Laryngoscope. 2011 Jan;121 Suppl 2(0 2):S17-35. doi: 10.1002/lary.21373.
OBJECTIVES/HYPOTHESES: An eyewear mounted visual display ("User-worn see-through display") projecting an artificial horizon aligned with the user's head and body position in space can prevent or lessen motion sickness in susceptible individuals when in a motion provocative environment as well as aid patients undergoing vestibular rehabilitation. In this project, a wearable display device, including software technology and hardware, was developed and a phase I feasibility study and phase II clinical trial for safety and efficacy were performed.
Both phase I and phase II were prospective studies funded by the NIH. The phase II study used repeated measures for motion intolerant subjects and a randomized control group (display device/no display device) pre-posttest design for patients in vestibular rehabilitation.
Following technology and display device development, 75 patients were evaluated by test and rating scales in the phase II study; 25 subjects with motion intolerance used the technology in the display device in provocative environments and completed subjective rating scales, whereas 50 patients were evaluated before and after vestibular rehabilitation (25 using the display device and 25 in a control group) using established test measures.
All patients with motion intolerance rated the technology as helpful for nine symptoms assessed, and 96% rated the display device as simple and easy to use. Duration of symptoms significantly decreased with use of the technology displayed. In patients undergoing vestibular rehabilitation, there were no significant differences in amount of change from pre- to posttherapy on objective balance tests between display device users and controls. However, those using the technology required significantly fewer rehabilitation sessions to achieve those outcomes than the control group.
A user-worn see-through display, utilizing a visual fixation target coupled with a stable artificial horizon and aligned with user movement, has demonstrated substantial benefit for individuals susceptible to motion intolerance and spatial disorientation and those undergoing vestibular rehabilitation. The technology developed has applications in any environment where motion sensitivity affects human performance.
目的/假设：一种佩戴在眼睛上的视觉显示器（“用户佩戴的透视显示器”），可将与用户在空间中的头部和身体位置对齐的人工地平线投影到用户眼前，当处于易引起运动的环境中时，它可以预防或减轻运动病，同时也可以帮助接受前庭康复的患者。在这个项目中，开发了一种可穿戴显示设备，包括软件技术和硬件，并进行了 I 期可行性研究和 II 期临床试验，以评估其安全性和有效性。
I 期和 II 期研究均为 NIH 资助的前瞻性研究。II 期研究对运动不耐受的受试者采用重复测量方法，并对前庭康复患者采用随机对照分组（显示设备/无显示设备）的前后测试设计。
在技术和显示设备开发之后，75 名患者在 II 期研究中接受了测试和评分量表评估；25 名运动不耐受的受试者在易引起运动的环境中使用该技术，并完成了主观评分量表，而 50 名前庭康复患者（25 名使用显示设备，25 名在对照组）使用已建立的测试措施进行了治疗前和治疗后的评估。
所有运动不耐受的患者都对该技术评估为有助于缓解九种症状，96%的患者认为显示设备简单易用。使用该技术后，症状的持续时间明显缩短。在接受前庭康复的患者中，使用显示设备的患者和对照组患者在治疗前后的客观平衡测试中，从治疗前到治疗后的变化量没有显著差异。然而，使用该技术的患者所需的康复治疗次数明显少于对照组。
一种用户佩戴的透视显示器，利用视觉固定目标与稳定的人工地平线相结合，并与用户的运动相匹配，已经证明对易受运动不耐受和空间定向障碍影响的个体以及接受前庭康复的个体具有显著的益处。所开发的技术在任何影响人类表现的运动敏感环境中都有应用。
