Miniaturized plasma emission spectroscopy-based breath analysis for unobtrusive at-home monitoring and prediction of COPD exacerbations

Project Information

BREATH-SENSE

Grant agreement ID: 101115028

DOI

10.3030/101115028

EC signature date 14 August 2023

Start date 1 November 2023

End date 30 April 2027

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 505 325,00

EU contribution

€ 3 505 325,00

Coordinated by

ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands

Periodic Reporting for period 2 - BREATH-SENSE (Miniaturized plasma emission spectroscopy-based breath analysis for unobtrusive at-home monitoring and prediction of COPD exacerbations)

Reporting period: 2024-11-01 to 2025-10-31

Summary of the context and overall objectives of the project

Patients diagnosed with from Chronic Obstructive Pulmonary disease (COPD) suffer from persistent airway obstruction, causing shortness of breath and extreme fatigue. Patients are repeatedly hospitalised due to acute flare-ups known as exacerbations, which are largely responsible for the morbidity and mortality associated with COPD. Exacerbations are diagnosed based on symptoms only, and diagnosis is often too late. There is an urgent need for a reliable technology for unobtrusive, continuous at-home monitoring of COPD patients to enable timely prediction and treatment of exacerbations.

The Breath-Sense consortium aims to develop the first-ever hand-held breathalyser for non-invasive detection of breath biomarkers for COPD exacerbations. RespiQ has developed a breakthrough breath analysis technology and will collaborate with experts and specialists in sensor development (SINTEF), advanced electrical engineering (uRoboptics), user experience and co-creation (NeLL/LUMC), and clinical COPD management (KCL). The consortium will combine innovative technological advancements with human-centric user-experience research to develop and validate a transformative clinical workflow, ultimately aiming for at-home monitoring of COPD patients. With this digital biomarker-based monitoring solution, patients and clinicians will benefit from reliable, timely prediction of exacerbations, leading to early treatment and preventing up to 95% hospitalisations. The Breath-Sense workflow will deliver a paradigm shift in COPD management, from symptom-based, delayed diagnosis to preventive monitoring before symptom worsening. The Breath-Sense technology has the potential to improve the health of millions of people.

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

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.

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)

The Breath-Sense project has made great progress beyond existing technologies in two critical areas: miniaturized plasma emission spectroscopy and research into COPD management landscape.
In RP1, the development of a plasma-generating microchip marked a milestone in miniaturising plasma emission spectroscopy, a technology offering sensitivity and specificity comparable to lab equipment like GC-MS with a much smaller footprint, lower cost, and a user-friendly interface. Unlike electrochemical technologies, Breath-Sense offers specific and accurate measurements of the chemical composition. This technology has the potential to benefit other gas analysis applications (e.g. environmental monitoring, industrial processes). A key RP1 accomplishment is the comprehensive study of the COPD management landscape, which involves stakeholder mapping and a contextual analysis of healthcare systems. This research provided a deep understanding of the patient journey, current intervention strategies, and the needs of stakeholders. The study also identified barriers and enablers of the adoption of new monitoring technologies, offering valuable insights for integrating our technology in the COPD management workflow.
In RP2 the project has progressed beyond early laboratory concepts by significantly advancing both technical feasibility and automated data interpretation, both of which are essential for real-world use. Early results strongly suggest that the technology can reliably identify clinically relevant breath biomarkers, addressing a key limitation of existing portable breath analysis solutions. To ensure further uptake and impact, the next steps include clinical validation with patient samples, continued regulatory alignment, and refinement of both device and clinical workflow based on user feedback. Preparation for future exploitation is well underway.