The Breath-Sense project has made significant progress in developing an innovative breath analyser while exploring user needs and engaging stakeholders to shape the COPD workflow.
Reporting Period 1
The most notable achievement was the successful development of a functional plasma-generating microchip, developed using planar technology. Technical specifications for the supporting system were established, and a working prototype has been developed to provide a suitable plasma ignition condition and a controlled environment for testing, validation and further optimisation of the future generation microchips. Early stakeholder engagement (patients, clinicians, healthcare professionals) identified challenges and barriers to using the Breath-Sense device in real-world settings. This feedback is useful to improve the device design and its integration into existing COPD management workflows, ensuring the device is effective, user-friendly, and easy to incorporate into daily routines. The team made progress in understanding the regulatory requirements for future clinical use. Ethical considerations have been integrated into the project, particularly regarding the clinical use and the AI components of our device. An ethics plan has been developed to ensure that the Breath-Sense machine learning algorithms are transparent and fair, with a focus on protecting patient data. Moreover, the clinical trial plan includes measures to ensure patient safety, informed consent, and confidentiality, in accordance with relevant ethical standards and regulations.
Reporting Period 2
During the second reporting period, the Breath-Sense project made substantial progress toward a practical, clinically relevant breath analysis device. Key advances were achieved in further developing and improving the core microplasma chip, resulting in improved stability and longer operating times under realistic (near-atmospheric) conditions. These improvements support a more compact design and advance the project closer to a device suitable for clinical use with COPD patients. In parallel, extensive engagement with patients and healthcare professionals helped translate user needs into clear requirements for the device, mobile application, and care workflow. The COPD care pathway was mapped to ensure smooth integration of Breath-Sense into existing clinical practice. Preparations for future clinical use have continued, leading to significant advancements in ethical and regulatory planning, while early data analysis has shown promising results in identifying relevant breath biomarkers. Together, these activities strengthen the foundation for validation and clinical feasibility studies in the next phase.
