For both heart failure and chronic kidney disease patients, it is important to diagnose microvascular dysfunction and monitor the deterioration of microvascular function in early phases of the disease progress. Our proposed technology, the HEMI-speckle system, is an integrated solution of two existing prototypes, namely, the multi-spectral optical sensory system (HEMI) and the speckle plethysmography (SPG) system. To understand the diagnostic value of these technologies for both HF and CKD populations, two clinical trials will be executed. At the same time, the new integrated solution will be developed. Prior to conducting the validation trial, adjustments can be made to existing individual technologies to ensure the trial is conducted properly in a patient population in a clinical setting. Lessons learnt from these clinical trials can be used a) for the development of the integrated HEMI-speckle system, b) to identify new digital biomarkers from the individual and integrated technology, c) to analyse the sensitivity and specificity of the two technologies for each population separately, and d) to prove the validity of the technologies for the early assessment of microvascular function in the target population. A third clinical trial will run in a later phase, when the HEMI-speckle prototype is ready. In this trial, the new technology will be verified on healthy volunteers and hypertensives, after the validation of the underlying technologies on a relevant patient population has been done. The additional new digital biomarkers obtained from the unique combination of the two individual technologies can be explored in this phase.
During the second reporting period, STIMULUS achieved its second and third milestones: M2, Ethics committee approval for clinical trials II, and M3, Recruitment closed for clinical trials I. By the end of the period, the TRL level of the HEMI and SPG devices have been improved after clinical trials I, to better suitability for clinical environments. This led to the final prototype devices for the clinical trials IIa and IIb. Additionally, the first functional prototype of the HEMI-speckle device has been created, and a first prototype of the smart toilet demonstrator has been developed and tested. The SPG and HEMI prototypes have been demonstrated at the European Society of Hypertension conference to clinicians and researchers. Datasets of measurements from healthy volunteers with the HEMI device and SPG device have been acquired and data processing algorithms have been developed. The first possible biomarkers for microcirculation function have been examined. The first results of these analyses have been presented at scientific conferences.
Additionally, the development of SMI-VCSEL miniature monolithic blood flow dynamics sensor started after a Hop-on partner joining the consortium in the second reporting period. During the reporting period, the design, assembly, and initial testing of the miniature monolithic SMI-VCSEL blood-flow dynamics sensor were carried out.
Health technology assessment (HTA) is an integral part of the project activities. One of the key roles of HTA is to provide prospective knowledge about the possible or probable consequences of new and emerging technologies. In the process, intended and non-intended impacts of the technology application are identified. Anticipating the spectrum of possible consequences of technology, at an early stage, helps to make good use of the potential of progress and to be able to minimize risks or even to avoid them. By the end of the second reporting period, the Ethical, Legal and Social Aspects (ELSA) have been addressed, firstly by conducting a literature review and complemented by a thorough analysis of the discussions amongst the relevant partners. The analysis is ongoing, and its findings will be documented in the forthcoming Deliverable 5.1 Report on Ethical, Legal and Social Assessment, to be delivered at the beginning of the next reporting period. Stakeholder engagement workshops involving healthcare professionals are being planned. STIMULUS uses a stakeholder-driven methodology to promote active participation and dialogue, enabling the co-creation of research outcomes. This approach ensures that the research conducted within the project reflects the values, needs and expectations of society.
