Clinical trial NCT05534880: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cybersickness
Reduced Sensation
Keywords: cybersickness
virtual reality
binaural beats
electroencephalography
Lead sponsor: Federal University of Piaui
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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 (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.

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

Primary outcomes:
measure: analysis of electrophysiological activity
timeFrame: In pre-intervention procedures, the baseline cortical electroencephalography will be analyzed for 5 minutes. After immersion, the same procedures will be performed
Secondary outcomes:
measure: Analysis of symptoms through the SSQ questionnaire
timeFrame: 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
Other outcomes:
Locations:
city: Parnaíba
country: Brazil
facility: Federal University of the Delta Parnaíba
state: Piauí
city: Parnaíba
country: Brazil
facility: Federal University of the Parnaiba Delta
state: Piauí
Study officials:
affiliation: Federal University of the Parnaiba Delta
name: Victor H. Bastos, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: