The STIMULUS project aims to develop a new non-invasive, low-cost, and easy-to-use optical monitoring technology that can measure new digital biomarkers from microcirculation for the early detection of cardiovascular diseases. The novel technology will enable earlier detection of heart failure and chronic kidney disease, which will substantially reduce cardiovascular events in the European population. It will allow patients with microvascular dysfunction to be monitored and deterioration in their microvascular function to be detected in early phases of the disease progression.

The project aims to advance the field of cardiovascular monitoring. The technology developed for this purpose, the “HEMI-speckle system,” will be based on an integrated solution of two existing prototypes: a multispectral optical sensor system and a speckle plethysmography system. The existing prototype technologies will be adapted prior to conducting a validation study to ensure proper conduct in a clinical setting. The knowledge gained from these clinical trials can be used to

1. develop the integrated HEMI-speckle system,
2. identify new digital biomarkers from the individual technologies and the integrated technology,
3. analyze the sensitivity and specificity of the two technologies for each study group separately, and
4. prove the validity of the technologies for the early assessment of microvascular function.

To determine the diagnostic value of these technologies for both the heart failure and chronic kidney disease groups, two clinical trials will be conducted. 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 tested in healthy volunteers and hypertensives, after the underlying technologies have been validated in a relevant patient population. The new digital biomarkers of the HEMI-speckle system, resulting from the unique combination of the two individual technologies, can be explored in this phase. The HEMI-speckle system can be integrated into a pulse oximeter and/or a smart toilet.

In parallel, an earlier health technology assessment (HTA) will be conducted. The HTA provides prospective knowledge about the possible or probable consequences of the new technologies. In the process, intended and unintended impacts of technology are identified. Considering possible consequences at an early stage helps exploit the potential of progress and minimize or even avoid risks.

In the project, ITAS will be responsible for work package 5 (WP5): the health technology assessment.

WP5 has three main objectives:

• to conduct an early HTA focusing on the ethical, legal, and social aspects (ELSA) related to the development of the finger clip and the smart toilet demonstrator,
• to evaluate the technology according to the Medical Device Regulation,
• to organize co-creation workshops to ensure that the technology development meets users’ needs.

These objectives will be achieved by:

1. operationalizing the ELSA related to the development of the technology,
2. conducting workshops with individual patients, patient groups, and healthcare professionals,
3. conducting user centered co-creation workshops, and
4. conducting a Medical Device Regulation assessment.

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