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OpenTrials
Completed

NCT Number: NCT04664608

Pediatric EEG Monitoring

The purpose of this study is to understand if a new, smart, wireless EEG developed by our team can be used to monitor the continuous electrical activity of the brain in the ICU and EMU and whether it works as well as the current standard, wired EEGs.

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Key information

About this study

The investigators propose to 1) optimize these devices for use in pediatric ICU patients, 2) demonstrate safety, reliability, and accuracy of these devices for continuous ICU EEG signal measurements, and 3) demonstrate these devices are preferred by patients and parents to current EEG devices. Once validated, such sensors could fundamentally change the way patients are monitored by EEG in the ICU, allowing wireless, continuous, real-time detection of brain wave activity in ICU patients, reducing limitations in mobility as well as access by staff and caregivers to the patient, and ultimately offering opportunity to reduce morbidity and mortality in ICU patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be admitted to the PICU or EMU at Lurie Children's and are prescribed an EEG as part of their standard of care.

Exclusion criteria

  • Anyone with a skin abnormality that would potentially increase the risk of device use will be excluded.
  • Ages 18 years or older.
  • Any patient or family determined by an attending physician or bedside care team to be too unstable (patient) or experiencing too much stress (family) will not be approached for recruitment.

Treatment and study plan

wearable EEG sensor

Device

Wireless wearable EEG devices offer a new, non-invasive, and easy way of performing EEG monitoring.

Primary outcomes

  1. Percent Agreement

    Time frame: 3 years

    Percent agreement between experimental sensor and commercially available electroencephalogram (EEG)

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Evaluation of a Wireless EEG Monitor for Pediatric Patients

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Dec 11, 2020
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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