Desenvolvimento comercial do monitoramento do sono com eletroencefalograma portatil com clientes pilotos

• Grant number: 24/07759-7
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: October 01, 2024
• End date: September 30, 2025
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Paula Villena Redondo
• Grantee: Paula Villena Redondo
• 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
• Associated researchers: Iraciana de Lima Nobre Adriano ; Ksdy Maiara Moura Sousa Werli
• 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 targeting sleep disorders such as insomnia and sleep apnea. Insomnia has a high prevalence in Brazil, with about 35% of the population showing symptoms of chronic insomnia, which is associated with decreased quality of life, higher rates of absenteeism, increased morbidity and comorbidities, as well as higher healthcare costs and usage. Despite being a debilitating clinical condition, the treatments offered for insomnia are scarce and often ineffective, such as medication use. On the other hand, sleep apnea affects one in three people and is characterized by airway obstruction during sleep, causing sleep fragmentation and consequently impacting quality of life, being related to chronic diseases such as obesity, hypertension, and diabetes.Sleep disorders are detected through an exam called polysomnography, the gold standard technique for sleep evaluation. However, despite its high sensitivity and specificity, polysomnography is a costly and complex exam, and its application is still limited to specialized clinics and a few states in Brazil. According to data from SUS (Unified Health System), only around two exams per municipality are performed annually in Brazil, with few states offering it, and waiting lists extending to years. Therefore, the incidence of sleep disorders is 45% of the population, and current treatments and diagnoses are neither accessible nor effective.This has led to an increased demand for wearable devices capable of conducting monitoring and examinations with clinical validation, as well as seeking effective treatments for insomnia and sleep apnea. Despite the high demand for sleep monitoring technology, its safety and efficacy are a concern: many lack validation studies, comparison with gold standard methods, and/or certification by regulatory entities.Based on this, SleepUp developed a solution for sleep monitoring and insomnia treatment based on portable electroencephalogram (EEG) associated with other sensors. The applicability of the developed solution is broad, assisting in home monitoring, treatment, and diagnosis of sleep disorders remotely, digitally, effectively, and accessibly, thus meeting a significant market need. During PIPE Phase 1, held 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 company developed a methodology and wearable technology for sleep staging, including an EEG headband and other sensors, and its integration with the "SleepUp" app. Part of the commercial strategy was covered by the 2023 SEBRAE supplement call.The proponent has already obtained technical and scientific validation of the proprietary algorithm and presented its results at dozens of national and international conferences, as well as winning awards, such as first place in the global Santander prize focused on the Internet of Things and Artificial Intelligence, among 300 startups, and the national acceleration program by Flextronic in partnership with FIT, Softex, and MCTI. Thus, with the advancements achieved through PIPE 2 and SEBRAE 2023, the proponent now seeks, with this 2024 SEBRAE call, to bring the complete EEG solution to the market, performing clinical application validation in a real environment, by using the solution in patients under treatment or suspected of sleep disorders. (AU)