The Internet of Things assists in the diagnosis and monitoring of sleep apnea30 de outubro de 2018
By Suzel Tunes | FAPESP Research for Innovation – Tácito Mistrorigo de Almeida, a Brazilian electronic engineer, sought assistance from pulmonologist Geraldo Lorenzi Filho, who specializes in sleep medicine, with a need and a plan: developing a treatment for apnea (temporarily shallow or blocked breathing during sleep) and bringing to market a new technology to monitor this chronic disease remotely. “I used to be annoyed by having to submit to a polysomnogram or sleep study, the traditional test used to monitor sleep apnea,” Almeida recalls. “You spend a night in hospital with several electrodes stuck to your body. It’s expensive and uncomfortable. Plus it’s hard to get an appointment, and you have to wait in line.”
Lorenzi, who heads the Sleep Laboratory at the Heart Institute (INCOR) of Hospital das Clínicas, the teaching hospital attached to the University of São Paulo’s Medical School (HC-FMUSP), treated the patient and agreed to help develop a sleep apnea monitoring system. From this partnership was born the healthtech startup Biologix, founded in 2015 in São Paulo City.
The system, which is ready to be commercialized, consists of a portable sensor that records patient data while the patient is asleep at home and sends the data to a cloud-based platform, generating a report that can be accessed using a smartphone app by both patient and doctor.
The app itself is called Biologix; the wireless sensor is Oxistar. Both were developed by the startup. “We issued our first invoices last September,” says Almeida, who has a contract with a chain of laboratories to offer the test as part of its client checkup list.
“Our business model is based on selling the service, not the product,” Almeida explains. For this reason, in addition to doctor offices and laboratories, Biologix believes that corporate personnel departments are also potential customers, as the test can be considered prevention against absenteeism and workplace accidents due to sleep disorders.
In August 2018, Biologix won support from the PIPE/PAPPE Grant Program, which combines funding from FAPESP’s Innovative Research in Small Business Program (PIPE) and the Program to Support Research in the Private Sector (PAPPE) run by FINEP, the federal government’s innovation agency, to promote the marketing of innovative products. “This support has been fundamental,” Almeida says. “For example, it’s enabled us to hire a sales manager.”
Sick people without a diagnosis
According to a study published in 2010 in the journal Sleep Medicine by researchers at the Federal University of São Paulo (UNIFESP), three in ten adults suffer from obstructive sleep apnea syndrome (OSAS), a progressive chronic disorder characterized by the reduction or momentary cessation of airflow, oxygen desaturation and fragmented sleep. The respiratory effort and deficient oxygenation involved can lead to cardiovascular problems, increasing the risk of heart attack and stroke, for example.
OSAS is treatable, but research has shown that it is underdiagnosed. Some 90% of people with sleep apnea are estimated to be unaware of their condition. Popularizing its diagnosis by means of a simpler and more affordable procedure is the goal pursued by Biologix. According to Almeida, a polysomnogram can cost more than 2,500 Brazilian reals (now approximately 640 US dollars). The test developed by Biologix costs 10%-15% as much as a polysomnogram and can be conducted for two nights to confirm the diagnosis.
The test is based on an analysis of the patient’s blood oxygen levels while sleeping. “In an apnea episode, the upper airways are blocked, preventing the passage of air and reducing oxygenation of the bloodstream. Biologix uses a pulse oximeter to detect the number and frequency of drops in oxygenation per hour,” Almeida explains.
The device includes a light sensor that is attached to a finger and detects changes in blood color as the level of oxygen-saturated hemoglobin rises or falls. “A 3% drop in blood oxygenation is enough to diagnose sleep apnea,” he says. “In the most severe cases, oxygenation may fall by 25%. This happens several times per night.”
The pulse oximeter, he notes, is a noninvasive way to measure oxygen saturation and is widely used in hospitals, where it is connected by wires to a bedside monitor. The wireless Oxistar sensor transmits data via Bluetooth to the Biologix app installed in the patient’s smartphone. The device also contains an actimetry sensor to detect whether the patient is awake or asleep with approximately 80% accuracy based on motor activity.
According to Almeida, the Biologix system is innovative both in Brazil and worldwide. “There are some portable oximeters on the market, but they aren’t suitable for continuous use and don’t have the response time or resolution required for this test,” he says.
Validation at INCOR
Oxistar has been approved by ANVISA, the national health surveillance agency, and ANATEL, the telecommunications regulator (required because the device transmits data via Bluetooth). It has also undergone a process of validation at INCOR, which compared the results of 332 polysomnograms with those of Biologix. “To date we’ve analyzed data from 219 patients, showing 91% sensitivity and 83% specificity for Biologix in diagnosing moderate to severe sleep apnea,” Almeida says.
These scientific findings on the system were presented in May 2018 to an international conference of the American Thoracic Society held in San Diego, California (USA). In October, the healthtech startup was one of 27 firms preselected for evaluation in the second stage of FINEP Startup. The federal agency’s innovative startup support program will invest approximately R$1 million in each finalist. While awaiting announcement of the winners, Almeida continues to look for commercial partners and is making plans to enhance the platform. “We’re developing a new feature to record patients snoring on their smartphone,” he says. “The system will use machine learning technology to identify the sound, which will contribute to the diagnosis. This new functionality should be ready in early 2019.”