Commercial development of sleep monitoring with portable electroencephalogram in pilot clients

• Grant number: 23/07160-5
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: September 01, 2023
• End date: August 31, 2024
• Field of knowledge: Health Sciences - Medicine
• Agreement: SEBRAE-SP
• Principal Investigator: Thábita Carneiro Maganete
• Grantee: Thábita Carneiro Maganete
• Company: SleepUp Tecnologia em Saúde Ltda
• CNAE: Desenvolvimento e licenciamento de programas de computador não-customizáveis ; Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• City: São Caetano do Sul
• Associated researchers: Ksdy Maiara Moura Sousa Werli ; Nuccia Cardinale Diniz Castro
• Associated research grant: 22/13130-9 - Wearable electroencephalogram band development and integration with a customizable therapeutic software for monitoring and remote treatment of sleep disorders and complaints, AP.PIPE

Abstract

SleepUp is a digital platform aimed at sleep disorders such as insomnia and sleep apnea. Insomnia has been a highly prevalent sleep disorder in Brazil, about 35% of the population has symptoms of chronic insomnia, which is associated with a worsening of quality of life, higher rates of absenteeism, increased morbidities and comorbidities, as well as increased costs and use of health services. However, despite Insomnia being a debilitating clinical condition, the treatments offered are scarce and often ineffective, as in the case of medication. On the other hand, sleep apnea affects one in three people, is characterized by an obstruction in the airways during sleep, causing sleep fragmentation and consequent impact on quality of life, being related to chronic diseases such as obesity, hypertension and diabetes. Sleep disorders are detected through an exam called polysomnography, this is the gold standard technique for sleep assessment, however, despite its high sensitivity and specificity, polysomnography is a costly, highly complex exam, and its application is still limited to specialized clinics and a few states in Brazil. According to data from the SUS (Sistema Único de Saúde), only around 2 tests are performed per municipality per year in Brazil, few states offer them, and the waiting lists reach years. Therefore, the incidence of sleep disorders is 45% of the population, and current treatments and diagnoses are not accessible and effective. Therefore, the search for wearable devices capable of monitoring and examining with clinical validation has increased, as well as the search for effective treatments for insomnia and sleep apnea. Despite the high demand for sleep monitoring technology, its safety and effectiveness are cause for concern: many lack validation studies, comparison with gold standard methods and/or certification by regulatory bodies. Based on this, SleepUp developed a sleep monitoring and insomnia treatment solution, based on a portable electroencephalogram associated with other sensors. The applicability of the developed solution is wide and can assist in home monitoring, treatment and diagnosis of sleep disorders, in a remote, digital, effective and accessible way, thus solving a great market need. During PIPE Phase 1, which took place in 2021, the proponent developed the technical-scientific proof of concept for the use of wearable technologies for sleep monitoring, quantification and staging. In PIPE Phase 2, the objective is to develop a methodology and wearable technology for sleep staging, including an electroencephalogram track and other sensors, and its integration with the "SleepUp" application. Part of these PIPE 2 objectives have already been achieved. The proponent has already obtained technical and scientific validation of the proprietary algorithm and has already presented its results in dozens of national and international congresses, as well as winning awards, mentioning the first place in the innovation award of the Fleury group. In this way, with the progress obtained by PIPE 2, the proponent now seeks to insert the solution in the market, carrying out the validation of the clinical application in a real environment, through the use of the solution in patients under treatment or suspected of sleep disorders. (AU)