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（SUDEP）突然意外死亡是癫痫儿童死亡的主要原因，否则健康的成人癫痫患者，累计终身风险约为8％。大约70％的SUDEP发生在睡眠期间，在俯卧（面向下）位置发现了近90％。 Sudep可能会被抽搐癫痫发作后，简单的重新定位和刺激患者的干预措施。这种干预抽搐后必须在关键的3分钟窗口内快速自主执行。 Soterya， Inc.由开发技术以降低SUDEP的风险的使命建立，它解决了这一关键创新的智能床垫Korus未满足医疗需求。 Soterya证明了开发功能性α原型这种安全，快速重新定位人类受试者。目前没有任何产品可检测到易于的位置并物理重新定位患者恢复（侧面）位置。这个阶段的目标是开发和验证成功开发出功能齐全的自主性所需的两种关键技术原型：1）具有大小，重量，安全功能和噪声管理的高级可扩展单元进行人类临床试验，同时保持我们以所需速度产生足够升力的基准 1000磅/细胞容量； 2）嵌入式传感器系统快速检测身体位置变化，并检测俯卧的位置。 Soterya将优化传感器制造功能和人体软件工具定位可视化和数据处理，并开发用于将这些工具集成到单个的软件感觉网络系统。人类的可行性测试将通过我们的学术伙伴在杨百翰和妇女医院的癫痫和睡眠医学服务。总共10个正常对照将招募受试者以测试重新定位的设备效率，清醒测试以评估身体的检测位置变化，并在睡眠过程中检测自发的身体位置变化的隔夜测试。这项研究的里程碑将为1）安全地将受试者从容易发生的恢复位置中放置在30中秒2）检测身体位置的精度为95％。完成此完成项目将定位Soterya以开发功能齐全的原型。随后的2期研究将Korus与商业癫痫发作设备配对，以便在医院癫痫病中进行临床试验监视单元，其最终目标是开发完全嵌入的癫痫发作检测和管理系统。 Korus作为抽搐夜间管理的医疗设备的发展癫痫发作将使夜间Sudep的风险降低50-75％。