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| ID | Type | Description | Link |
|---|---|---|---|
| Khoula Hospital | Other Identifier | Oman MoH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable seizure prediction and alert glasses | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start of patient data collection until end of clinical trial (estimated 3 months). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Said Al-Mawali, PhD | Oman Ministry of Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khoula Hospital | Muscat | Oman |
Sharing is on permission basis based on Omani Ministry of Health policies.
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |