A novel wearable system for monitoring and alerting for seizures and cardiorespiratory dysfunctions

M
Makram Obeid

Primary Investigator

Enrolling By Invitation
6 years or above
All
Phase N/A
10 participants needed
2 Locations

Brief description of study

What is this study about?
The purpose of this study is to learn more about Neurava’s Wearable Devices (arm wearable, neck wearable, and smartphone app). The Neurava device is used to monitor and alert seizures and problems concerning the heart and/or lungs on people with epilepsy. The wearable devices do not provide any therapy or require intervention. 
 
THIS STUDY IS ENROLLING BY INVITATION ONLY -  Individuals who are scheduled for a visit to the Epilepsy Monitoring Unit (EMU) will be identified by the clinical team and referred to the study team to be invited to participate. Study staff will approach referred individuals about the study opportunity prior to EMU scheduled visit or at the time of admission to the EMU. Participants may be approached in person, by phone, or by email if the participant’s family expresses interest by email.

Detailed description of study

What will happen during the 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
  • Age: 6 years or above
  • 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.
 

Updated on 29 Apr 2025. Study ID: NEUR-NEURAVA-DEVICE, 21034
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting referrals by invitation only