Seizures Clinical Trial
— DASHEROfficial title:
A Mobile Health Application to Detect Absence Seizures Using Hyperventilation and Eye-Movement Recordings
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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 4 Years to 12 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Eysz, Inc. | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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