Early Warning Wearable for Sleep Strokes | zeit

The Challenge of Wake-Up Strokes and Zeit Medical’s Solution

Individuals predisposed to stroke are typically aware of the warning signs, yet remain vulnerable during sleep. This leads to thousands of undiagnosed “wake-up strokes,” often identified only hours after their occurrence. Zeit Medical is developing a brain-monitoring wearable designed to detect these events and expedite access to crucial medical intervention, potentially minimizing damage and improving patient outcomes.

The Evolution of Stroke Treatment

Historically, treatment options for stroke were limited. However, the introduction of effective medications in the 1990s, coupled with subsequent surgical advancements, dramatically altered the landscape. Crucially, both therapies are most effective when administered within a narrow window following stroke onset.

Zeit Medical’s Origin and Focus

Orestis Vardoulis and Urs Naber founded Zeit (“time”) after observing the significant resources dedicated to reducing delays in stroke care – specifically, the time between a 911 call and the delivery of necessary treatment. The company participated in Y Combinator’s Summer 2021 program.

Addressing the Untapped Potential

“The ability to act swiftly after a stroke became paramount,” explained Naber. “Brain tissue begins to deteriorate immediately upon stroke onset, making time the most critical factor.” He further noted that considerable effort has been invested in minimizing delays from the initial 911 call through hospital treatment, but the period before emergency services are contacted remains largely unaddressed – a gap Zeit Medical aims to fill.

Expanding Beyond Wake-Up Strokes: Monitoring in the Operating Room

The potential for early stroke detection extends beyond individuals unaware of their condition. A similar need exists within the operating room environment.

Leveraging Expertise in EEG Analysis

Surgeons and nurses routinely monitor patients’ vital signs during surgery, including brainwave activity via EEG, to identify potential stroke indicators. Vardoulis stated, “Experienced neurologists visually recognize specific patterns; we’ve developed a tool to automate this detection process.” Collaboration with leading neurologists was instrumental in identifying key signal features for accurate and efficient analysis.

The Zeit Wearable: Design and Functionality

The team engineered a comfortable, wearable headband incorporating a compact EEG. This device continuously monitors brain signals, transmitting data to a smartphone app. A machine learning model, trained on established patterns, analyzes the data and triggers an alert to the user and designated caregivers upon detection of anomalies. The system can also be configured to automatically contact emergency services.

Validation Through Operating Room Data

“The majority of our data originates from the OR,” Vardoulis clarified, “where findings can be immediately validated.” Their algorithm has demonstrated a high degree of accuracy in identifying events within the operating room, with zero false positives.

Transitioning to Home Monitoring and Clinical Trials

The team believes this performance will translate effectively to home use, where fewer confounding variables are present. They are currently conducting studies with individuals at high risk of stroke, specifically those in the immediate aftermath of a stroke or related event – a period characterized by increased vulnerability to subsequent occurrences.

Path to Commercialization and FDA Approval

“We are currently distributing a research kit, including the headband and smartphone, to study participants for nightly use,” Vardoulis reported. Zeit Medical anticipates a commercial launch in 2023 and is actively collaborating with the FDA to establish the necessary clinical evidence for regulatory clearance.

Breakthrough Device Designation

The company has received a “Breakthrough Device” classification, similar to BrainQ, which will expedite the testing and certification process.

Global Implications and Accessibility

“We plan to launch initially in the U.S., but recognize a global need,” Naber stated. “Countries with aging populations and limited disability support systems stand to benefit significantly.” The device has the potential to reduce the burden and cost associated with at-home and disability care.

Future Directions and Potential Applications

The current focus is on data collection and partnerships to facilitate a large-scale study, essential for securing insurance reimbursement. While currently focused on stroke detection, the underlying technology could be adapted to monitor other neurological conditions.

A Vision for Comprehensive Stroke Care

“Our goal is to provide this device to everyone at risk of stroke,” concluded Vardoulis. “We believe it represents a crucial missing component in the stroke care pathway.”