Clinical trial NCT06701708: Exploratory Study on Artifact Denoising of Cerebral Blood Flow and EEG Data in Ambulance Settings
Official title: Exploratory Study on Artifact Denoising of Cerebral Blood Flow and EEG Data in Ambulance Settings
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Normal
EEG
FNIRS
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal individual

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Electroencephalography (EEG) signals in the ambulance
timeFrame: 10 minutes by boarding an ambulance in driving
Secondary outcomes:
measure: Functional Near-Infrared Spectroscopy(fNIRS) signals in the ambulance
timeFrame: 10 minutes by boarding an ambulance in driving
Other outcomes:
Locations:
Study officials:
References: