NormalNCT06701708
Exploratory Study on Artifact Denoising of Cerebral Blood Flow and EEG Data in Ambulance Settings
An observational study of Normal and EEG, run by Pusan National University Yangsan Hospital.
Trial summary
The purpose is to assess the extent of digital noise occurring during the measurement of cerebral blood flow and EEG in healthy adults within an ambulance setting and to explore the possibility of identifying and correcting abnormal patterns. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Participants are not assigned to interventions based on a protocol.
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal individual
Who may be able to join
- Healthy adults aged 19 to 80 years.
- Individuals without chronic diseases (e.g., Stage 2 hypertension, cardiovascular disease, chronic kidney disease, chronic pulmonary disease, etc.).
- Individuals without mental health disorders (e.g., depression, schizophrenia, etc.).
- Individuals not taking medications that could affect cerebral hemodynamics, such as antihypertensives, anticoagulants, antiplatelets, antidepressants, etc.
- Individuals who can read and understand the participant information and consent form and have sufficient language ability to respond to questionnaires.
- Individuals who voluntarily decide to participate in the clinical study, provide written consent on the participant consent form, and are able to participate throughout the entire duration of the clinical study.
Who cannot join
- Individuals who have experienced head trauma in the past 6 months.
- Individuals with ongoing severe chronic diseases (e.g., heart failure, chronic kidney disease, chronic pulmonary disease, etc.).
- Individuals with severe mental health disorders such as schizophrenia, severe depression, bipolar disorder, etc.
- Individuals currently taking medications that may affect the study (e.g., antihypertensives, anticoagulants, antiplatelets, antidepressants, etc.).
- Individuals who have participated in a clinical trial and taken experimental drugs within the past 30 days.
- Women who are pregnant or breastfeeding.
Show all 12Show fewer
- Individuals who have undergone major surgery in the past 6 months.
- Individuals with acute infections or inflammatory diseases.
- Individuals with cognitive impairment or dementia.
- Individuals with neurological disorders.
- Individuals who lack understanding of the study procedures or who have not voluntarily consented to participate.
- Individuals with clinically significant findings that the study principal investigator or responsible medical personnel determines to be inappropriate for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose is to assess the extent of digital noise occurring during the measurement of cerebral blood flow and EEG in healthy adults within an ambulance setting and to explore the possibility of identifying and correcting abnormal patterns.
- Being tested
- Participants are not assigned to interventions based on a protocol.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants are not assigned to interventions based on a protocol.Other
Participants are not assigned to interventions based on a protocol.
| Study group | Role | What they receive |
|---|---|---|
| Normal | Not described Receives: Other: Participants are not assigned to interventions based on a protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography (EEG) signals in the ambulance
Electroencephalography (EEG) is used for measurement. Electroencephalography (EEG) is a non-invasive technique used to record the electrical activity of the brain through electrodes placed on the scalp. These electrodes detect and amplify signals generated by the synchronous activity of neurons, particularly in the cerebral cortex. EEG provides a real-time measure of brain activity with high temporal resolution, typically capturing signals in the range of 1-100 Hz.
Measured: 10 minutes by boarding an ambulance in driving
Secondary outcomes (1)
Functional Near-Infrared Spectroscopy(fNIRS) signals in the ambulance
Functional Near-Infrared Spectroscopy (fNIRS) is a non-invasive optical imaging technique used to measure changes in brain activity by detecting hemodynamic responses associated with neural activity. It relies on the absorption properties of near-infrared light, which penetrates the scalp and skull to assess oxygenated (HbO) and deoxygenated (HbR) hemoglobin levels in cortical regions.
Measured: 10 minutes by boarding an ambulance in driving
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NormalStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701708
- Sponsor's protocol ID
- 11-2024-058
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on Artifact Denoising of Cerebral Blood Flow and EEG Data in Ambulance Settings
- ClinicalTrials.gov ID
- NCT06701708
- Acronym / sponsor ID
- 11-2024-058
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Nov 2024 (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.
The purpose is to assess the extent of digital noise occurring during the measurement of cerebral blood flow and EEG in healthy adults within an ambulance setting and to explore the possibility of identifying and correcting abnormal patterns.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Other: Participants are not assigned to interventions based on a protocol. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal individual
Key inclusion criteria (6 listed)
- Healthy adults aged 19 to 80 years.
- Individuals without chronic diseases (e.g., Stage 2 hypertension, cardiovascular disease, chronic kidney disease, chronic pulmonary disease, etc.).
- Individuals without mental health disorders (e.g., depression, schizophrenia, etc.).
- Individuals not taking medications that could affect cerebral hemodynamics, such as antihypertensives, anticoagulants, antiplatelets, antidepressants, etc.
- Individuals who can read and understand the participant information and consent form and have sufficient language ability to respond to questionnaires.
Key exclusion criteria (12 listed)
- Individuals who have experienced head trauma in the past 6 months.
- Individuals with ongoing severe chronic diseases (e.g., heart failure, chronic kidney disease, chronic pulmonary disease, etc.).
- Individuals with severe mental health disorders such as schizophrenia, severe depression, bipolar disorder, etc.
- Individuals currently taking medications that may affect the study (e.g., antihypertensives, anticoagulants, antiplatelets, antidepressants, etc.).
- Individuals who have participated in a clinical trial and taken experimental drugs within the past 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants are not assigned to interventions based on a protocol.Participants are not assigned to interventions based on a protocol. | Other | Normal |
Primary outcome
Electroencephalography (EEG) signals in the ambulance
Time frame: 10 minutes by boarding an ambulance in driving
Electroencephalography (EEG) is used for measurement. Electroencephalography (EEG) is a non-invasive technique used to record the electrical activity of the brain through electrodes placed on the scalp. These electrodes detect and amplify signals generated by the synchronous activity of neurons, particularly in the cerebral cortex. EEG provides a real-time measure of brain activity with high temporal resolution, typically capturing signals in the range of 1-100 Hz.
1 secondary outcome
Functional Near-Infrared Spectroscopy(fNIRS) signals in the ambulance
Time frame: 10 minutes by boarding an ambulance in driving
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal and EEG, run by Pusan National University Yangsan Hospital.
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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youjin Jeong Youjin Jeong (082-055-360-4159, ctccrc@pnuyh.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography (EEG) signals in the ambulance (time frame: 10 minutes by boarding an ambulance in driving). 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 22 Nov 2024.