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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05534880
Other study ID # UFDPar
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2022
Est. completion date July 9, 2023

Study information

Verified date November 2023
Source Federal University of Piaui
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cybersickness (CS) is characterized as a type of visually induced motion sickness, similar to traditional motion sickness, with specific clinical presentations such as dizziness, eyestrain, oculomotor disorders, blurred vision and spatial disorientation. It can be triggered when experiencing virtual reality (VR), and it affects approximately 20% to 80% of individuals who use these resources. Furthermore, the underlying mechanisms of CS are not fully understood and the use of virtual environments that have become increasingly recurrent in several sectors deserves attention, as VR is becoming commonplace in methods and techniques of assessment, diagnosis and treatment. Objective: to analyze cortical electrophysiological activity using electroencephalography (EEG) in individuals with SC, under the influence of different audiovisual conditions. Methodology: The study is a double-blind randomized controlled clinical trial, the sample for survey satisfaction N= 10 participants, the public were university students from the Universidade Federal do Delta Parnaíba (UFDPar) of both sexes, aged between 18 to 28 years, those who agreed, underwent screening, those who met the criteria and fit, were randomized and allocated to one each of 02 conditions, (C1 - video only) and (C2 - associated with binaural audio), three times in each condition, with a duration of 10 minutes of immersion, with evaluation (pre) before (post) with QEEG and Sickness Questionnaire (SSQ), exposure to virtual content was on regular alternate days, with a 24-hour interval between each virtual exposure, at the end of each condition, there will be a 14-day washout and crossover between the conditions. The study will be carried out under all cleaning and prevention care in the fight against the Covid-19 pandemic, data collection will be at the Brain Mapping and Functionality Laboratory (LAMCEF) of the Federal University of Delta do Parnaíba, Piauí, Brazil. Results: The condition with binaural stimulation is expected to promote neuromodulation and reduction of CS symptoms, compared to the control condition.


Description:

Objectives General Objective • Analyze whether the electrophysiological activity of the brain cortex of individuals with cybersickness undergoes neuromodulation through binaural stimuli; Specific Objectives - Investigate whether stimulation by binaural beats can mitigate the degree of symptoms through the SSQ; - Compare whether there is a significant reduction in Sickness Questionare Simulator scores between conditions; - Check if there is a difference in absolute power in the Delta band frequency of the parietal and frontal regions between the conditions; Hypothesis Our hypothesis is that the condition associated with binaural beats can promote neuromodulation in the electrophysiological activity of the brain cortex, altering the rhythms of brain wave frequencies, which can reduce sensory conflict in cybersickness, through wave entrainment.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date July 9, 2023
Est. primary completion date May 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 28 Years
Eligibility Inclusion Criteria: - Participants must have normal or corrected to normal vision - Participant must have a history of visually induced motion sickness Exclusion Criteria: - Cannot present vestibular disorders - Claustrophobia - Epileptic seizures - Musculoskeletal disorders - psychoactive drug use - Neurological disorders - Considerable hearing loss

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Binaural beats
Condition 02- will be used binaural beats, since they are referred through studies with the ability to drive neural oscillations in the beat frequency through differential hemispheric synchronization frequencies, it is expected that a neuromodulation and repercussion of the symptomatological reduction of CS.

Locations

Country Name City State
Brazil Federal University of the Delta Parnaíba Parnaíba Piauí
Brazil Federal University of the Parnaiba Delta Parnaíba Piauí

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Piaui

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary analysis of electrophysiological activity Analisys of absolute power of the Delta band frequencies of the frontal and temporand regions of the brain. In pre-intervention procedures, the baseline cortical electroencephalography will be analyzed for 5 minutes. After immersion, the same procedures will be performed
Secondary Analysis of symptoms through the SSQ questionnaire Simulator Sickness Questionnaire (SSQ) is a widely used tool to assess the subjective severity of symptoms of simulator illness and cybersickness. It consists of 16 items, on a four-point scale (from 'none' to 'severe'). In the pre-intervention procedures, before the cortical analysis, the SSQ instrument will be applied, and immediately after each session, the subjective assessment instrument will be applied
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