Sudden Unexpected Death in Epilepsy (SUDEP) is the leading cause of death in epilepsy children andotherwise healthy adult epilepsy patients, with a cumulative lifetime risk of ~8%. About 70% of SUDEP occursduring sleep, and nearly 90% are found in the prone (face-down) position. SUDEP can likely be prevented bythe simple intervention of repositioning and stimulating the patient after a convulsive seizure. Such interventionmust 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 criticalunmet medical need with an innovative smart mattress, the KORUS. Soterya has demonstrated feasibility bydeveloping a functional alpha prototype consisting of an array of expandable cells and a shapeable surfacethat safely and rapidly repositions human subjects. There are currently no products that detects the proneposition and physically repositions a patient into a recovery (sideways) position. The goal of this Phase I SBIRis to develop and validate two key technologies required to successfully develop a fully functional autonomousprototype: 1) advanced expandable cell with the size, weight, safety features, and noise management suitablefor a human clinical trial, while maintaining our benchmark of generating enough lift at a required velocity with a1000 lb/cell capacity; 2) embedded sensor system for rapid detection of body position change, and detection ofthe prone position. Soterya will optimize sensor manufacturing capabilities and software tools for bodypositioning visualization and data processing, and develop software for integrating these tools into a singlesensory network system. Human feasibility testing will be performed through our academic partners at theepilepsy and sleep medicine service of the Brigham and Women's Hospital. A total of 10 normative controlsubjects will be recruited to test the device efficacy in repositioning, awake testing to assess detection of bodyposition 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 30seconds; 2) detecting body position changes into a prone position with 95% accuracy. The completion of thisproject will position Soterya for the development of a fully functional prototype. A subsequent Phase 2 studywill pair the KORUS with a commercial seizure detection device for a clinical trial in the hospital epilepsymonitoring unit, with the ultimate goal of developing a fully embedded seizure detection and managementsystem. The development of KORUS as a medical device for the night-time management of convulsiveseizures will achieve a 50-75% risk reduction of night-time SUDEP.
Public Health Relevance Statement: Project Narrative Sudden Unexpected Death in Epilepsy (SUDEP) is the leading cause of death in young patients with epilepsy that typically occurs during sleep and in prone (face-down) position after a convulsion. The goal of this project is to develop the advanced expandable cell and sensor system that are key parts in developing a smart mattress. We expect an autonomous body repositioning smart mattress-KORUS will prevent the prone position after a seizure and significantly decrease the risk of night-time SUDEP by 50-75%.
Project Terms: Adult ; 21+ years old ; Adult Human ; adulthood ; Affect ; Aluminum ; Al element ; Arousal ; Asphyxia ; Suffocation ; asphyxiation ; Beds ; Cause of Death ; Cells ; Cell Body ; Child ; 0-11 years old ; Child Youth ; Children (0-21) ; youngster ; Clinical Trials ; Computers ; Convulsions ; Dangerousness ; Cessation of life ; Death ; Electroencephalography ; EEG ; Epilepsy ; Epileptic Seizures ; Epileptics ; Seizure Disorder ; epilepsia ; epileptiform ; epileptogenic ; Face ; faces ; facial ; Foundations ; Goals ; Hospitals ; Human ; Modern Man ; Mattresses ; Medical Device ; Medicine ; Mission ; Noise ; Patient Monitoring ; Patients ; Positron-Emission Tomography ; PET ; PET Scan ; PET imaging ; PETSCAN ; PETT ; Positron Emission Tomography Medical Imaging ; Positron Emission Tomography Scan ; Rad.-PET ; positron emission tomographic (PET) imaging ; positron emission tomographic imaging ; positron emitting tomography ; pressure ; Prone Position ; Respiration ; respiratory mechanism ; Risk ; Rubber ; Latex Rubber ; natural Rubber ; Safety ; Seizures ; Shark ; Sleep ; Computer software ; Software ; Software Tools ; Computer Software Tools ; Supervision ; Supination ; Technology ; Testing ; Thinness ; Leanness ; Time ; Weight ; Woman ; Custom ; Cell Size ; base ; density ; human subject ; sensor ; improved ; Surface ; Phase ; Medical ; Neurologic ; Neurological ; Time Management ; Lifting ; awake ; Neurologist ; Recovery ; Funding ; Shapes ; tool ; Life ; Sensory ; System ; Organ System ; body system ; Central Alveolar Hypoventilation ; Central Apnea ; Central Sleep Apnea Syndrome ; Central Sleep-Disordered Breathing ; Central Sleep-Disordered Breathings ; Ondine Syndrome ; Central Sleep Apnea ; Best Practice Analysis ; Benchmarking ; Services ; Performance ; novel ; Devices ; Position ; Positioning Attribute ; Convulsive Seizures ; Motor Seizures ; develop software ; developing computer software ; software development ; Intervention Strategies ; interventional strategy ; Intervention ; Risk Reduction ; data processing ; computerized data processing ; body position ; preventing ; prevent ; Address ; Advocate ; Data ; Detection ; Grant Proposals ; Applications Grants ; lifetime risk ; life-time risk ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Validation ; Monitor ; Development ; developmental ; post stroke ; after stroke ; poststroke ; cost ; rapid detection ; design ; designing ; manufacturing process ; innovation ; innovate ; innovative ; Impairment ; engineering design ; prototype ; commercialization ; flexibility ; flexible ; phase 2 study ; phase II study ; sudden unexpected death in epilepsy ; SUDEP ; recruit ; Visualization ; support vector machine ; feasibility testing ; Home ;
