Autonomous Sleep Care

Korus is a self-repositioning bed that provides autonomous repositioning. Its versatility makes it ideal for medical issues impacted by positioning, providing relief at home or in the hospital.

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Check out Autonomous Sleep Care on @MedStartr Today Korus is a self-repositioning bed that provides autonomous repositioning. Its versatility makes it ideal for medical issues impacted by positioning, providing relief at home or in the hospital. #MedMo #MedStartrVentures

https://www.medstartr.ai/s/UmerQwvdQ8Y

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Korus introduces a groundbreaking solution that addresses a critical challenge faced by hospitals and medical institutions worldwide: the need for constant, manual patient repositioning to prevent pressure injuries, enhance recovery, and ensure patient safety during sleep. Traditional patient care requires significant manpower for repositioning, especially at night, placing a strain on resources and increasing the risk of staff injuries from lifting and moving patients. Korus leverages advanced machine learning algorithms to autonomously adjust and reposition patients without human intervention, reducing the workload on healthcare staff and minimizing the risk of occupational injuries. This technology is particularly crucial for patients with conditions like epilepsy, where improper sleep positioning can lead to severe consequences, including SUDEP (Sudden Unexpected Death in Epilepsy). By autonomously moving patients from risky positions, Korus significantly enhances patient safety. Moreover, Korus's ability to adapt to various body types and positions ensures personalized care, improving sleep quality and aiding in faster recovery. Its implementation can lead to a reduction in pressure injuries—a common and costly problem in healthcare settings—by ensuring optimal pressure distribution throughout the night. For hospitals, integrating Korus means elevating the standard of care while optimizing operational efficiency. It allows medical institutions to allocate their resources more effectively, focusing on critical care and other essential tasks. Additionally, by reducing the incidence of pressure injuries, hospitals can lower the costs associated with prolonged hospital stays and treatments, directly impacting their bottom line positively. In essence, Korus presents a win-win solution for medical institutions: enhancing patient safety and comfort while significantly reducing the physical and financial strains on the healthcare system. Its adoption marks a step forward into a future where technology and healthcare merge to offer smarter, safer, and more efficient patient care.

