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

Informazioni relative al progetto

SOMNIO

ID dell’accordo di sovvenzione: 960826

DOI

10.3030/960826

Progetto chiuso

Data della firma CE 7 Luglio 2020

Data di avvio 1 Novembre 2020

Data di completamento 30 Aprile 2023

Finanziato da

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Costo totale

€ 3 788 320,25

Contributo UE

€ 2 499 999,00

Coordinato da

ONERA BV
Netherlands

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

Periodo di rendicontazione: 2022-02-01 al 2023-04-30

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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