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.

Grant Number: 5R44NS120394-03
NIH Institute/Center: NIH
Principal Investigator: Pranav Bansal