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NEUROON-MED – the future of at-home diagnosis of sleep disorders

Periodic Reporting for period 3 - NEUROON-MED (NEUROON-MED – the future of at-home diagnosis of sleep disorders)

Reporting period: 2019-06-01 to 2020-05-31

More than 100 million people suffer from sleep apnea (SA) worldwide according to the WHO data. People with SA have a life expectancy 20 years shorter than the average life span. Additionally, they have a three- to sevenfold increased risk of motor vehicle crashes. The economic impact of sleep disorders is massive, specialists from the Harvard School of medicine calculated that costs of SA only in the US accounts for $115 billion every year. The main problem the world is facing with stopping the SA epidemic is not a treatment but diagnosis. It is estimated that 85% of people who suffer from SA have never been diagnosed. The reason for the low screening rate of SA is a limited access to polysomnography (PSG) – the gold standard for testing sleep disorders.
At Inteliclinic, we have developed the NeuroOn-MED mask which is addressing the customers need for effective and inexpensive solution for home diagnosis of SA. Our advantage over competitors is built upon the technological excellence of NeuroOn-MED, which analyses the brainwaves and eye movements in the same way as PSG does. The sensors of NeuroOn-MED (EEG, EOG, pulse oximetry, and others) combined with artificial intelligence algorithms for sleep data analysis provide +90% of PSG effectiveness, allowing for distinguishing between sleep stages and various variants of SA. Comparing with the currently offered home sleep monitors which are capable only of diagnosing moderate and severe SA cases.
The product design was improved based on inputs on the external setup, functionality, manufacturability, and performance in order to bring the design to a level that the product will function and look as commercial product. Components were tested for functionality, mechanically and in the usability aspect. In the communication process, we successfully examined its two most important indicators, which are: time and the percentage of lost signal frames. As the greatest value provided by the Neuroon-MED system is the biological data collected during sleep from the patient at home - it is absolutely crucial that the data loss in the transmission process has to be minimal.
We have developed all individual modules of our innovative system that have been successfully tested and prepared for implementation in the final device. As our system consists of several devices, we have implemented a global time synchronization, thanks to which all collected data does not have time stamps shifted. Synchronization is performed by the docking station wirelessly at a fixed time interval. We have implemented a special module for estimating the energy consumption planned for the upcoming test to avoid the situation of discharge of the device during the test and data loss.
Based on long research on every aspect of physiological measurements at home and constant contact with doctors, we developed a complete system prototype that meets the latest telemedicine standards. A device was created, whose dimensions are the smallest on the market, which was refined not only in technical terms, but also in terms of ergonomics.
An optimal production process has been developed from scratch to ensure successful production. We have realized a pilot production of 100 devices with 98% efficiency and a production reject of no more than 2%.
We have analyzed the currently applicable certification standards and prepared the required documentation and samples for testing.
The design of our final device have received a positive opinion from the Bioethics Committee of the Institute of Psychiatry and Neurology in Warsaw, Poland.
The clinical study model of our system has been successfully defined. Patients and volunteers recruitment/exclusion criteria, confidentially agreements, consent forms, and participant remuneration have been set. The purpose of the clinical study was to compare the automatically scored NeuroOn-MED results (nRDI) to the manually scored polysomnography RDI (PSG-RDI). The NeuroOn and polysomnography data have been recorded simultaneously in a time-synchronization manner. Our research shows that the effectiveness of the automatic sleep analysis performed by our system is 76.36% and is comparable to the effectiveness of the assessment made by a doctor, which on average is 76.90%
In the commercialization and communication field, comprehensive market analysis and communication plan have been prepared. The plans details the strategy to communicate the development and launch of the product to ensure success of NeuroOn – MED mask and to publicize the funding received by the EU Horizon 2020 grant. As part of those activities, we attended several conferences dedicated to the problem of sleep disorders and reached broad audience using social media, mainly Facebook, our you tube channel, company’s website, video content, promotional materials. Meetings were conducted with several specialists and engineers in order to create a user community and a partner ecosystem. In the course of talks and meetings as well as in-depth market research, we were able to define our client segments better and choose the optimal way of communication for them.
A patent application has been filed that will provide protection at a general level - describing the entire Neuroon-MED system and an application providing protection at a detailed level - the most innovative part of the system, the respiratory analysis module with EOG measurement and wireless communication.
Our product provides completely new quality to the segment of home diagnostic devices for sleep apnea. We offer the highest accuracy of SA detection supported by the highest comfort of usage. Our advantage over competitors is built upon the technological excellence of NeuroOn sleep mask, which automatically analyses brainwaves using EEG. The sensors of NeuroOn sleep mask combined with improvements of NeuroOn-MED – EOG sensors, nasal tube for airflow measurement, andchest belts for screening the respiratory effort – will provide best apnea diagnosis precision.
Our mask does not have bunches of electrodes attached individually to the body as the competitive solutions. The electrodes in the mask are really low resistance and can be used without gel, which make the whole examination more comfortable and less problematic. Additionally, we are offering powerful cloud for remote processing of sleep data (SaaS model) using advanced algorithms based on neural networks.
The highest accuracy of NeuroOn-MED is provided by monitoring of brainwaves, respiratory flow and pneumatic effort. Powerful cloud computing enables real time processing of sleep data using AI algorithms based on neural networks. All sensors of NeuroOn- MED are wireless therefore patient do not need to struggle with bunches of cables.
The ultimate goal of the NeuroOn-MED project is to fully commercialise the innovative medical device for home diagnosis of sleep apnea.