跳至主要内容
临床试验/NCT05534880
NCT05534880已完成不适用

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

Federal University of Piaui4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
4
主要终点
analysis of electrophysiological activity

研究概览

简要总结

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.

详细描述

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;

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

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) .

入排标准

年龄范围
18 Years 至 28 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must have normal or corrected to normal vision
  • Participant must have a history of visually induced motion sickness

排除标准

  • Cannot present vestibular disorders
  • Claustrophobia
  • Epileptic seizures
  • Musculoskeletal disorders
  • psychoactive drug use
  • Neurological disorders
  • Considerable hearing loss

结局指标

主要结局

analysis of electrophysiological activity

时间窗: 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.

次要结局

  • Analysis of symptoms through the SSQ questionnaire(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)

研究者

发起方
Federal University of Piaui
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcos Junio da Costa Silva

Undegraduate

Federal University of Piaui

研究点 (4)

Loading locations...

相似试验