NCT06368999

Brief Summary

The goal of this observational study is to compare in participant population the effect of stress condition on cerebral EEG activity Participants will do an 8 minutes EEG registration. Researchers will compare EEG activity of heathcare workers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2021

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
Last Updated

April 16, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

March 29, 2024

Last Update Submit

April 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • EEG activity

    The subjects were instrumented with 19 bridge silver and silver chloride electrodes fitted on a plastic prewired head cap and placed on the scalp according to the 10-20 system (namely: Fp1, Fp2, F3, F4, F7, F8, Fz, C3, C4, Cz, P3, P4, Pz, T3, T4, T5, T6, O1, and O2), with an electroconductive paste applied between the electrodes and the skin to guarantee optimal connection The signals were recorded with a 512 Hz sampling frequency and filtered by an offline first order zero-phase Butterworth band-pass filter, with cutoff frequencies set, respectively, at 1.6 and 70 Hz to remove frequencies outside the range of interest. After this pre-processing, the main EEG rhythms and dominant frequencies were extracted by spectral and connectivity analyses. Delta (1.6-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), gamma1 (30-50 Hz), and gamma2 (50-70 Hz) frequency bands were considered.

    immediately after the outbreak of the pandemic (first session) and almost 6 months later (second session).

Study Arms (1)

heatlhcare workers

EXPERIMENTAL
Diagnostic Test: EEG

Interventions

EEGDIAGNOSTIC_TEST

registration of 8 minutes of EEG

heatlhcare workers

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthcare workers

You may not qualify if:

  • neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: study of brain EEG activity
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2024

First Posted

April 16, 2024

Study Start

May 27, 2020

Primary Completion

December 21, 2020

Study Completion

January 9, 2021

Last Updated

April 16, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations