Cybersickness in Different Multisensory Conditions in Virtual Reality

NCT ID: NCT05534880

Last Updated: 2023-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2023-07-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cybersickness Reduced Sensation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study will be a double-blind randomized controlled clinical trial, with university students of both sexes in the city of Parnaíba - PI, volunteers who present cybersickness will be evaluated, those who meet the admission criteria will be randomized and allocated and will be immersed in three conditions, in these conditions the volunteers will be immersed in VR to induce symptoms, where bimodal conditions will be analyzed and compared to analyze the variable electrophysiological activity and the influence of multisensory conditions.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Participants will not be aware of the intention of each of the immersion conditions, and will be randomized through a program for each of the conditions, by a researcher external to the research, and sorted through an opaque envelope, the participants and the researcher, not will know in which condition they will be allocated, only on the day of the draw, each participant will be allocated in the condition and the researcher will not be aware of which condition the participant will be immersed in (condition 01 - video only) or (condition 02 - video associated with binaural beat) .

Study Groups

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Virtual Reality

Condition 01 - the participants will be induced to CS, they will be immersed in a roller coaster simulation video, lasting 10 minutes, there will be 03 sessions on alternate days with a 24-hour interval between each session, before and after each session will be applied the SSQ questionnaire subjective assessment and EEG objective assessment.

Group Type ACTIVE_COMPARATOR

Binaural beats

Intervention Type 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.

Virtual reality and binaural beats

Condition 02 - the participants will be induced to CS, they will be immersed in a roller coaster simulation video associated with audio with binaural beat, lasting 10 minutes, there will be 03 sessions on alternate days with a 24-hour interval between each session, before and after each session, the SSQ subjective assessment questionnaire and the objective assessment EEG will be applied.

Group Type EXPERIMENTAL

Binaural beats

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Piaui

OTHER

Sponsor Role lead

Responsible Party

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Marcos Junio da Costa Silva

Undegraduate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victor H. Bastos, Ph. D

Role: PRINCIPAL_INVESTIGATOR

Federal University of the Parnaiba Delta

Locations

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Federal University of the Delta Parnaíba

Parnaíba, Piauí, Brazil

Site Status

Federal University of the Parnaiba Delta

Parnaíba, Piauí, Brazil

Site Status

Countries

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Brazil

Related Links

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https://pubmed.ncbi.nlm.nih.gov/27075537/

Dissociating vestibular and somatosensory contributions to spatial orientation

https://pubmed.ncbi.nlm.nih.gov/32906122/

The Potential of Immersive Virtual Reality for Cognitive Training in Elderly

https://pubmed.ncbi.nlm.nih.gov/29187819/

A Failure to Enhance EEG Power and Emotional Arousal

https://pubmed.ncbi.nlm.nih.gov/28592282/

The role of virtual reality in improving motor performance as revealed by EEG: a randomized clinical trial

https://pubmed.ncbi.nlm.nih.gov/28592282/

Humans integrate visual and haptic information in a statistically optimal fashion

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7204407/

The Effects of Binaural and Monoaural Beat Stimulation on Cognitive Functioning in Subjects with Different Levels of Emotionality

https://pubmed.ncbi.nlm.nih.gov/26595956/

Vestibular-somatosensory interactions: A mechanism in search of a function?

https://pubmed.ncbi.nlm.nih.gov/32256856/

Too Real to Be Virtual: Autonomic and EEG Responses to Extreme Stress Scenarios in Virtual Reality

https://pubmed.ncbi.nlm.nih.gov/30073406/

Efficacy of binaural auditory beats in cognition, anxiety, and pain perception: a meta-analysis

https://brill.com/view/journals/msr/29/6-7/article-p525_2.xml

Multisensory integration in self motion perception. Multisensory Research

https://pubmed.ncbi.nlm.nih.gov/31264611/

Cybersickness: A multisensory integration perspective

https://pubmed.ncbi.nlm.nih.gov/31233640/

Vection in virtual reality modulates vestibular-evoked myogenic potentials

https://pubmed.ncbi.nlm.nih.gov/7352918/

Binaural interaction of a beating frequency following response

https://link.springer.com/article/10.1007/s10055-021-00524-3

A meta-analysis of the virtual reality problem: Unequal effects of virtual reality sickness across individual differences

Other Identifiers

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UFDPar

Identifier Type: -

Identifier Source: org_study_id

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