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OpenTrials
Completed

NCT Number: NCT05534880

Cybersickness in Different Multisensory Conditions in Virtual Reality

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.

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Key information

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of the Delta Parnaíba, Parnaíba, Piauí, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Binaural Beats

Other

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.

Primary outcomes

  1. analysis of electrophysiological activity

    Time frame: In pre-intervention procedures, the baseline cortical electroencephalography will be analyzed for 5 minutes. After immersion, the same procedures will be performed

    Analisys of absolute power of the Delta band frequencies of the frontal and temporand regions of the brain.

Secondary outcomes

  1. Analysis of symptoms through the SSQ questionnaire

    Time frame: 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

    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').

Sponsors and collaborators

Lead sponsor

Federal University of Piaui

Other

Registry information

Official study title

Analysis of Cortical Activity in Individuals With Cybersickness Under the Influence of Multi-sensory Conditions in Virtual Reality: a Randomized Crossover Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 10, 2022
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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