Detecting Absence Seizures Using Hyperventilation and Eye Movement Recordings

Recruiting

• Conditions: Staring; Absence Epilepsy; Absence Epilepsy, Childhood; Epilepsy in Children; Seizures; Absence Seizures
• Interventions: Device: Eysz Hyperventilation Recorder

• Registration Number: NCT06093490
• Lead Sponsor: Eysz, Inc.

Brief Summary

This study is being done to find out if a smartphone app can identify absence seizures. Children who have a history of absence seizures, as well as children without any seizure history, will be testing out the app. If participating the child will be guided through hyperventilation, an activity that asks the child to take quick, deep breaths. The app will record video of the child's face and sounds they make during hyperventilation. Hyperventilation is a safe and established technique frequently used during EEG (electroencephalogram) to encourage seizure occurrence. The App will be used during a regularly scheduled EEG.

Detailed Description

This observational study focuses on validating the use of the Eysz mHealth App - a smartphone-based tool for guided Hyperventilation (HV) and data collection - to aid clinicians in identifying absence seizures in people at risk for childhood absence epilepsy (CAE). The Eysz mHealth app will guide users through HV via interactive graphics while capturing audio and video data using smartphone sensors (e.g., camera, microphone) from which eye movements, facial biometrics/ expressions, number and length of exhales will be extracted.

The goal of this observational study is to determine an epileptologist's performance in identifying HV-induced absence seizures using video data collected from a smartphone when compared to the gold standard interpretation of the EEG. The exploratory goal is to develop machine learning based algorithms to identify HV-induced seizures.

Study Timeline

• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-23
• Study Start: 2023-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• typical absence seizure during use of the Eysz Hyperventilation Recorder or Control

Exclusion Criteria

• Other seizure type besides typical absence seizure during use of the Eysz Hyperventilation Recorder
• subclinical seizure activity
• inability to participate with study procedures
• contraindications to hyperventilation including history of subarachnoid hemorrhage, sickle cell anemia, recent cerebrovascular accident or myocardial infarction, significant cardiopulmonary disease, active asthma, known aneurysm, known moyamoya disease, or pregnancy.
• People who have a history of generalized tonic clonic convulsions (GTCs) provoked by hyperventilation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Eysz Hyperventilation Recorder	Age 4-12, Control Group without seizure activity during hyperventilation
Absence Seizure	Eysz Hyperventilation Recorder	Age 4-12, Typical Absence Seizure captured during hyperventilation

Primary Outcome Measures

Name	Time	Method
Accuracy of Eysz Hyperventilation (HV) Recorder Compared to video EEG (VEEG)	epileptologist review of 5 minutes of use of the Eysz Hyperventilation Recorder	Voluntary HV triggers seizures in \>90% of people with absence epilepsy and is a standard clinical procedure to assist in diagnosing and monitoring absence epilepsy. Clinical studies have shown HV to be a safe and effective procedure. This study focuses demonstrating the accuracy of the physician read of a smartphone video generated by the Eysz Hyperventilation (HV) Recorder- a smartphone-based tool for guided HV and video data collection. Three epileptologists will review the VEEG during use of the Eysz HV Recorder to identify typical absence seizures. Three independent epileptologists will review the concurrently generated video from the Eysz HV Recorder to identify typical absence seizures.; Our primary endpoint is that the lower bound of the 95% confidence interval of the accuracy of the majority classification of the smartphone video is ≥ 75% in comparison to the majority classification of the VEEG by 3 independent expert reviewers.

Trial Locations

Locations (1)

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States