Cybersickness in Different Multisensory Conditions in Virtual Reality

November 7, 2023 updated by: Marcos Junio da Costa Silva, Federal University of Piaui

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Piauí
      • Parnaíba, Piauí, Brazil, 64202-020
        • Federal University of the Delta Parnaíba
      • Parnaíba, Piauí, Brazil, 64202-020
        • Federal University of the Parnaiba Delta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 28 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
In pre-intervention procedures, the baseline cortical electroencephalography will be analyzed for 5 minutes. After immersion, the same procedures will be performed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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').
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Piaui

Investigators

  • Principal Investigator: Victor H. Bastos, Ph. D, Federal University of the Parnaiba Delta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2022

Primary Completion (Actual)

May 10, 2023

Study Completion (Actual)

July 9, 2023

Study Registration Dates

First Submitted

September 4, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFDPar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cybersickness

Clinical Trials on Binaural beats

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe