Absence Epilepsy, ChildhoodDASHERNCT06093490
Detecting Absence Seizures Using Hyperventilation and Eye Movement Recordings
An observational study of Absence Epilepsy, Childhood and Absence Seizures, run by Eysz, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Absence Epilepsy, Childhood, Absence Seizures, Absence Epilepsy
- What is being tested?
- Eysz Hyperventilation Recorder
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Child
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
Who may be able to join
- typical absence seizure during use of the Eysz Hyperventilation Recorder or Control
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital
Cincinnati, Ohio, 045229
About this study
Official 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.
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.
- Conditions
- Absence Epilepsy, Childhood, Absence Seizures, Absence Epilepsy, Epilepsy in Children, Staring, Seizures
- Being tested
- Eysz Hyperventilation Recorder
- Keywords
- absence seizures, absence epilepsy, hyperventilation, staring spells
- Medical subject headings
- Epilepsy, Absence, Seizures, Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eysz Hyperventilation RecorderDevice
App used to guide and record hyperventilation
| Study group | Role | What they receive |
|---|---|---|
| Absence Seizure | Age 4-12, Typical Absence Seizure captured during hyperventilation Receives: Device: Eysz Hyperventilation Recorder | |
| Control Group | Age 4-12, Control Group without seizure activity during hyperventilation Receives: Device: Eysz Hyperventilation Recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: epileptologist review of 5 minutes of use of the Eysz Hyperventilation Recorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Dec 2023
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absence Epilepsy, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eysz, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Rachel Kuperman, Eysz, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093490
- Sponsor's protocol ID
- 1R43NS129363
- Other IDs
- 1R43NS129363
- Acronym
- DASHER
- Status last verified
- Oct 2025
- First submitted
- 16 Oct 2023
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Health Application to Detect Absence Seizures Using Hyperventilation and Eye-Movement Recordings
- ClinicalTrials.gov ID
- NCT06093490
- Acronym / sponsor ID
- DASHER / 1R43NS129363
- Conditions
- Absence Epilepsy, Childhood, Absence Seizures, Absence Epilepsy, Epilepsy in Children, Staring, Seizures
- Keywords
- absence seizures, absence epilepsy, hyperventilation, staring spells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Eysz, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absence Seizure | – | Device: Eysz Hyperventilation RecorderAge 4-12, Typical Absence Seizure captured during hyperventilation |
| Control Group | – | Device: Eysz Hyperventilation RecorderAge 4-12, Control Group without seizure activity during hyperventilation |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- typical absence seizure during use of the Eysz Hyperventilation Recorder or Control
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eysz Hyperventilation RecorderApp used to guide and record hyperventilation | Device | Absence Seizure, Control Group |
Primary outcome
Accuracy of Eysz Hyperventilation (HV) Recorder Compared to video EEG (VEEG)
Time frame: epileptologist review of 5 minutes of use of the Eysz Hyperventilation Recorder
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Absence Epilepsy, Childhood and Absence Seizures, run by Eysz, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Eysz Hyperventilation (HV) Recorder Compared to video EEG (VEEG) (time frame: epileptologist review of 5 minutes of use of the Eysz Hyperventilation Recorder). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.