ClinicalTrials.gg
CompletedNCT06093490DASHERUpdated Oct 15, 2025

Detecting Absence Seizures Using Hyperventilation and Eye Movement Recordings

An observational study in Absence Epilepsy, Childhood, Absence Seizures and Absence Epilepsy, sponsored by Eysz, Inc.. Completed at 1 site in United States. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-10-15.

Sponsored by Eysz, Inc. · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
65
Ages
4 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • absence seizures
  • absence epilepsy
  • hyperventilation
  • staring spells
03

In context

Epilepsy, Absence

24 studies on the registry are indexed under Epilepsy, Absence; 2 are open to participants now.

Browse Epilepsy, Absence studies →

Lead sponsor

Eysz, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 12 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
65 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceEysz Hyperventilation Recorder

    App used to guide and record hyperventilation

06

What researchers measure

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.

    Time frame: epileptologist review of 5 minutes of use of the Eysz Hyperventilation Recorder

07

Study locations

1 site
  • Cincinnati Children's Hospital
    Cincinnati, Ohio 045229, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06093490
Lead sponsor
Eysz, Inc.
Responsible party
Rachel Kuperman (Principal Investigator, Eysz, Inc.) — Principal investigator
First posted
Oct 23, 2023
Start date
Dec 1, 2023
Primary completion
Jun 30, 2025
Completion
Jul 30, 2025
Last update
Oct 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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