫痫猝死（SUDEP）是癫痫儿童和癫痫患者死亡的主要原因其他方面健康的成年癫痫患者，终生累积风险约为 8%。大约 70% 的 SUDEP 发生睡眠时，近 90% 的人处于俯卧（面朝下）姿势。 SUDEP 可以通过以下方式预防：惊厥性癫痫发作后重新定位和刺激患者的简单干预措施。这样的干预必须在抽搐后关键的 3 分钟时间内快速、自主地进行。索特里亚, Inc. 的成立宗旨是开发降低 SUDEP 风险的技术，解决这一关键问题创新型智能床垫 KORUS 未满足的医疗需求。 Soterya 已通过以下方式证明了可行性开发由一系列可扩展单元和可塑形表面组成的功能性阿尔法原型安全、快速地重新定位人类受试者。目前还没有产品能够检测到易感人群定位并将患者重新定位到恢复（侧向）位置。第一阶段 SBIR 的目标是开发和验证成功开发功能齐全的自主驾驶所需的两项关键技术原型：1) 先进的可扩展电池，其尺寸、重量、安全特性和噪音管理均适合对于人体临床试验，同时保持我们以所需速度产生足够升力的基准 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将优化车身传感器制造能力和软件工具定位可视化和数据处理，并开发将这些工具集成到一个单一的软件中感觉网络系统。人体可行性测试将通过我们的学术合作伙伴进行布莱根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，以及夜间测试以检测睡眠期间自发的身体位置变化。这项研究的里程碑将是 1) 在 30 天内将受试者从俯卧位置安全地重新定位到恢复位置秒； 2) 检测身体姿势变为俯卧位，准确率达 95%。本次的完成该项目将使 Soterya 能够开发功能齐全的原型。随后的第二阶段研究将 KORUS 与商用癫痫检测设备配对，用于医院癫痫症临床试验监测单元，最终目标是开发完全嵌入式癫痫检测和管理系统。 KORUS 作为夜间治疗惊厥的医疗设备的开发夜间 SUDEP 的癫痫发作风险可降低 50-75%。