An interventional study of Binaural beats in Cybersickness and Reduced Sensation, sponsored by Federal University of Piaui. Completed at 2 sites in Brazil. Open to participants aged 18 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-08.
Sponsored by Federal University of Piaui · Not applicable, Interventional, and Treatment
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.
Objectives
General Objective
Specific Objectives
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.
47 studies on the registry are indexed under Hypesthesia; 12 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 43 interventional studies indexed under Hypesthesia.
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Exclusion Criteria:
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 - 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.
analysis of electrophysiological activity
Analisys of absolute power of the Delta band frequencies of the frontal and temporand 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
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').
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
Plan to share: No
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Federal University of Piaui