Research Project
9346733
ABSTRACT TessaTM is validated medical device wearable capable of providing clinical sleep quality metrics for multiple nights to assess the efficacy of a sleep disorder treatment. Tessa records the forehead EEG to stage sleep in an automated report that tracks changes in sleep architecture before and after a treatment for many sleep disorders such as obstructive sleep apnea and insomnia. There is a trend for tracking one?s sleep health at home with unvalidated consumer electronic wearables. Yet, sleep diaries, actigraphy watches, and smart phone sleep apps have been shown to be inadequate, inaccurate, and have poor specificity as compared to polysomnography (PSG). There is clear need for a validated medical device that can provide primary care physicians and sleep medicine specialists with clinically-actionable, quantitative information on a person?s sleep architecture with the sensitivity and specificity of PSG for multiple nights in the user?s home. TessaTM is a medical device worn on the forehead at night to track sleep To address this clear medical need, Epitel has developed a prototype quality by monitoring the EEG. Its of its Tessa device that records EEG from two gold electrodes centered form and compliance make it above the eyes with a common reference along the midline based on comfortable to wear and sleep with for frontal scalp locations that have been shown to contain the EEG multiple nights in the user?s home. signatures of sleep architecture, including eye movements (Stepnowsky et al, 2013; Huang et al, 2014; Popovic et al, 2014). Tessa is simply placed on the forehead each night where it records the EEG signatures of the different sleep stages. Each night, a fresh conductive and adhesive ?sticker? is placed on the bottom of the device. Each morning, Tessa is removed from the forehead and the conductive/adhesive sticker is peeled off and thrown away. After use, Tessa is mailed back to Epitel where accredited sleep technicians generate a personalized sleep quality report that becomes part of the user?s electronic medical records. Tessa is semi-disposable, designed The goal of this Phase I study is to demonstrate the feasibility of Tessa to be used for up to 90 nights. A in two scenarios inside and outside the Sleep-Wake Center at the nightly disposable conductive and University of Utah: adhesive sticker (not shown) is i. Tessa records functionally equivalent EEG sleep metric data to placed over the gold electrodes the ?gold-standard? polysomnography (bottom). Tessa will be molded in a ii. Demonstrate Tessa feasibility for at-home monitoring flexible medical-grade polyamide to create a robust waterproof interface With the Tessa prototype we have successfully recorded the five suitable for the rigors of home use. different stages of sleep over multiple nights. In Aim 1 we will compare Tessa recordings to the gold standard PSG in the Sleep-Wake Center to demonstrate sensitivity and specificity for accurately identifying the different stages of sleep. In Aim 2 we will take Tessa out of the Sleep Center and into the person?s home environment to demonstrate the feasibility of making EEG recordings with Tessa for 10 nights. With this feasibility data, Epitel will in Phase II, finalize the design to make Tessa suitable for the rigors of home use, culminating in a validation clinical trial for FDA-clearance through the 510(k) process. Recording 2-Ch EEG from the forehead with Tessa, challenges and seeks to shift clinical EEG recordings from the Tessa prototype show the different sleep quality monitoring practice by bringing stages of sleep architecture, demonstrating the ability to stage multi-night sleep staging to the user?s home. sleep from two channels of frontal EEG.