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Clinical Validation

Korus shows promising benefits for several medical issues. However, our primary goal is to develop a night-time seizure management system to lower the risk of sudden unexpected death in epilepsy (SUDEP). Here is the basis of our research. Convulsive seizures during sleep and prone position are a major risk factor for SUDEP. About 70% of SUDEP occurs after a nocturnal generalized tonic-clonic seizure (GTCS)1–3 due to greater cardiorespiratory instability during sleep, postictal airway obstruction, and increased likelihood of being alone.4 Up to 87.6% of patients are found in the prone (face-down) position after a nocturnal SUDEP1,5, even though the incidence of post-convulsive prone position is low (4.2-7.2%).6,7 Central apnea3,8,9 and autonomic instability10–12 have been identified as key risk factors for SUDEP. Prone sleeping position blunts arousal responses and reduces heart rate variability, potentially contributing to both.13–15 The relative risk of SUDEP in the prone vs non-prone position following a GTCS is over 60-fold.16 SUDEP can be prevented by repositioning and stimulating the patient. Patients can be saved from SUDEP by repositioning to avoid the postictal prone position: 1) Sudden Infant Death Syndrome (SIDS), the closest analogous disorder to SUDEP sharing many pathophysiologic features17–19 and similar risk with prone position20,21; has been reduced by up to 75% through “back to sleep” prevention campaigns.20,22–24 2) Every SUDEP documented by video-EEG has died in the prone position.3,25–27,16-18 Asphyxia from airway obstruction and hypoventilation due to the patient’s prone positioning has been documented on video-EEG.25 3) At home, merely having nocturnal supervision or a bed partner decreases the risk of SUDEP28–31, suggesting that simple interventions such as repositioning and stimulating the patient substantially decrease risk.   The timing of intervention is critical. In convulsions leading to SUDEP, terminal asystole and apnea occur as soon as 25 sec postictally and in virtually everyone by 180 sec3. Intervention must occur during this time. One patient died of SUDEP wearing a seizure detection device (considered best in class) that was functioning flawlessly; he was found prone in bed despite help arriving in 15 minutes.32 Autonomous intervention is therefore imperative. There are currently no methods to deliver interventions within the required period. Korus has a first-in-class potential to intervene to prevent SUDEP autonomously. Korus will continually monitor patients during sleep, detect the post-convulsion prone position, and reposition/stimulate patients to the optimal recovery (sideways) position. It will provide precision monitoring and autonomous intervention. This overcomes the critical challenge that most patients with SUDEP are found unattended, and many patients do not have bedroom-level supervision. Korus was developed after careful examination of multiple potential solutions, including wearable vests, smart belts, and other designs. The final design was chosen with a patient focus group organized by the Epilepsy Foundation of New England. Main References 1. Ali, A. et al. Association of sleep with sudden unexpected death in epilepsy. Epilepsy & Behavior 76, 1–6 (2017). 2. Lamberts, R. J., Thijs, R. D., Laffan, A., Langan, Y. & Sander, J. W. Sudden unexpected death in epilepsy: people with nocturnal seizures may be at highest risk. Epilepsia 53, 253–257 (2012). 3. Ryvlin, P. et al. Incidence and mechanisms of cardiorespiratory arrests in epilepsy monitoring units (MORTEMUS): a retrospective study. Lancet Neurol 12, 966–977 (2013). 4. Alexandre, V. et al. Risk factors of postictal generalized EEG suppression in generalized convulsive seizures. Neurology 85, 1598–1603 (2015). 5. Liebenthal, J. A., Wu, S., Rose, S., Ebersole, J. S. & Tao, J. X. Association of prone position with sudden unexpected death in epilepsy. Neurology 84, 703–709 (2015). 6. Wang, S. et al. The incidence of peri-ictal prone position in patients with generalized convulsive seizures. Epilepsy and Behavior 61, 158–161 (2016). 7. Shmuely, S., Surges, R., Sander, J. W. & Thijs, R. D. Prone sleeping and SUDEP risk: The dynamics of body positions in nonfatal convulsive seizures. Epilepsy Behav 62, 176–9 (2016). 8. Vilella, L. et al. Postconvulsive central apnea as a biomarker for sudden unexpected death in epilepsy (SUDEP). Neurology 92, e171–e182 (2019). 9. Vilella, L. et al. Association of Peri-ictal Brainstem Posturing With Seizure Severity and Breathing Compromise in Patients With Generalized Convulsive Seizures. Neurology 96, e352–e365 (2021). 