Detecting Absence Seizures Using Hyperventilation and Eye Movement Recordings

NCT ID: NCT06093490

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-07-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Absence Seizure

Age 4-12, Typical Absence Seizure captured during hyperventilation

Eysz Hyperventilation Recorder

Intervention Type DEVICE

App used to guide and record hyperventilation

Control Group

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

Eysz Hyperventilation Recorder

Intervention Type DEVICE

App used to guide and record hyperventilation

Interventions

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Eysz Hyperventilation Recorder

App used to guide and record hyperventilation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Eysz, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Rachel Kuperman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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1R43NS129363

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R43NS129363

Identifier Type: NIH

Identifier Source: org_study_id

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