ElectroencephalographyNCT04952090
Development of Consciousness Measure and Monitor Device Based on Electroencephalography
An observational study of Electroencephalography and Consciousness, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to develop a consciousness measuring and monitoring device using a single-channel electroencephalogram (EEG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electroencephalography, Consciousness
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jul 2020to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Ki Hong Kim, +82-2-2072-4052, emphysiciankkh@gmail.com
About this study
Official title: Development of Consciousness Measure and Monitor Device Based on Quantitative Electroencephalography Analysis In Emergency Patient
This study aims to develop a consciousness measuring and monitoring device using a single-channel electroencephalogram (EEG).
Read the detailed description
Study objectives:
- To develop a single-channel EEG database of emergency department (ED) patients with altered mental status.
- To analyze single-channel EEG recordings and extract significant parameters.
- To develop a consciousness prediction model using single-channel EEG.
Study design: observational multicenter study in 6 tertiary hospital EDs in Korea (Seoul National University Hospital, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Kyungpook National University Hospital, Chungbuk National University Hospital, Chonnam National University Hospital, Korea University Ansan Hospital).
The investigators will obtain single-channel EEG data of ED patients with altered consciousness and develop a prospective database of the data.
With the constructed database, a consciousness prediction model using single-channel EEG will be developed.
The prediction performance of the developed model using area under receiver operating characteristic curve (AUC) will be evaluated.
- Conditions
- Electroencephalography, Consciousness
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of study completion (May 31, 2023, anticipated).
Secondary outcomes (1)
Consciousness level using the AVPU (Alert; Verbal; Pain; Unresponsive) scale.
A multi-class outcome (A: alert, V: verbal, P: pain, U: unresponsive) will be used in this study.
Measured: At the time of study completion (May 31, 2023, anticipated).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start28 Jul 2020
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroencephalographyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Sponsor
- Investigators
- Ki Hong Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952090
- Sponsor's protocol ID
- SNUEMS_HUMAN_EEG
- Status last verified
- Apr 2023
- First submitted
- 20 Jun 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Consciousness Measure and Monitor Device Based on Quantitative Electroencephalography Analysis In Emergency Patient
- ClinicalTrials.gov ID
- NCT04952090
- Acronym / sponsor ID
- SNUEMS_HUMAN_EEG
- Conditions
- Electroencephalography, Consciousness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop a consciousness measuring and monitoring device using a single-channel electroencephalogram (EEG).
Detailed description
Study objectives:
- To develop a single-channel EEG database of emergency department (ED) patients with altered mental status.
- To analyze single-channel EEG recordings and extract significant parameters.
- To develop a consciousness prediction model using single-channel EEG.
Study design: observational multicenter study in 6 tertiary hospital EDs in Korea (Seoul National University Hospital, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Kyungpook National University Hospital, Chungbuk National University Hospital, Chonnam National University Hospital, Korea University Ansan Hospital).
The investigators will obtain single-channel EEG data of ED patients with altered consciousness and develop a prospective database of the data.
With the constructed database, a consciousness prediction model using single-channel EEG will be developed.
The prediction performance of the developed model using area under receiver operating characteristic curve (AUC) will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Consciousness level using the Glasgow Coma Scale (GCS) scale.
Time frame: At the time of study completion (May 31, 2023, anticipated).
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.
1 secondary outcome
Consciousness level using the AVPU (Alert; Verbal; Pain; Unresponsive) scale.
Time frame: At the time of study completion (May 31, 2023, anticipated).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Hong Kim principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electroencephalography and Consciousness, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Hyun Choi (+82-2-2072-4052, donghyun369@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consciousness level using the Glasgow Coma Scale (GCS) scale. (time frame: At the time of study completion (May 31, 2023, anticipated).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.