10. Myers, K. A. et al. Heart rate variability in epilepsy: A potential biomarker of sudden unexpected death in epilepsy risk. Epilepsia 59, 1372–1380 (2018). 11. Nayak, C. S., Sinha, S., Nagappa, M., Thennarasu, K. & Taly, A. B. Lack of heart rate variability during sleep-related apnea in patients with temporal lobe epilepsy (TLE)—an indirect marker of SUDEP? Sleep and Breathing 21, 163–172 (2017). 12. Thijs, R. D., Ryvlin, P. & Surges, R. Autonomic manifestations of epilepsy: emerging pathways to sudden death? Nat Rev Neurol 17, 774–788 (2021). 13. Galland, B., Reeves, G., Taylor, B. & Bolton, D. Sleep position, autonomic function, and arousal. Arch Dis Child Fetal Neonatal Ed 78, F189–F194 (1998). 14. Kato, I. et al. Spontaneous Arousability in Prone and Supine Position in Healthy Infants. Sleep 29, 785–790 (2006). 15. Richardson, H. L., Walker, A. M. & Horne, R. S. C. Sleep position alters arousal processes maximally at the high-risk age for sudden infant death syndrome. Journal of Sleep Research 17, 450–457 (2008). 16. Esmaeili, B., Dworetzky, B. A., Glynn, R. J. & Lee, J. W. The probability of sudden unexpected death in epilepsy given postictal prone position. Epilepsy Behav 116, 107775 (2021). 17. Sowers, L. P., Massey, C. A., Gehlbach, B. K., Granner, M. A. & Richerson, G. B. Sudden unexpected death in epilepsy: fatal post-ictal respiratory and arousal mechanisms. Respir Physiol Neurobiol 189, 315–23 (2013). 18. Massey, C. A., Sowers, L. P., Dlouhy, B. J. & Richerson, G. B. Mechanisms of sudden unexpected death in epilepsy: the pathway to prevention. Nature Reviews Neurology 10, 271–282 (2014). 19. Richerson, G. B. & Buchanan, G. F. The serotonin axis: Shared mechanisms in seizures, depression, and SUDEP. Epilepsia 52, 28–38 (2011). 20. Guntheroth, W. G. & Spiers, P. S. Sleeping prone and the risk of sudden infant death syndrome. JAMA 267, 2359–62 (1992). 21. Ponsonby, A. L., Dwyer, T., Gibbons, L. E., Cochrane, J. A. & Wang, Y. G. Factors potentiating the risk of sudden infant death syndrome associated with the prone position. N Engl J Med 329, 377–82 (1993). 22. Gemble, A. et al. Knowledge assessment of sudden infant death syndrome risk factors in expectant mothers: A prospective monocentric descriptive study. Arch Pediatr 27, 33–38 (2020). 23. Changing concepts of sudden infant death syndrome: implications for infant sleeping environment and sleep position. American Academy of Pediatrics. Task Force on Infant Sleep Position and Sudden Infant Death Syndrome. Pediatrics 105, 650–6 (2000). 24. Mitchell, E. A., Brunt, J. M. & Everard, C. Reduction in mortality from sudden infant death syndrome in New Zealand: 1986-92. Arch Dis Child 70, 291–4 (1994). 25. Tao, J. X. et al. SUDEP, suspected positional airway obstruction, and hypoventilation in postictal coma. Epilepsia 51, 2344–2347 (2010). 26. McLean, B. N. & Wimalaratna, S. Sudden death in epilepsy recorded in ambulatory EEG. J Neurol Neurosurg Psychiatry 78, 1395–1397 (2007). 27. SJ, P., M, W.-Y. & VP, S. Sudden death in epilepsy: single case report with video-EEG documentation. Epilepsia 33, 123 (1992). 28. Langan, Y., Nashef, L. & Sander, J. W. Case-control study of SUDEP. Neurology 64, 1131–1133 (2005). 29. Nashef, L., Fish, D. R., Garner, S., Sander, J. W. A. S. & Shorvon, S. D. Sudden Death in Epilepsy: A Study of Incidence in a Young Cohort with Epilepsy and Learning Difficulty. Epilepsia 36, 1187–1194 (1995). 30. van Andel, J., Thijs, R. D., de Weerd, A., Arends, J. & Leijten, F. Non-EEG based ambulatory seizure detection designed for home use: What is available and how will it influence epilepsy care? Epilepsy and Behavior 57, 82–89 (2016). 31. Sveinsson, O., Andersson, T., Mattsson, P., Carlsson, S. & Tomson, T. Clinical risk factors in SUDEP: A nationwide population-based case-control study. Neurology (2019) doi:10.1212/WNL.0000000000008741. 32. Picard, R. W. et al. Wrist sensor reveals sympathetic hyperactivity and hypoventilation before probable SUDEP. Neurology 10.1212/WNL.0000000000004208 (2017) doi:10.1212/WNL.0000000000004208. 33. Rheims, S. & Ryvlin, P. Patients’ safety in the epilepsy monitoring unit: time for revising practices. Curr Opin Neurol 27, 213–8 (2014). 34. Sauro, K. M., Wiebe, S., Macrodimitris, S., Jette, N. & Team, E. M. U. Q. I. Quality indicators for the adult epilepsy monitoring unit. Epilepsia 57, 1771–1778 (2016). 35. Sauro, K. M. et al. Quality and safety in adult epilepsy monitoring units: A systematic review and meta-analysis. Epilepsia 57, 1754–1770 (2016).

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