DASHER: Detecting Absence Seizures Using a Hyperventilation and Eye Movement Recordings

Sponsor

Eysz, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06093490

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Enrollment

Location

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Absence Epilepsy, Childhood Absence Seizures Absence Epilepsy Epilepsy in Children Staring Seizures	Device: Eysz Hyperventilation Recorder

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 Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

A Mobile Health Application to Detect Absence Seizures Using Hyperventilation and Eye-Movement Recordings

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Absence Seizure Age 4-12, Typical Absence Seizure captured during hyperventilation	Device: Eysz Hyperventilation Recorder App used to guide and record hyperventilation
Control Group Age 4-12, Control Group without seizure activity during hyperventilation	Device: Eysz Hyperventilation Recorder App used to guide and record hyperventilation

Arm

Intervention/Treatment

Absence Seizure

Age 4-12, Typical Absence Seizure captured during hyperventilation

Device: Eysz Hyperventilation Recorder

App used to guide and record hyperventilation

Control Group

Age 4-12, Control Group without seizure activity during hyperventilation

Device: Eysz Hyperventilation Recorder

App used to guide and record hyperventilation

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 12 Years

Sexes Eligible for Study:

All

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