Detecting Absence Seizures Using Hyperventilation In a Home Environment

Abstract Eysz, Inc. is developing a mobile health (mHealth) platform, the Eysz HV Recorder, to remotely diagnose and monitor childhood absence epilepsy (CAE) to improve patient management and reduce the time to seizure freedom. Early treatment of CAE is critical, but absence seizures are currently challenging to identify, and diagnosis is frequently delayed. The gold standard for seizure detection is video EEG (VEEG), but VEEG has several drawbacks for treatment management of CAE, causing most clinicians to rely on self-reports, even though studies have shown that patients and caregivers report only about 6% and 14% of all absence seizures, respectively. Thus, there is an urgent need for an accurate remote monitoring to assist clinicians in assessing treatment response over time for patients with CAE. The Eysz HV Recorder is an mHealth app used to assist clinicians in the diagnosis of CAE and is currently being used in pediatric and child neurology clinics and undergoing a post-marketing study. The Eysz app guides patients through hyperventilation (HV) while giving continuous feedback to safely and effectively provoke absence seizures while video-recording the patient's face. The recording is then analyzed by a child neurologist and a report is sent to the treating physician. Our preliminary results from our post-marketing clinical study have shown that our video analyses have a sensitivity close to 100% and a specificity of 92% compared to VEEG for seizures greater than 7 seconds in duration. This Fast Track SBIR project seeks to develop and test a home-based version of the Eysz HV Recorder, enabling more frequent and convenient assessment of the patient’s treatment regimen. The FDA has requested additional testing prior to in-home use of the Eysz HV Recorder; therefore, this Fast Track proposal seeks to develop an in-home version of the app and validate safety protocols prior to launching an in-home study that will support FDA clearance of the app. Phase I Aim 1: Define and validate user and system requirements to ensure safety, usability, data quality, and regulatory compliance. Phase I Aim 2: Build and validate the software and training materials, using a standard risk-based software development approach. We will also develop training and educational materials for caregivers. Phase I Aim 3: Test safety procedures and app usability in a clinical setting. We will iteratively introduce the app and training materials to cohorts of users in a clinical setting to evaluate usability and data quality. After meeting our Go/No Go Milestones for Phase I, we will proceed to Phase II Aim 4: Perform an at-home study to assess usability, adherence, diagnostic accuracy and safety. This pivotal study will test the use of the app by caregivers in real-life home environments. This study will provide key data to support FDA clearance of the app and will set the stage for its future deployment as a tool for at-home monitoring and management of CAE.