A novel wearable system for monitoring and alerting for seizures and cardiorespiratory dysfunctions
Makram Obeid
Primary Investigator
Brief description of study
Detailed description of study
Participants will be attached to two types of monitoring devices (in addition to typical video-EEG and EKG):
1. Recording of respiratory data through noninvasive sensors belts and transducers (i.e., nasal cannulas, respiratory belts, etc.) affixed on once enrolled in the study and adjusted daily as necessary. Data will be acquired continuously during the admission.
2. The devices developed by Neurava will be affixed to the upper arm and/or neck once enrolled in the study and adjusted and synced as necessary. Data will be acquired and recorded continuously during the EMU admission using a smartphone provided by Neurava. Only the study coordinator will need to interact with the smartphone and app – the patient will not need to interface with the app. Refer to Device Manual for more information on setup and use of Neurava’s full system.
These devices will be attached by the key study personnel. The patients will be assessed by the epilepsy/clinical neurophysiology fellow on daily basis during the EMU stay, which is standard patient care. Monitoring will continue during the entire length of the EMU admission. In parallel, a usability questionnaire (Patient Comfort Form) incorporating a 6-point Likert scale will be administered to each subject by the Key Study Personnel every other day including the beginning (end of day 1), and end of their EMU stay (last day). If the subject is younger than 10 years old or cognitively impaired, the subject’s caretaker or parent will fill out the Usability Questionnaire on behalf of the subject. If the subject is older than 10 years old and is not cognitively impaired, the subject will complete the Usability Questionnaire.
Given that the devices have not yet been approved by the FDA, clinically significant data may be shared with the clinical care team, but not directly with the participant.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Epilepsy, Seizure, Riley
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Age: 6 years or above
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Gender: All
Inclusion: Subjects ages 6 and up who are admitted to the Epilepsy Monitoring Unit (EMU) can be included in the study. Patients admitted for phase one evaluation must have a previously confirmed or be highly suspected of having epilepsy and a GTCS.
Exclusion: Patients implanted with a vagus nerve stimulator are excluded from the study. There are no other exclusion criteria.