EpilepsyWESPGNCT07139457
Wearable Epileptic Seizure Prediction and Alert Glasses Based on Neuromorphic Computing
A study testing Wearable seizure prediction and alert glasses in people with Epilepsy and Epileptic Seizures, run by Oman Ministry of Health at 1 site in Oman.
Trial summary
The NEXA study aims to evaluate a new wearable EEG device designed as smart glasses with dry electrodes positioned according to the 10-20 system. The device captures real-time brain signals to detect patterns that may predict seizures, helping people with epilepsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Epileptic Seizures, Focal Epilepsy
- What is being tested?
- Wearable seizure prediction and alert glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteOman
- Study dates
- 10 Aug 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) with a confirmed epilepsy diagnosis by a neurologist or epilepsy specialist.
- History of active seizures within the last year, under stable treatment (medications, VNS, diet, or surgery) for at least 3 months.
- Capacity to provide informed consent (or via legal representative if cognitively impaired).
- Willingness to participate and sign consent.
- Residents of Oman attending Khoula Hospital or affiliated clinics.
- Stable general health without acute or severe comorbidities.
- Ability and willingness to attend study visits and follow protocols.
Who cannot join
- Seizures from non-epileptic causes (e.g., psychogenic, metabolic, tumors).
- Under 18 years of age.
- Severe cognitive impairment preventing consent or protocol adherence.
- Pregnant or planning pregnancy during the study.
- Severe uncontrolled medical conditions (e.g., heart disease, cancer).
- History of non-compliance with epilepsy treatment or follow-ups.
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- Severe psychiatric disorders affecting participation or safety.
- History of substance abuse interfering with study adherence.
- Known allergies or hypersensitivity to study medications or procedures.
Trial locations and contacts
1 site in 1 country.
About this study
The NEXA study aims to evaluate a new wearable EEG device designed as smart glasses with dry electrodes positioned according to the 10-20 system. The device captures real-time brain signals to detect patterns that may predict seizures, helping people with epilepsy. This study will test the device's safety, performance, and usability before seeking regulatory approval, including FDA clearance. The NEXA device is investigational and not yet approved by the U.S. FDA. The study will involve human participants who will wear the device while data is collected and analyzed. Results will help improve the device and support future certification for medical use.
Read the detailed description
The NEXA Study is a prospective observational clinical trial designed to evaluate the safety, comfort, and performance of the NEXA wearable EEG device in patients with epilepsy. NEXA uses an innovative dry electrode system (two dome-shaped electrodes at the front and two spiked electrodes above the ears) aligned with the 10-20 EEG placement system to capture high-quality brain signals without the need for gels. The device integrates real-time artifact removal algorithms and a low-power neuromorphic chip for seizure detection and prediction. The study will compare NEXA's performance against standard EEG monitoring in hospital settings across Oman, with the primary goal of determining its accuracy in seizure detection and prediction. Secondary outcomes include electrode comfort, usability, compliance, and safety. Data from this study will support regulatory submissions and demonstrate NEXA's potential as a practical and reliable solution for continuous EEG monitoring.
- Conditions
- Epilepsy, Epileptic Seizures, Focal Epilepsy
- Being tested
- Wearable seizure prediction and alert glasses
- Medical subject headings
- Epilepsy, Seizures, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable seizure prediction and alert glassesDevice
Also called NEXA glasses, wearable EEG glasses, neuromorphic seizure prediction device
A glasses-based wearable EEG system using the international 10-20 electrode placement standard with 4 dry spiked electrodes at F7, F8, T3 and T4. The device integrates neuromorphic computing for real-time seizure prediction, an artifact removal algorithm, and multi-modal alerts (vibration, light, sound). Data is logged for model improvement. The system is intended for continuous use in both hospital-monitored and daily-life settings.
| Study group | Role | What they receive |
|---|---|---|
| Young adults | Experimental | Participants aged 18-30 (equal male and female distribution) who will wear the NEXA seizure prediction glasses during both hospital-monitored and daily-life phases. Intervention involves continuous EEG monitoring, real-time seizure prediction, and alert notifications. Receives: Device: Wearable seizure prediction and alert glasses |
| middle-aged adults | Experimental | Participants aged 31-60 (equal male and female distribution) who will wear the NEXA seizure prediction glasses during both hospital-monitored and daily-life phases. Intervention involves continuous EEG monitoring, real-time seizure prediction, and alert notifications. Receives: Device: Wearable seizure prediction and alert glasses |
| Elderly adults | Experimental | Participants aged 60+ (equal male and female distribution) who will wear the NEXA seizure prediction glasses during both hospital-monitored and daily-life phases. Intervention involves continuous EEG monitoring, real-time seizure prediction, and alert notifications. Receives: Device: Wearable seizure prediction and alert glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate Seizure Detection in Real-World Patient Settings
Measure the ability of the NEXA wearable EEG glasses to detect epileptic seizures in real-world patient settings with a target accuracy of ≥95%, using simultaneous hospital EEG recordings as the reference standard.
