A Device to Prevent Sudden Unexpected Death in Epilepsy (SUDEP)

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 simple interventions such as turning and stimulating. Such intervention must be performed quickly within a 3- minute window prior to death. Soterya, Inc. was founded with the mission to develop technologies to decrease the risk of SUDEP. We plan to address this critical unmet medical need with significant market potential with a smart mattress, the Korus. There are currently no products that detect the prone position or have the ability to physically reposition a patient into a recovery position. In the Phase I SBIR, we developed an advanced prototype with advanced expandable cells generating necessary lift with a 1000 lb/cell capacity and an embedded sensor system that rapidly detects body change with an accuracy of >95% for detecting the prone position. Aim 1 this Phase II SBIR is to construct enhanced hardware and develop software for completely autonomous repositioning a patient from the prone to recovery (sideways) position. An advanced bed environment simulation with a “Digital Twin” mirroring patient action will be created. Using this environment, a biomechanical framework focusing on 16 key anatomical landmarks for body articulation and machine learning will be utilized to develop optimal strategies for repositioning. This data will be utilized by a control system that will activate the appropriate smart cells for surface reshaping. Normative control subjects (10 total) will be recruited for overnight studies to assess the accuracy in determining body position within 5 seconds, and autonomously repositioning from the prone to a recovery position within 30 seconds. Aim 2 of this study is to assess body positioning recognition utilizing the Korus sheet sensor system in patients after generalized tonic- clonic seizures. Testing will be performed through our academic partners at the Brigham and Women’s Hospital epilepsy service. Epilepsy patients (50 total) admitted to the Epilepsy Monitoring Unit will be recruited to assess the accuracy of the Korus sensing system in detecting body position changes in both the ictal and postictal phases. The completion of this project will position Soterya for the development of a fully functional device that will be utilized in a clinical trial to autonomously and safely prevent prone positioning of patients with epilepsy.