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Cybersickness in Different Multisensory Conditions in Virtual Reality

Primary Purpose

Cybersickness, Reduced Sensation

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Binaural beats
Sponsored by
Federal University of Piaui
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cybersickness focused on measuring cybersickness, virtual reality, binaural beats, electroencephalography

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Federal University of the Delta Parnaíba
  • Federal University of the Parnaiba Delta

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Virtual Reality

Virtual reality and binaural beats

Arm Description

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 05 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.

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 05 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.

Outcomes

Primary Outcome Measures

analysis of electrophysiological activity
Analisys of absolute power of the alpha, delta and theta band frequencies of the frontal, parietal, temporal and occipital regions of the brain.

Secondary Outcome Measures

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').

Full Information

First Posted
September 4, 2022
Last Updated
July 9, 2023
Sponsor
Federal University of Piaui
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1. Study Identification

Unique Protocol Identification Number
NCT05534880
Brief Title
Cybersickness in Different Multisensory Conditions in Virtual Reality
Official Title
Analysis of Cortical Activity in Individuals With Cybersickness Under the Influence of Multi-sensory Conditions in Virtual Reality: a Randomized Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
July 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Piaui

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 (EEGq) 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= 42 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, and after the last intervention, there will be a 7-day follow-up and reassessment with qEEG and SSQ. 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
OBJECTIVES General: To analyze whether the cortical activity of individuals with cybersickness is influenced by different multisensory conditions in virtual reality. Specific: To correlate if the oscillations of the absolute power of the alpha, delta and theta band frequencies of the frontal, parietal and occipital regions of the brain of individuals with cybersickness are influenced by different multisensory conditions; Check for differences in cortical activity between different conditions: visual only (VR) and visual binaural (VR+BB); To compare whether binaural beat induction can modulate cortical brain responses compared to the other conditions. ETHICAL ASPECTS: The study will be a randomized controlled double-blind 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. The study will be developed 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 Parnaíba, Piauí, Brazil. Patients who meet the inclusion criteria after the evaluation, if they agree with the experiment, will be informed about the procedures, will sign the Free and Informed Consent Term (ICF) after approval of the approval protocol by the Research Ethics Committee of the Federal University of Piaui. Everyone will be immersed in each of the conditions described. There will be the use of protective equipment from both parties, the evaluator with the proper use of gloves, masks, cap and lab coat, and the volunteer with the use of a mask. A minimum of 42 volunteers will be required, of both sexes, aged between 18 and 28 years, and they will not be able to present vestibulopathies, flu, claustrophobia and epilepsy, and musculoskeletal and neurological disorders. They will be instructed to abstain from the use of prescription drugs, alcoholic substances, and caffeinated beverages for at least 24 hours before each experiment. Sample To the satisfaction of the research, ANOVA with repeated measures, the sample size estimated a priori by power analysis, to detect the minimum clinically relevant difference between conditions, with an effect power of 0.5, alpha level of 0.05 two-tailed, statistical power of 80%. Starting with a primary outcome measure of 8% of the population of universities in Parnaíba, for the sample calculation there must be a total of 18 participants, assuming a dropout rate of 20%, the sample size of 20 participants in each condition is calculated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cybersickness, Reduced Sensation
Keywords
cybersickness, virtual reality, binaural beats, electroencephalography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
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) .
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Active Comparator
Arm Description
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 05 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.
Arm Title
Virtual reality and binaural beats
Arm Type
Experimental
Arm Description
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 05 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.
Intervention Type
Other
Intervention Name(s)
Binaural beats
Intervention Description
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 Outcome Measure Information:
Title
analysis of electrophysiological activity
Description
Analisys of absolute power of the alpha, delta and theta band frequencies of the frontal, parietal, temporal and occipital regions of the brain.
Time Frame
In pre-intervention procedures, the baseline cortical electroencephalography will be analyzed for 5 minutes. After immersion, the same procedures will be performed
Secondary Outcome Measure Information:
Title
Analysis of symptoms through the SSQ questionnaire
Description
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').
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor H. Bastos, Ph. D
Organizational Affiliation
Federal University of the Parnaiba Delta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of the Delta Parnaíba
City
Parnaíba
State/Province
Piauí
ZIP/Postal Code
64202-020
Country
Brazil
Facility Name
Federal University of the Parnaiba Delta
City
Parnaíba
State/Province
Piauí
ZIP/Postal Code
64202-020
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/27075537/
Description
Dissociating vestibular and somatosensory contributions to spatial orientation
URL
https://pubmed.ncbi.nlm.nih.gov/32906122/
Description
The Potential of Immersive Virtual Reality for Cognitive Training in Elderly
URL
https://www.scielo.br/j/jbpsiq/a/trfYrY8LfWzmpwh7Wqn9Cvr/?lang=pt#:~:text=O%20Simulator%20Sickness%20Questionnaire%20(SSQ,o%20n%C3%ADvel%20de%20cybersickness14.
Description
Simulator Sickness Questionnaire: tradução e adaptação transcultural
URL
https://pubmed.ncbi.nlm.nih.gov/29187819/
Description
A Failure to Enhance EEG Power and Emotional Arousal
URL
https://pubmed.ncbi.nlm.nih.gov/28592282/
Description
The role of virtual reality in improving motor performance as revealed by EEG: a randomized clinical trial
URL
https://pubmed.ncbi.nlm.nih.gov/28592282/
Description
Humans integrate visual and haptic information in a statistically optimal fashion
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7204407/
Description
The Effects of Binaural and Monoaural Beat Stimulation on Cognitive Functioning in Subjects with Different Levels of Emotionality
URL
https://pubmed.ncbi.nlm.nih.gov/26595956/
Description
Vestibular-somatosensory interactions: A mechanism in search of a function?
URL
https://pubmed.ncbi.nlm.nih.gov/32256856/
Description
Too Real to Be Virtual: Autonomic and EEG Responses to Extreme Stress Scenarios in Virtual Reality
URL
https://pubmed.ncbi.nlm.nih.gov/30073406/
Description
Efficacy of binaural auditory beats in cognition, anxiety, and pain perception: a meta-analysis
URL
https://brill.com/view/journals/msr/29/6-7/article-p525_2.xml
Description
Multisensory integration in self motion perception. Multisensory Research
URL
https://pubmed.ncbi.nlm.nih.gov/31264611/
Description
Cybersickness: A multisensory integration perspective
URL
https://pubmed.ncbi.nlm.nih.gov/31233640/
Description
Vection in virtual reality modulates vestibular-evoked myogenic potentials
URL
https://pubmed.ncbi.nlm.nih.gov/7352918/
Description
Binaural interaction of a beating frequency following response
URL
https://link.springer.com/article/10.1007/s10055-021-00524-3
Description
A meta-analysis of the virtual reality problem: Unequal effects of virtual reality sickness across individual differences
URL
https://pubmed.ncbi.nlm.nih.gov/22209784/
Description
Meta-analytical definition and functional connectivity of the human vestibular cortex

Learn more about this trial

Cybersickness in Different Multisensory Conditions in Virtual Reality

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