Continuous Non-Invasive Blood Pressure during Sleep as a Cardiovascular Biomarker

Blood pressure (BP) is one of the strongest risk factors for cardiovascular disease (CVD) and still cannot be monitored in a continuous and unobtrusive manner due to technological limitations, leaving significant gaps in evaluating CVD risk. Continuous BP monitoring during sleep may be crucial in the discovery of new CVD biomarkers for two primary reasons: 1. sleep is a more controlled-environment than the active periods of daytime and 2. the autonomic nervous system undergoes significant changes during sleep that are essential for restorative processes. Disruptions to the autonomic function, or imbalance between the sympathetic and parasympathetic activity, are prevalent in CVD, leading to higher frequency and magnitude of BP fluctuations and overall increased stress to the cardiovascular (CV) system. Furthermore, because of the strong relationship between sleep disorders and CVD, measuring BP during sleep can identify underlying mechanisms and potential causal relationships. Current methods to measure BP in sleep use intermittent cuff-based monitors, leaving lengthy unmonitored gaps between measurements. However, rapid BP fluctuations occurring in spans of tens of seconds can be significant. Many devices have recently been developed that attempt to measure BP non- invasively and continuously, but no technology has demonstrated the accuracy, responsiveness, usability and cost-effectiveness to fill the unmet need. This proposed project builds upon the company’s core beat-to-beat BP sensing technology to develop VeriSleep, a wearable device that quantifies CV burden, or total work the heart experiences in real-time, in order to provide a stronger and more direct biomarker for CV health. To do so, a robust device will be built that can withstand the rigors of the nighttime environment and measure absolute and relative changes of BP in mmHg. The project also seeks to validate the core technology’s ability to track transient BP surges in healthy individuals undergoing induced hypoxia and breathing maneuvers. Finally, the project will use the core technology to evaluate differences between healthy and non-healthy (apneic) patients based on metrics derived from the continuous BP measurements. The proposed project represents the first of its kind technology to directly measure continuous BP during sleep, enabling classification of CV conditions based on CV burden. This will refine our understanding of CVD, providing deeper insights into this complex condition and potentially enabling more personalized approaches.