Principal investigator, Amar Basu, professor of electrical and computer engineering at Wayne State University and CEO of TRACE Biometrics LLC, has received a National Institute on Aging R21 award to further validate the TRACE sensor against gold standard clinical orthostatic measures, which will build upon the pilot award’s work towards securing FDA clearance.
Project Summary: Orthostatic disorders, including orthostatic hypotension (OH), disproportionately affect older adults, presenting in 30% of older adults and up to 70% of nursing home residents. As OH is a major risk factor for syncope, falls, and cognitive decline, medical agencies stress the public health need for monitoring orthostatic vital signs (OVS) in at-risk individuals. This proposal investigates an NIA award-winning wearable device called TRACE, which addresses fundamental limitations of the current clinical standard, the blood pressure (BP) cuff: 1) The BP cuff measures central BP, but it is known that the root cause of orthostatic symptoms is a lack of blood flow to the head. TRACE’s unique blood volume-based metrics are predictive of orthostatic symptoms, whereas BP is not. 2) BP cuffs cannot capture the rapid hemodynamics of the initial orthostasis response (first 10-30 seconds), a predictive marker for adverse outcomes. Continuous BP and transcranial Doppler (TCD) can capture these dynamics, but their cost make them impractical for routine monitoring. TRACE offers real-time monitoring in a low cost wearable. 3) TRACE offers multiple metrics to aid clinicians in a specific diagnosis. Our long-term goal is to address the underdiagnosis and mismanagement of orthostatic disorders using the TRACE remote OVS monitoring platform. The objective of this application is to validate TRACE’s 4 novel orthostatic metrics against the gold standard of perfusion measurement, TCD. Our central hypothesis is that normalized metrics will match their counterpart TCD metrics, and both will be more predictive of self-reported OH symptoms than the BP cuff. The team includes PI Prof. Amar Basu, an electrical/biomedical engineer who developed TRACE and has >15 years of experience in wearable sensors; Dr. Joseph Miller, an emergency medicine physician with expertise in orthostatic measurements by transcranial Doppler; and Dr. Paul Kilgore, an expert in clinical study design. Henry Ford Hospital and the Wayne State Integrative Biosciences Center will provide participant recruitment and facilities. Aim 1 will evaluate TRACE’s 4 orthostatic metrics that quantify relative physiologic changes during orthostasis. Their robustness to confounding factors will be evaluated in 25 older adults by measuring the agreement between two TRACE sensors, one on each earlobe, during active stand tests. Aim 2 will compare TRACE blood volume metrics with TCD perfusion metrics. We will perform tilt table and active stand tests in 100 older adults, monitoring simultaneously with TRACE, TCD, BP, and continuous BP. Aim 2 will test our central hypothesis described above. The proposed work could have a transformative impact in managing incurable orthostatic disorders like Neurogenic OH. TRACE brings perfusion-based metrics in a wearable form factor that can assess orthostatic metrics every time an individual stands. Temporally rich information can empower clinicians and patients to understand the effect of triggers (large meals, poor hydration), and the efficacy of interventions (crossing legs, compression stockings), improving patient outcomes.
Project Narrative Orthostatic disorders affect 30% of older adults and 70% of nursing homes residents, and increase the risk for fall-related injuries, cognitive decline, and other co-morbidities. The current consensus method of diagnosing and managing orthostatic disorders, based on the blood pressure cuff, has fundamental limitations, including the inability to measure the root cause of orthostatic symptoms, lack of blood perfusion to the head. This project will validate a novel wearable sensor that addresses these limitations and provides clinicians and patients with a powerful home-based platform to better manage orthostatic disorders and improve patient outcomes.
Source: 1R21AG088945-01 on NIH RePORTER