3WAVeS: Three-Axis Wearable Adaptive Vestibular Stimulator
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- COG Sway velocity
研究概览
简要总结
The purpose of this study is to improve current galvanic vestibular stimulation (GVS) technology to ease the motion sickness often associated with virtual reality (VR) simulation.
详细描述
The Three-Axis Wearable Adaptive Vestibular Stimulator (3WAVeS) technology that combines galvanic vestibular stimulation (GVS) and Virtual Reality (VR) will not only increase VR-based simulation realism and presence, but will also mitigate the motion sickness often associated with VR simulation by re-coupling the vestibular and ocular inputs to the VR user. Additionally, due to GVS technology's ability to accurately provide continuous inputs to the vestibular system, 3WAVeS can intentionally simulate high-fidelity effects of spatial disorientation for training purposes.
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
- Single (Participant)
盲法说明
Participants will be blinded to the galvanic stimulation (GVS) intervention.
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For our purposes, participants must be able to consent to participate themselves and be 21 to 55 years of age
- •Must be able to attend in-person sessions at the Mayo Aerospace Medicine and Vestibular Research Laboratory in Scottsdale, AZ.
- •No racial/ethnic groups will be excluded, although all participants must be fluent speakers of English.
排除标准
- •- History of vestibular disease, migraine, or significant balance disorder; history of severe motion sensitivity, women who are pregnant.
研究组 & 干预措施
Negative GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system
Subjects will receive negative galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system.
干预措施: Galvanic Vestibular Stimulation (GVS) (Device)
Positive GVS During VR Flight Simulation
Subjects will receive positive galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR).
干预措施: Galvanic Vestibular Stimulation (GVS) (Device)
Positive GVS During VR Flight Simulation
Subjects will receive positive galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR).
干预措施: Flight simulations in virtual reality (VR) (Other)
Negative GVS During VR Flight Simulation
Subjects will receive negative galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR).
干预措施: Galvanic Vestibular Stimulation (GVS) (Device)
Negative GVS During VR Flight Simulation
Subjects will receive negative galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR).
干预措施: Flight simulations in virtual reality (VR) (Other)
No GVS During VR Flight Simulation
Subjects will not receive any galvanic vestibular stimulation (GVS) during a flight simulation in virtual reality (VR).
干预措施: Flight simulations in virtual reality (VR) (Other)
Positive GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system
Subjects will receive positive galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system.
干预措施: Galvanic Vestibular Stimulation (GVS) (Device)
Positive GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system
Subjects will receive positive galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system.
干预措施: 3-DOF Bertec Portable Essential's dual-balance force plate system (Other)
Negative GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system
Subjects will receive negative galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system.
干预措施: 3-DOF Bertec Portable Essential's dual-balance force plate system (Other)
No GVS During 3-DOF Bertec Portable Essential's dual-balance force plate system
Subjects will not receive any galvanic vestibular stimulation (GVS) while utilizing the 3-DOF Bertec Portable Essential's dual-balance force plate system.
干预措施: 3-DOF Bertec Portable Essential's dual-balance force plate system (Other)
结局指标
主要结局
COG Sway velocity
时间窗: Immediately after balance testing in each session, approximately 1 hour
The sway angle of the center of gravity (COG) is the measure the amount of sway in any direction. The COG sway velocity is the ratio of the distance traveled by the COG (degrees) to the time (sec) of the trial.
Pensacola Diagnostic Index-based motion sickness questionnaire
时间窗: Immediately after each flight stimulation session, approximately 1 hour
This index allowed a comparison of motion sickness severity across subjects that may each present with a different constellation of symptoms like nausea, skin color, sweating, salivation, drowsiness, headache, and dizziness. The approach is to have the subject and/or observer grade the subjective intensity of different modalities of symptoms and signs (described below) as slight, moderate or severe. Overall motion sickness severity is then derived from a sum of scores resulting in a weighted "malaise index".
次要结局
未报告次要终点
研究者
Gaurav N. Pradhan
Principal Investigator
Mayo Clinic