A Device to Prevent Night-time Sudden Unexpected Death in Epilepsy

Background: Sudden Unexpected Death in Epilepsy (SUDEP) is the leading cause of death in epilepsy children and otherwise healthy adult epilepsy patients. 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. There are currently no products that detect the prone position or have the ability to physically reposition a patient into a recovery position. Methods: We address this critical unmet medical need with a smart mattress, the Korus, consisting of an array of inflatable cells. We developed 1) a sensor system to rapidly detect body change with high accuracy; 2) an advanced expandable cell that is capable of generating the required lift at sufficient velocity to reposition a patient from the prone to the recovery (sideways) position. Results: Each inflatable cell that comprises the Korus has the capacity to generate lift to 1000 lb/cell at a rate of 2 inches per second. The embedded sensor array can detect body position change within 5 seconds. A total of 10 normative control subjects were tested. Repositioning from a prone to recovery (sideways) position while manually controlling the cells was successful in 100% of attempts with an average time of 21.75 sec. Body position detection resulted in an accuracy in detecting the prone position of 96.8% and an overall accuracy of detecting the correct body position (supine, prone, left, right) of 92.4%. In long-term studies including sleep, Korus detected the correct position during 97.3% of the time during the recording. False body position change rate was 2.3 events/hour. There were no incorrect position detections when subjects switched into the prone position. Discussion: This study demonstrates the feasibility of developing a smart mattress to detect the prone position and rapidly repositioning subjects into a recovery position. Future development include the development of a control system to automate repositioning based on sensor data. The completion of this device, when paired with a seizure detection device, has the potential to lower the risk of SUDEP by >50%. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement NIH R43NS120394 ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Ethics committee/IRB of the Mass General Brigham gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors