CybersicknessNCT05534880
Cybersickness in Different Multisensory Conditions in Virtual Reality
A study testing Binaural beats in people with Cybersickness and Reduced Sensation, run by Federal University of Piaui at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Cybersickness, Reduced Sensation
- What is being tested?
- Binaural beats
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesBrazil
- Study dates
- 8 Nov 2022to 9 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must have normal or corrected to normal vision
- Participant must have a history of visually induced motion sickness
Who cannot join
- Cannot present vestibular disorders
- Claustrophobia
- Epileptic seizures
- Musculoskeletal disorders
- psychoactive drug use
- Neurological disorders
- Considerable hearing loss
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Federal University of the Delta Parnaíba
Parnaíba, Piauí, 64202-020
Federal University of the Parnaiba Delta
Parnaíba, Piauí, 64202-020
About this study
Official title: 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.
Read the 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.
- Conditions
- Cybersickness, Reduced Sensation
- Being tested
- Binaural beats
- Keywords
- cybersickness, virtual reality, binaural beats, electroencephalography
- Medical subject headings
- Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural beatsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Active comparator | 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. Receives: Other: Binaural beats |
| Virtual reality and binaural beats | Experimental | 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. Receives: Other: Binaural beats |
What is being measured
The primary outcome is the main question the study is designed to answer.
analysis of electrophysiological activity
Analisys of absolute power of the Delta band frequencies of the frontal and temporand regions of the brain.
Measured: In pre-intervention procedures, the baseline cortical electroencephalography will be analyzed for 5 minutes. After immersion, the same procedures will be performed
Secondary outcomes (1)
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').
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start8 Nov 2022
- Primary completion10 May 2023
- Study completion9 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CybersicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Piaui
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcos Junio da Costa Silva, Federal University of Piaui
- Investigators
- Victor H. Bastos, Ph. D, Principal investigator, Federal University of the Parnaiba Delta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534880
- Sponsor's protocol ID
- UFDPar
- Status last verified
- Nov 2023
- First submitted
- 4 Sep 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Cortical Activity in Individuals With Cybersickness Under the Influence of Multi-sensory Conditions in Virtual Reality: a Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT05534880
- Acronym / sponsor ID
- UFDPar
- Conditions
- Cybersickness, Reduced Sensation
- Keywords
- cybersickness, virtual reality, binaural beats, electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Federal University of PiauiUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 9 Jul 2023 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Active comparator | Other: Binaural beatsCondition 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. |
| Virtual reality and binaural beats | Experimental | Other: Binaural beatsCondition 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. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must have normal or corrected to normal vision
- Participant must have a history of visually induced motion sickness
Key exclusion criteria (7 listed)
- Cannot present vestibular disorders
- Claustrophobia
- Epileptic seizures
- Musculoskeletal disorders
- psychoactive drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binaural beatsCondition 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. | Other | Virtual Reality, Virtual reality and binaural beats |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Dissociating vestibular and somatosensory contributions to spatial orientationLink provided by the sponsor.
- The Potential of Immersive Virtual Reality for Cognitive Training in ElderlyLink provided by the sponsor.
- Simulator Sickness Questionnaire: tradução e adaptação transculturalLink provided by the sponsor.
- A Failure to Enhance EEG Power and Emotional ArousalLink provided by the sponsor.
- The role of virtual reality in improving motor performance as revealed by EEG: a randomized clinical trialLink provided by the sponsor.
- Humans integrate visual and haptic information in a statistically optimal fashionLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cybersickness
Recruiting
Cybersickness Prevention and Mitigation in Virtual Reality for Healthy Volunteers
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RecruitingObservational study
Turkish Adaptation of the CSQ-VR
Healthy Volunteers
Not yet recruiting
Single Arm, Monocentric, Pilot Feasibility Study on an Interactive Virtual Reality Program in 20 Complex In-clinic Palliative Care Patients
Palliative Care, Refractory Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor H. Bastos, Ph. D principal investigator
Federal University of the Parnaiba Delta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binaural beats in people with Cybersickness and Reduced Sensation, run by Federal University of Piaui at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.