Topic
Investigation of Corsano CardioWatch 287-2B devices for monitoring Elhers-Danlos Syndrome (EDS) patient physiology in both stable and symptomatic states for digital biomarker and personalized predictive model development
Objective
To characterize and predict the physiologic changes that occur with POTS or Orthostatic Hypotension (OH) symptom onset in a 30-day ambulatory monitoring study
Number of Participants
40
Study Design
A feasibility study with healthy volunteers and volunteers diagnosed with hypermobile Ehlers-Danlos Syndrome recruited from Indiana University Health Gastrointestinal and Genetics Clinics. Volunteers will wear a Corsano CardioWatch 287-2B for 30 days while journaling time and description of symptoms. Physiologic data recorded with the CardioWatch will be analyzed to develop metrics and models for classifying and quantifying underlying autonomic function/dysfunction and symptom type. Current prescribed cardiovascular altering medication use by study volunteers will be closely analyzed with respect to symptoms and physiologic data to identify how these pharmaceutical influence physiologic activity/function as measured by the CardioWatch. These analyses of both stable and symptomatic states could lead to the development of new digital biomarkers and the development of personalized predictive models that may serve as feedback to neuromodulation devices or other active medical device-based interventions.
Study center
Indiana University School of Medicine, Indianapolis, IN, and Purdue University, West Lafayette, IN
Principle Investigator
Matthew Ward, PhD (Purdue PI) and Clair Francomano, MD (IUSM PI)
Start time, Duration
July 2024, 30-day ambulatory recordings (enrollment over a 18-month period)
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.