Wearable electroencephalogram band development and integration with a customizable therapeutic software for monitoring and remote treatment of sleep disorders and complaints

• Grant number: 22/13130-9
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Duration: February 01, 2023 - April 30, 2025
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Renata Redondo Bonaldi
• Grantee: Renata Redondo Bonaldi
• Host 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
• Pesquisadores principais: Mariana Cardoso Melo
• Associated researchers: Bruna Roberta Alves da Silva ; Gabriel Natan de Souza Pires ; Julia Ribeiro da Silva Vallim ; Ksdy Maiara Moura Sousa Werli
• Associated research grant: 20/00666-2 - Association of wearable motion sensor and electroencephalogram for sleep staging: validation and development of algorithm, AP.PIPE
• Associated grant(s): 24/14501-6 - FAPESP Week Italy 2024, AR.EXT; 23/07160-5 - Commercial development of sleep monitoring with portable electroencephalogram in pilot clients, AP.PIPE
• Associated scholarship(s): 23/05091-6 - Development of the basis of the solution based on Artificial Intelligence and Machine Learning (Challenge 1), BP.TT; 23/01682-0 - Solution Architecture, Database Modeling and Prototype Development (Challenge 1), BP.TT; 23/00706-2 - Development of algorithms and predictive models for the personalization of therapeutic resources and their communication with the wearable EEG band (Challenge 1), BP.TT

Abstract

Sleep disorders encompass a wide spectrum of diseases with significant consequences for individual health and high economic costs for society. Sleep disorders intensified after the COVID-19 pandemic, reaching about 40% of the world population, and represent a problem both for individuals and society, as they are associated with a higher incidence of non-communicable chronic diseases, resulting in higher expenses with the health system and increased morbidity and mortality. Treatment for insomnia includes pharmacological and non-pharmacological approaches, used together or alone. Cognitive Behavioral Therapy for Insomnia (CBT-I) is an approach that provides guidance to patients so that they are able to recognize and modify patterns of behavior and thought, which may be triggers or events that perpetuate the symptoms of insomnia. The effectiveness of CBT-I is high and comparable to pharmacological interventions, being recognized and consolidated as the gold standard of treatment; digital CBT-Ii (dCBT-I) has emerged as an alternative, of equivalent effectiveness, with a better cost/benefit ratio than conventional CBT-I, leading to significant savings and return on investment, mainly by reducing presenteeism and absenteeism. In this context, given that the causes of insomnia are multifactorial, with highly heterogeneous clinical conditions and hardly ever fully addressed by the solutions found on the market, SleepUp, with FAPESP support, has been developing and improving an integrated, customizable and remote solution, clinically validated and approved by ANVISA, for prevention and management of insomnia and other sleep disorders, based on dCBT-I. In this Indirect PIPE Phase 2 submission, SleepUp proposes the development of a proprietary wearable EEG device for sleep monitoring, and the related software, responsible for its customizable operation, and integration with the treatment already offered by SleepUp. This project deliverables will be: (i) sleep staging algorithm validated from data captured by wearable EEG devices; (ii) integration of the sleep staging algorithm with the SleepUp proprietary wearable EEG device and "SleepUp" already existent application; and (iii) development of customizable combined use methodology with sleep staging algorithm, SleepUp proprietary wearable EEG device, and SleepUp application software. The SleepUp therapeutic program is composed of techniques adapted to a self-instructional digital application format. Additional features include mindfulness therapy, meditation techniques, and tips on sleep and quality of life. The major expected outcomes are the increase in total sleep time and improvement of habits and behaviors, with a direct impact on the quality of life, cognition, attention, memory and mood, for clients; pharmaceuticalcompanies will be able to know, monitor and clinically evaluate the effectiveness of new drugs; health operators will be able to expand the offer of benefits, with cost reduction in relation to equivalent treatments. Additionally, the expansion of SleepUp's scope will provide the democratization of access, with increased adherence to the treatment of a costly disorder that impairs the individual's intellectual, social and/or professional performance and whose spontaneous remission is rare. (AU)