Detecting Absence Seizures Using Hyperventilation and Eye Movement Recordings

NCT06093490 | Completed FDA Device

• 1 other identifier: 1R43NS129363
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Absence Epilepsy, Childhood; Absence Seizures; Absence Epilepsy; Epilepsy in Children; Staring; Seizures

Keywords

absence seizures; absence epilepsy; hyperventilation; staring spells

Outcome Measures

Primary Outcomes (1)

• Accuracy of Eysz Hyperventilation (HV) Recorder Compared to video EEG (VEEG)

  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.

  epileptologist review of 5 minutes of use of the Eysz Hyperventilation Recorder

Study Arms (2)

Absence Seizure

Age 4-12, Typical Absence Seizure captured during hyperventilation

Device: Eysz Hyperventilation Recorder

Control Group

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

Device: Eysz Hyperventilation Recorder

Interventions

Eysz Hyperventilation Recorder DEVICE

App used to guide and record hyperventilation

Absence Seizure; Control Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children undergoing routine EEG as part of clinical care at risk or known to have childhood absence epilepsy who will be undergoing hyperventilation

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eysz, Inc.: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 045229, United States

Location

MeSH Terms

Conditions

Epilepsy, Absence; Seizures; Hyperventilation

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: December 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)