Telehealth for the Diagnosis and Treatment of Obstructive Sleep Apnea in the Brazilian Public Health System (SUS).

• Grant number: 23/10264-7
• Support Opportunities: Research Grants - Research in Public Policies
• Start date: June 01, 2024
• End date: May 31, 2028
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Luciano Ferreira Drager
• Grantee: Luciano Ferreira Drager
• Host Institution: Instituto do Coração Professor Euryclides de Jesus Zerbini (INCOR). Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• Associated researchers: Carlos Roberto Ribeiro de Carvalho ; Evelinda Marramon Trindade ; Geraldo Lorenzi Filho ; Pedro Rodrigues Genta ; Sonia Dias Lanza Freire

Abstract

Context: The aging of the Brazilian population poses new challenges for public health policies. Non-communicable chronic diseases (NCDs) accounted for 54.7% of deaths in Brazil in 2019. Cardiovascular and respiratory diseases are among the leading causes of mortality. Obstructive sleep apnea (OSA) affects about 33% of the adult population. OSA is the most common respiratory disease and severe OSA contributes to increased cardiovascular mortality . However, the majority of patients with suspected OSA lack access to diagnostic methods or treatment within the public health system (SUS). OSA treatment ranges from simple measures such as avoiding sleeping on the back, nasal decongestion, weight loss, and oropharyngeal exercises to more specialized approaches such as surgeries, mandibular advancement devices, and continuous positive airway pressure (CPAP). Treating severe OSA with CPAP has been associated with improved daytime sleepiness, quality of life, and reduced cardiovascular risk. Due to the lack of a public policy addressing OSA diagnosis and treatment, the State of São Paulo has witnessed multiple legal actions. In 2019, in partnership with the São Paulo State Health Secretariat, we conducted a mass diagnostic study of 1,013 patients with suspected OSA using home-based polysomnography. In the same study, we validated the Biologix polysomnography system in a sample of 413 patients. Biologix is a national startup supported by FAPESP (3 PIPEs Phase III) capable of diagnosing OSA at home through a low-cost system with cloud-based automatic analysis. Hypotheses: Our three main hypotheses are: 1) The majority of patients diagnosed with OSA in the 2019 mass screening remain without proper guidance or treatment. 2) Telemedicine utilization will enable the implementation of a cost-effective program for the diagnosis and guidance of patients with mild to moderate OSA, as well as the treatment and monitoring of severe OSA cases with CPAP. 3) The results from Phases 1 and 2 will lay the groundwork for a sustainable program for the diagnosis and treatment of OSA. Methods: Phase 1: We will conduct structured telemedicine interviews with patients diagnosed with OSA in the 2019 mass screening (n=806). We estimate successful contact with 50% of the sample. Patients with severe OSA who remain without proper guidance or treatment will be referred to Phase 2. Phase 2: We will conduct teleconsultations with patients from Phase 1 (nE 120) and also patients from the CROSS system waiting list for polysomnography in DRS 1 (Greater São Paulo), totaling 1,600 patients. All patients will undergo teleconsultations, telemedicine appointments, and home-based Biologix polysomnography. Patients with mild to moderate OSA will receive standardized guidance via teleconsultation. Patients with severe OSA will be referred for CPAP adaptation and monitoring through telemonitoring (nE 330). Patients will be randomized to receive either automatic CPAP or fixed pressure CPAP. Patients in the fixed pressure group will start with CPAP= 8 cmH2O, and the pressure will increase by 2 cmH2O increments guided by online CPAP data. This experimental design will address a secondary hypothesis that fixed-pressure CPAP results in similar adherence to automatic CPAP. The primary objective of Phase 2 will be to provide objective data on the cost required for the diagnosis and effective treatment of severe OSA patients with CPAP. Phase 3: Phase 3 will occur throughout the entire study. Systematic meetings with public administrators overseeing the project will be conducted to aim for the incorporation of a telemedicine-based OSA diagnosis and treatment protocol by CONITEC. (AU)