- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05184686
Effects of Electromagnetic Field and Noise on Resting Electroencephalogram of Health Subjects
April 22, 2024 updated by: Xijing Hospital
Effects of Electromagnetic Field and Noise on Alpha Band and Functional Connections of Human Resting Electroencephalogram
With the development of science and technology, there are more and more electromagnetic and noise factors in the working and living environment.
These two factors often exist together, and their impact on people may interact.
Scalp EEG is a classic nerve detection technology, which can reflect the functional state of the brain in a non-invasive and real-time manner.
This project intends to use EEG technology to study the effects of electromagnetism and noise on human brain function.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanxi
-
Xi'an, Shanxi, China
- Air Force Military Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male, 18-30 years old, right-handed, with normal hearing and normal visual or corrected acuity;
Exclusion Criteria:
- Have history of smoking, alcohol abuse, no history of neurological or psychiatric disorders (e.g., epilepsy), no relevant family history, and no recent medication use;
- Have history of surgery for head injury, no metal implants in the body (including braces);
- Sleep-wake time irregular, with sleep disturbance;
- Have history of noise allergy;
- Participate in similar psychological experiments during 2 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: noise(low-level) and RF(low-level)
|
simulate noise expose environments
simulate RF expose environments
|
|
Active Comparator: noise(high-level) and RF(low-level)
|
simulate noise expose environments
simulate RF expose environments
|
|
Active Comparator: noise(high-level) and RF(high-level)
|
simulate noise expose environments
simulate RF expose environments
|
|
Active Comparator: noise(low-level) and RF(high-level)
|
simulate noise expose environments
simulate RF expose environments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
alpha band power of the EEG spectral
Time Frame: Procedure (record EEG during the noise and RF expose, and then compute the alpha band power of the EEG )
|
Procedure (record EEG during the noise and RF expose, and then compute the alpha band power of the EEG )
|
|
theta band power/beta band power of the EEG spectral
Time Frame: Procedure (record EEG during the noise and RF expose, and then compute theta/beta of the EEG )
|
Procedure (record EEG during the noise and RF expose, and then compute theta/beta of the EEG )
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 6, 2021
Primary Completion (Actual)
October 15, 2022
Study Completion (Actual)
November 15, 2023
Study Registration Dates
First Submitted
December 22, 2021
First Submitted That Met QC Criteria
January 7, 2022
First Posted (Actual)
January 11, 2022
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- KY20212098-F-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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