Periodic Reporting for period 1 - BREATH-SENSE (Miniaturized plasma emission spectroscopy-based breath analysis for unobtrusive at-home monitoring and prediction of COPD exacerbations)
Reporting period: 2023-11-01 to 2024-10-31
Patients suffering from Chronic Obstructive Pulmonary disease (COPD) suffer from persistent airway obstruction causing shortness of breath and extreme fatigue. Patients are repeatedly hospitalized 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 and continuous at-home monitoring of COPD patients to enable timely exacerbation prediction and treatment.
The Breath-Sense consortium aims to develop the first-ever hand-held breathalyzer for non-invasive detection of breath biomarkers. RespiQ has developed a breakthrough breath analysis technology, and will collaborate with sensor development expert SINTEF, user-experience and co-creation expert NeLL and clinical COPD specialist KCL. The consortium will combine innovative technological advancements with human-centric user-experience research to develop and validate a transformative clinical workflow for at-home monitoring of COPD patients. With this digital biomarker-based monitoring solution, patients and clinicians will benefit from reliable and timely prediction of exacerbations, leading to early treatment intervention and preventing up to 95% hospitalizations. The Breath-Sense workflow will deliver a paradigm shift in COPD management, from symptom-based delayed diagnosis towards preventative at-home monitoring prior to symptom worsening. The Breath-Sense technology has the potential to improve the health of millions of people.
The Breath-Sense consortium aims to develop the first-ever hand-held breathalyzer for non-invasive detection of breath biomarkers. RespiQ has developed a breakthrough breath analysis technology, and will collaborate with sensor development expert SINTEF, user-experience and co-creation expert NeLL and clinical COPD specialist KCL. The consortium will combine innovative technological advancements with human-centric user-experience research to develop and validate a transformative clinical workflow for at-home monitoring of COPD patients. With this digital biomarker-based monitoring solution, patients and clinicians will benefit from reliable and timely prediction of exacerbations, leading to early treatment intervention and preventing up to 95% hospitalizations. The Breath-Sense workflow will deliver a paradigm shift in COPD management, from symptom-based delayed diagnosis towards preventative at-home monitoring prior to symptom worsening. The Breath-Sense technology has the potential to improve the health of millions of people.
BreathSense project has made significant progress in developing an innovative breath analyzer while exploring user needs, and engaging stakeholders to shape the COPD workflow.
The most notable achievement was the successful development of a functional plasma-generating microchip, a core component of the BreathSense device. The microchip, developed using planar technology is the first step to enabling mass production of a breath analysis device for the management of COPD, ensuring that it can be offered at an attractive price point for the end user. The ability to generate plasma at a microscopic scale has been demonstrated, marking an essential step forward in the project. Supporting this major milestone, technical specifications for the supporting system were established, while a working prototype is being developed to provide a suitable plasma ignition condition and a controlled environment for precise testing, validation and further optimization of the future generation microchips. Although further refinements are still required, the initial results in the first year of the project show promising potential, laying a strong foundation for future work.
Early engagement with stakeholders, including patients, clinicians, and healthcare professionals, identified the challenges and barriers to using the BreathSense device in real-world settings. This feedback is useful to improve the device design and its integration into existing COPD management workflows. The goal is to ensure that the device is not only effective but also user-friendly and easy to incorporate into daily routines, making it a valuable tool for managing COPD exacerbations.
While the device is still in the development phase, the team has already made significant progress in understanding the regulatory requirements for its future clinical use. Ethical considerations have also been integrated into the project, particularly concerning the ethics related to the clinical use and the AI components that are part of our device. In consequence, an ethics plan has been developed to ensure the machine learning algorithms used in the BreathSense device 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, all in accordance with relevant ethical standards and regulations.
The most notable achievement was the successful development of a functional plasma-generating microchip, a core component of the BreathSense device. The microchip, developed using planar technology is the first step to enabling mass production of a breath analysis device for the management of COPD, ensuring that it can be offered at an attractive price point for the end user. The ability to generate plasma at a microscopic scale has been demonstrated, marking an essential step forward in the project. Supporting this major milestone, technical specifications for the supporting system were established, while a working prototype is being developed to provide a suitable plasma ignition condition and a controlled environment for precise testing, validation and further optimization of the future generation microchips. Although further refinements are still required, the initial results in the first year of the project show promising potential, laying a strong foundation for future work.
Early engagement with stakeholders, including patients, clinicians, and healthcare professionals, identified the challenges and barriers to using the BreathSense device in real-world settings. This feedback is useful to improve the device design and its integration into existing COPD management workflows. The goal is to ensure that the device is not only effective but also user-friendly and easy to incorporate into daily routines, making it a valuable tool for managing COPD exacerbations.
While the device is still in the development phase, the team has already made significant progress in understanding the regulatory requirements for its future clinical use. Ethical considerations have also been integrated into the project, particularly concerning the ethics related to the clinical use and the AI components that are part of our device. In consequence, an ethics plan has been developed to ensure the machine learning algorithms used in the BreathSense device 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, all in accordance with relevant ethical standards and regulations.
The BreathSense project has made great progress beyond existing technologies in two critical areas: miniaturized plasma emission spectroscopy and research into COPD management landscape.
The successful development of a plasma-generating microchip marks a significant milestone in miniaturizing plasma emission spectroscopy. This technology will offer sensitivity and specificity comparable to lab equipment like GC-MS, but with a much smaller footprint, lower cost and a user-friendly interface. Unlike electrochemical technologies, such as e-noses, BreathSense offers specific and accurate measurements of the chemical composition of gas. Beyond breath analysis, this technology has the potential to benefit other gas analysis applications, including environmental monitoring and industrial processes.
The project has made important progress in the area of remote COPD management. A key accomplishment is the comprehensive study of the COPD management landscape, which involved stakeholder mapping and a contextual analysis of healthcare systems. This research has provided a deeper understanding of the patient journey, current intervention strategies, and the needs of healthcare providers, patients, and other stakeholders in COPD care. The study also identified barriers and enablers of the adoption of new monitoring technologies, offering valuable insights for the integration of our technology in the COPD management workflow.
The successful development of a plasma-generating microchip marks a significant milestone in miniaturizing plasma emission spectroscopy. This technology will offer sensitivity and specificity comparable to lab equipment like GC-MS, but with a much smaller footprint, lower cost and a user-friendly interface. Unlike electrochemical technologies, such as e-noses, BreathSense offers specific and accurate measurements of the chemical composition of gas. Beyond breath analysis, this technology has the potential to benefit other gas analysis applications, including environmental monitoring and industrial processes.
The project has made important progress in the area of remote COPD management. A key accomplishment is the comprehensive study of the COPD management landscape, which involved stakeholder mapping and a contextual analysis of healthcare systems. This research has provided a deeper understanding of the patient journey, current intervention strategies, and the needs of healthcare providers, patients, and other stakeholders in COPD care. The study also identified barriers and enablers of the adoption of new monitoring technologies, offering valuable insights for the integration of our technology in the COPD management workflow.