NCT05184686

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

April 23, 2024

Status Verified

December 1, 2021

Enrollment Period

11 months

First QC Date

December 22, 2021

Last Update Submit

April 22, 2024

Conditions

Keywords

ElectroencephalographyNoise Exposureelectromagnetic Exposure

Outcome Measures

Primary Outcomes (2)

  • alpha band power of the EEG spectral

    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

    Procedure (record EEG during the noise and RF expose, and then compute theta/beta of the EEG )

Study Arms (4)

noise(low-level) and RF(low-level)

ACTIVE COMPARATOR
Other: noise exposeOther: RF expose

noise(high-level) and RF(low-level)

ACTIVE COMPARATOR
Other: noise exposeOther: RF expose

noise(high-level) and RF(high-level)

ACTIVE COMPARATOR
Other: noise exposeOther: RF expose

noise(low-level) and RF(high-level)

ACTIVE COMPARATOR
Other: noise exposeOther: RF expose

Interventions

simulate noise expose environments

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)

simulate RF expose environments

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)

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male, 18-30 years old, right-handed, with normal hearing and normal visual or corrected acuity;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Air Force Military Medical University

Xi’an, Shanxi, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 11, 2022

Study Start

November 6, 2021

Primary Completion

October 15, 2022

Study Completion

November 15, 2023

Last Updated

April 23, 2024

Record last verified: 2021-12

Locations