Replacing sleep labs: The first clinical grade home-based diagnostic of sleep disorders

Project Information

SOMNIO

Grant agreement ID: 960826

DOI

10.3030/960826

Project closed

EC signature date 7 July 2020

Start date 1 November 2020

End date 30 April 2023

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 788 320,25

EU contribution

€ 2 499 999,00

Coordinated by

ONERA BV
Netherlands

Periodic Reporting for period 2 - SOMNIO (Replacing sleep labs: The first clinical grade home-based diagnostic of sleep disorders)

Reporting period: 2022-02-01 to 2023-04-30

Summary of the context and overall objectives of the project

Onera is the next generation of medical grade sleep diagnostics and monitoring. Alarmingly, 80% of people who suffer from a sleep disorder remain undiagnosed due to the high costs, time and specialized resources required by current clinical solutions. In recent years, innovations have focused on developing simple screening devices such as smart watches or mattress sensors that provide limited and inaccurate information about sleep quality. Onera is set to change this, by redefining the ‘gold standard’ with our proprietary diagnostic solution. Onera’s clinical-grade wearable consists of adhesive patches as simple and non-intrusive as applying a band-aid, with maximum wearing comfort. The technology is valuable for remote respiratory monitoring to reduce burden on the healthcare system following the COVID-19 pandemic. Commercializing such innovative wireless sensors and machine learning algorithms is made possible by Onera’s team leveraging >10 years of experience at IMEC, a world-leading research institute in nanoelectronics and digital technologies. Our solution is designed for use at home. Our vision is to transform sleep medicine by redefining sleep diagnostics as a service. Capitalizing on the major market hype for sleep trackers and push from healthcare payors to move to home diagnoses, Onera is disrupting the field with a new service model that replaces overnight in-lab studies and allows for user-friendly, cost-effective, and scalable sleep diagnostics globally.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Onera’s patch-based polysomnography (PSG) device, under the commercial name Onera STS, is cleared for market access for both the European market as well as for the US market. As part of the process of obtaining regulatory clearance as a medical device, the safety and effectiveness of the device has been demonstrated by (external) compliance testing as well as (clinical) validation studies. Onera continues to carry on clinical studies and commercial pilots to generate additional economic and clinical evidence, driving further clinical adoption of its unique self-applied home PSG technology. The company launched in 2022 its end-to-end solution for clinical-grade home sleep studies, Onera PSG-as-a-Service, in EU and US. In the meantime, the company has set up its first customers and commercial pilots in both geographies, as well as several strategic partnerships

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Onera’s easy-to-use and clinical-grade device and software platform in combination with its PSG-as-a-Service business model will enable reach to a group of undiagnosed patients that would otherwise never arrive in the diagnostic pathway for sleep disorders. Onera will make gold-standard diagnostics possible wherever the patient is, also at home, overcoming the current limitations in healthcare systems regarding scarcity of medical facilities and access to qualified personnel.

Onera STS