ElectroencephalographyNCT05184686
Effects of Electromagnetic Field and Noise on Resting Electroencephalogram of Health Subjects
A study testing noise expose and RF expose in people with Electroencephalography and Electromagnetic, run by Xijing Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Electroencephalography, Electromagnetic, Noise Exposure
- What is being tested?
- noise expose and RF expose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2021to 15 Nov 2023
- Phase
- Interventional
- 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 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, 18-30 years old, right-handed, with normal hearing and normal visual or corrected acuity;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Electroencephalography, Electromagnetic, Noise Exposure
- Being tested
- noise expose, RF expose
- Keywords
- Electroencephalography, Noise Exposure, electromagnetic Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noise exposeOther
simulate noise expose environments
RF exposeOther
simulate RF expose environments
| Study group | Role | What they receive |
|---|---|---|
| noise(low-level) and RF(low-level) | Active comparator | Not described Receives: Other: noise expose; Other: RF expose |
| noise(high-level) and RF(low-level) | Active comparator | Not described Receives: Other: noise expose; Other: RF expose |
| noise(high-level) and RF(high-level) | Active comparator | Not described Receives: Other: noise expose; Other: RF expose |
| noise(low-level) and RF(high-level) | Active comparator | Not described Receives: Other: noise expose; Other: RF expose |
What is being measured
The primary outcome is the main question the study is designed to answer.
alpha band power of the EEG spectral
Measured: 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
Measured: Procedure (record EEG during the noise and RF expose, and then compute theta/beta of the EEG )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start6 Nov 2021
- Primary completion15 Oct 2022
- Study completion15 Nov 2023
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 Xijing 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184686
- Sponsor's protocol ID
- KY20212098-F-1
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2021
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electromagnetic Field and Noise on Alpha Band and Functional Connections of Human Resting Electroencephalogram
- ClinicalTrials.gov ID
- NCT05184686
- Acronym / sponsor ID
- KY20212098-F-1
- Conditions
- Electroencephalography, Electromagnetic, Noise Exposure
- Keywords
- Electroencephalography, Noise Exposure, electromagnetic Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 6 Nov 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 11 Jan 2022 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| noise(low-level) and RF(low-level) | Active comparator | Other: noise expose, Other: RF expose |
| noise(high-level) and RF(low-level) | Active comparator | Other: noise expose, Other: RF expose |
| noise(high-level) and RF(high-level) | Active comparator | Other: noise expose, Other: RF expose |
| noise(low-level) and RF(high-level) | Active comparator | Other: noise expose, Other: RF expose |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male, 18-30 years old, right-handed, with normal hearing and normal visual or corrected acuity;
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| noise exposesimulate noise expose environments | Other | noise(high-level) and RF(high-level), noise(high-level) and RF(low-level), noise(low-level) and RF(high-level), noise(low-level) and RF(low-level) |
| RF exposesimulate RF expose environments | Other | noise(high-level) and RF(high-level), noise(high-level) and RF(low-level), noise(low-level) and RF(high-level), noise(low-level) and RF(low-level) |
Primary outcome
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 )
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 )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noise expose and RF expose in people with Electroencephalography and Electromagnetic, run by Xijing Hospital at 1 site in China.
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 5 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: finished, as of the sponsor's last update on 23 Apr 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 )). The study lists 2 primary outcomes in all. 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 23 Apr 2024.