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Detecting Absence Seizures Using Hyperventilation and Eye Movement Recordings (DASHER)

E

Eysz

Status

Completed

Conditions

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

Treatments

Device: Eysz Hyperventilation Recorder

Study type

Observational

Funder types

Industry
NIH

Identifiers

NCT06093490
1R43NS129363 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

All

Ages

4 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

65 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Parth Amin, BE; Rachel Kuperman, MD

Data sourced from clinicaltrials.gov

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