Development of Consciousness Measure and Monitor Device Based on Electroencephalography

NCT04952090 | Unknown DMC

• 1 other identifier: SNUEMS_HUMAN_EEG
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop a consciousness measuring and monitoring device using a single-channel electroencephalogram (EEG).

Conditions

Electroencephalography; Consciousness

Outcome Measures

Primary Outcomes (1)

• Consciousness level using the Glasgow Coma Scale (GCS) scale.

  The GCS score ranges from 15 to 3 points, with a higher score indicating an alert consciousness and a lower score indicating decreased consciousness. A binary outcome of GCS\<=8 and GCS\>8 will be used in this study.

  At the time of study completion (May 31, 2023, anticipated).

Secondary Outcomes (1)

• Consciousness level using the AVPU (Alert; Verbal; Pain; Unresponsive) scale.

  At the time of study completion (May 31, 2023, anticipated).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a decreased level of consciousness who have visited the study hospital EDs and have stayed at the ED for less than 12 hours at the time of enrollment will be included.

You may qualify if:

• Adult ED patients with a decreased level of consciousness (verbal, pain, or unresponsive using the AVPU scale, and a GCS-E score of less than 4) who have stayed at the ED for less than 12 hours at the time of enrollment.

You may not qualify if:

• Patients with the difficulty of applying EEG due to head trauma or skull deformities.
• Patients for whom standard treatment may be significantly delayed by applying the EEG device.
• Patients with a guardian who do not agree to enroll in this study.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Study Officials

• Ki Hong Kim

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Hyun Choi

CONTACT

+82-2-2072-4052; donghyun369@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: July 7, 2021
• Study Start: July 28, 2020
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

KR (1)