Topic
Improving health outcomes in areas such as early identification of infection, individual vaccine responses, and the monitoring of autoimmune conditions and immune-oncology therapies require medical approaches that transcend outdated, century-old practices for measuring inflammation, such as using fever as a primary indicator. These conventional methods often lack personalization and fail to account for the unique variability in individual immune responses, notifying the urgent need for individualized biomarkers of inflammation that leverage unique wearable sensor-based, medical grade, physiologic data from each individual.
Objective
To determine if subtle, individual changes in physiology due to innate immune system activation, induced by an intravenous bolus of lipopolysaccharide (LPS), and detectable through wearable sensors, can allow for the develop of a digital biomarker that correlates with serum inflammatory biomarkers.
Number of Participants
12 healthy volunteers
Study Design
For 3 days, while doing their routine activities, volunteers will wear a wrist wearable (Corsano CardioWatch 287-2) and two patch sensors. On the fourth day, the volunteers will report to the research center where they, after 5:1 randomization, will receive either low-dose, 1 ng/kg lipopolysaccharide (LPS), to elicit innate immune response or saline placebo under on-site continuous physiology monitoring and physician supervision. Serial blood sampling towards serum biomarker measures and the other for LPS/placebo administration. After completing the onsite procedures, volunteers will go home and return the next day for a final blood draw at the 24-hour time point.
Study center
Purdue University, West Lafayette, Indiana, USA
Start time, Duration
Start: Q1,2025 Study duration: 5 days
Interested in our Trial Programme?
Corsano Cardiowatch Bracelets enable continuous monitoring with multiple algorithms. Corsano is working closely with cardiologists, scientists, hospitals, patients, and research organisations. Scientific research demonstrates the legitimacy of Cardiowatch 287 algorithms.
We are currently performing pilots with selected clients. Contact us if you want to know more!
Corsano CardioWatch is a wrist worn medical grade multi sensor bracelet to capture up to 19 vital parameters. Primary use cases are 24/7 continuous clinical trials and remote patient monitoring.
The bracelet monitor offers flexibility to set data collection intervals by minute, by second or 25Hz, 32 Hz or 128 Hz. We measure Heart Rate, RR intervals, Breathing Rate, A-Fib detection, Skin Temperature, Activity and Sleep. SpO2, Core Body Temperature, ECG and Blood Pressure are in development.
Clinical accuracy is paramount for us. In addition to third parties' algorithms, i.e. from Philips, we run our proprietary algorithms to realize superior data accuracy. Corsano technology has been clinically validated in major academic hospitals. The bracelet is manufactured under ISO 13485 and CE-MDR compliance. The process for FDA Clearance has started.
Our end-to-end solution consists of light-weight and comfortable bracelets with a patient research portal. We have developed and produced over 200’000 devices. The Corsano platform has been optimized on connections, data buffers and battery life up to 15 days. We offer access to raw continuous high frequency data through API and cloud-to-cloud solutions.
The founders of Corsano Health have over 100 years of experience in the Swiss Watch industry, with deep experience about ergonomic design and materials for wearables that are worn 24/7.