Reliable Medical Grade Home-Based Test for Self-Use for people with Sleep DIsorders

Informazioni relative al progetto

S-trodes

ID dell’accordo di sovvenzione: 190162340

DOI

10.3030/190162340

Progetto chiuso

Data della firma CE 20 Novembre 2023

Data di avvio 1 Novembre 2023

Data di completamento 31 Gennaio 2026

Finanziato da

• The European Innovation Council (EIC)

Costo totale

€ 3 672 500,00

Contributo UE

€ 2 457 113,75

Coordinato da

X-TRODES LTD
Israel

Periodic Reporting for period 1 - S-trodes (Reliable Medical Grade Home-Based Test for Self-Use for people with Sleep DIsorders)

Periodo di rendicontazione: 2023-11-01 al 2024-10-31

Sintesi del contesto e degli obiettivi generali del progetto

Sleep disorders are prevalent in one third of the global population, across various age groups, and considered a public health epidemic. Nevertheless, sleep disorders are often unrecognized and under-reported. These disorders can contribute to other medical problems, and some may also be symptoms for underlying mental health issues.
Sleep monitoring is essential for reliable diagnosis and improved management of sleep disorders. Currently, sleep disorders are only measured during an overnight Polysomnography (PSG); however, this method is limited in clinical implication due its unavailability, high cost, unnatural sleep environment and episodic brain patterns. The X-trodes Sleep System (S-trodes), with its Smart Skin technology, will enable monitoring treatment efficacy: replacing conventional PSG with home-based accessible technology.

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

• X -trodes updated the design of the X-trodes main components, with focus on the Data Aquistion Unit (DAU aka XTR Recording Device) and the Smart Skin Dry electrodes, to optimize their suitability for Sleep tests.
A first batch of the new components, including new Smart Skin patches has been produced and went through verification tests, successfully. These devices will be utilized during the planned clinical validation.
• X-trodes developed algorithms for detection of REM Sleep Without Atonia (RWSA), and Spindles in EEG signals during Sleep tests.
• X-trodes have made significant progress with developing Auto-Scoring algorithms, and we expect to complete and verify the development during 2025.
• In addition, X-trodes moved to a new Cloud platform (Bio-T) to optimize our Web App functionality and usability, in the future, this Cloud platform may facilitate the ability to provide Sleep Report generation and Patient Management to Sleep Health providers.

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)

• Clinical Data collection and Preliminary laboratory tests have been performed, and the X-trodes Sleep System passed the tests successfully, indicating a possibility to perform the CE submission ahead of time.
• X-trodes developed Data Quality assessment algorithms, that are used to assess the quality of recorded data during a Sleep Test. This Data Quality report is used to troubleshoot and further improve X-trodes electrophysiological signal aquisition technology.
• We have performed studies and published peer reviewed articles on the subject of Sleep monitoring and analysis in a natural setting (See dissemination activities section, items about RWSA and Sleep Spindles)
• X-trodes has secured the endorsement of lead KOLs and advisors in the European Sleep Medicine society:
→ Prof. Dr. Thomas Penzel (President, German Sleep Society), (President-Elect, World Sleep Society), (Director of Interdisciplinary Sleep Medicine Centre, Charité University Hospital, Germany), (Chair of the Sleep Medicine Committee of the ESRS
→ Prof. Dr. Dieter Riemann (JOURNAL OF SLEEP RESEARCH EDITOR), (EUROPEAN INSOMNIA NETWORK (EIN) CHAIR)

Updated XTR Recording device design

Updated XTR Recording device with Sleep Electrodes Patch (Facial EXG7)