Measured: From start of patient data collection until end of clinical trial (estimated 3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start10 Aug 2025
- Primary completion20 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Ministry of Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Said Al-Mawali, PhD, Principal investigator, Oman Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139457
- Sponsor's protocol ID
- MoH/CSR/25/29835
- Other IDs
- Khoula Hospital
- Acronym
- WESPG
- Status last verified
- Oct 2025
- First submitted
- 17 Aug 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing is on permission basis based on Omani Ministry of Health policies.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Epileptic Seizure Prediction and Alert Glasses Based on Neuromorphic Computing
- ClinicalTrials.gov ID
- NCT07139457
- Acronym / sponsor ID
- WESPG / MoH/CSR/25/29835
- Conditions
- Epilepsy, Epileptic Seizures, Focal Epilepsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Oman Ministry of HealthOther government
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Aug 2025 (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.
The NEXA study aims to evaluate a new wearable EEG device designed as smart glasses with dry electrodes positioned according to the 10-20 system. The device captures real-time brain signals to detect patterns that may predict seizures, helping people with epilepsy. This study will test the device's safety, performance, and usability before seeking regulatory approval, including FDA clearance. The NEXA device is investigational and not yet approved by the U.S. FDA. The study will involve human participants who will wear the device while data is collected and analyzed. Results will help improve the device and support future certification for medical use.
Detailed description
The NEXA Study is a prospective observational clinical trial designed to evaluate the safety, comfort, and performance of the NEXA wearable EEG device in patients with epilepsy. NEXA uses an innovative dry electrode system (two dome-shaped electrodes at the front and two spiked electrodes above the ears) aligned with the 10-20 EEG placement system to capture high-quality brain signals without the need for gels. The device integrates real-time artifact removal algorithms and a low-power neuromorphic chip for seizure detection and prediction. The study will compare NEXA's performance against standard EEG monitoring in hospital settings across Oman, with the primary goal of determining its accuracy in seizure detection and prediction. Secondary outcomes include electrode comfort, usability, compliance, and safety. Data from this study will support regulatory submissions and demonstrate NEXA's potential as a practical and reliable solution for continuous EEG monitoring.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Young adults | Experimental | Device: Wearable seizure prediction and alert glassesParticipants aged 18-30 (equal male and female distribution) who will wear the NEXA seizure prediction glasses during both hospital-monitored and daily-life phases. Intervention involves continuous EEG monitoring, real-time seizure prediction, and alert notifications. |
| middle-aged adults | Experimental | Device: Wearable seizure prediction and alert glassesParticipants aged 31-60 (equal male and female distribution) who will wear the NEXA seizure prediction glasses during both hospital-monitored and daily-life phases. Intervention involves continuous EEG monitoring, real-time seizure prediction, and alert notifications. |
| Elderly adults | Experimental | Device: Wearable seizure prediction and alert glassesParticipants aged 60+ (equal male and female distribution) who will wear the NEXA seizure prediction glasses during both hospital-monitored and daily-life phases. Intervention involves continuous EEG monitoring, real-time seizure prediction, and alert notifications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (≥18 years) with a confirmed epilepsy diagnosis by a neurologist or epilepsy specialist.
- History of active seizures within the last year, under stable treatment (medications, VNS, diet, or surgery) for at least 3 months.
- Capacity to provide informed consent (or via legal representative if cognitively impaired).
- Willingness to participate and sign consent.
- Residents of Oman attending Khoula Hospital or affiliated clinics.
Key exclusion criteria (9 listed)
- Seizures from non-epileptic causes (e.g., psychogenic, metabolic, tumors).
- Under 18 years of age.
- Severe cognitive impairment preventing consent or protocol adherence.
- Pregnant or planning pregnancy during the study.
- Severe uncontrolled medical conditions (e.g., heart disease, cancer).
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 |
|---|---|---|
| Wearable seizure prediction and alert glassesAlso: NEXA glasses, wearable EEG glasses, neuromorphic seizure prediction deviceA glasses-based wearable EEG system using the international 10-20 electrode placement standard with 4 dry spiked electrodes at F7, F8, T3 and T4. The device integrates neuromorphic computing for real-time seizure prediction, an artifact removal algorithm, and multi-modal alerts (vibration, light, sound). Data is logged for model improvement. The system is intended for continuous use in both hospital-monitored and daily-life settings. | Device | Elderly adults, Young adults, middle-aged adults |
Primary outcome
Accurate Seizure Detection in Real-World Patient Settings
Time frame: From start of patient data collection until end of clinical trial (estimated 3 months).
Measure the ability of the NEXA wearable EEG glasses to detect epileptic seizures in real-world patient settings with a target accuracy of ≥95%, using simultaneous hospital EEG recordings as the reference standard.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No. Sharing is on permission basis based on Omani Ministry of Health policies.
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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.
Said Al-Mawali, PhD principal investigator
Oman Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable seizure prediction and alert glasses in people with Epilepsy and Epileptic Seizures, run by Oman Ministry of Health at 1 site in Oman.
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 7 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 7 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 Oman. 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?
This study is still under way. Results are not available in the source record yet.
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?
Accurate Seizure Detection in Real-World Patient Settings (time frame: From start of patient data collection until end of clinical trial (estimated 3 months).). 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 7 Oct 2025.