Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - NEUROON-MED (NEUROON-MED – the future of at-home diagnosis of sleep disorders)

Teaser

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...

Summary

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.

Work performed

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.
We have developed all individual modules of our innovative system that have been successfully tested and prepared for implementation in the final device:
a. Additional EOG channel - we built bioelectric amplifier for the acquisition of EOG signal.
b. Mask with replaceable airflow sensor - we have added the new air flow sensor port, new type of nasal tubes and chosen the best flow sensors for measurement conditions – specific for our system..
c. Wireless chest belts - We have successfully developed electronic module for the chest belts which contains MCU with wireless communication function, analog frontend and IMU sensor.

The quality of the signal acquired by our sensors and transmission stability is like in other competitive expensive medical devices.
d. Cloud Deployment- automatic sleep scoring using clinically tested AI algorithms is delivered as a cloud service.
e. Desktop application - multi-platform (supporting Windows, MacOs and Linux) native desktop application was developed as a part of Neuroon-Med system.

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. The first step is to realize a pilot production of 100 pieces with 98% efficiency, i.e. a production reject of no more than 2%.
We have also begun preparations of the clinical study which protocol and 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 study start-up has begun with fulfilling all regulatory and insurance requirements. It was a necessary to obtain the permissions from the hospital intern ethics committees in Poland (Bioethics Committee). Inteliclinic successfully has obtained all permissions that are necessary to start the main study on the volounteers. Typically, the bioethical commission grants permission for research limited to one year. In our case, the bioethics commission considered the project to be extremely innovative and forward-looking, giving us permission to study for a longer period - up to 3 years. FDA regulations has been addressed. The insurance of participant is also covered. The model framework contract for research, which will be implemented at the Institute, has been successfully defined. Patients and volunteers recruitment/exclusion criteria, confidentially agreements, consent forms, and participant remuneration have been set. These Tasks has been carried out by designated personnel at the responsible hospital (Psychiatry and Neurology Institute) with cooperation with the Inteliclinic.
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.
conducted with several specialists and engineers in

Final results

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 +90% 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.

Website & more info

More info: https://neuroonopen.com/.