Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 主要终点
- Vestibular time constant
研究概览
简要总结
subjects with severe seasickness, who failed to habituate to sea conditions after at least six month of active sailing, were enrolled to the single-blind randomized control study. The intervention group was treated with rotatory chair stimulation at sinusoidal harmonic acceleration protocol coupled with galvanic vestibular stimulation to the mastoid processes. This unique procedure was hypothesized to promote habituation to seasickness. The control group underwent a sham procedure. All study participants filled out seasickness questionnaires at set time points following the intervention and underwent repeated step testing to determine their vestibular time constant. The number of anti-motion sickness clinic visits and scopolamine prescriptions was also recorded in the three months period following the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 44 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •maximum score of 7 on the Wiker seasickness questionnaire in moderate sea conditions, with wave height of 0 - 1.5 m
- •All had been sailing regularly for at least six months before enrolling in the study
排除标准
- •history of hearing loss
- •otoscopic findings of ear pathology
- •an implanted electrode
- •a finding of vestibulopathy on otoneurologic examination
- •withdrawal by any subject of his informed consent.
结局指标
主要结局
Vestibular time constant
时间窗: Until one month following the intervention
Vestibular time constant was measured using repeated rotatory chair stimulation in step protocol.
Seasickness severity
时间窗: Until one month following the intervention
Seasickness severity as determined by Wiker questionnaire at set time frames following the intervention
Anti-motion sickness clinic visits
时间窗: Until three months following the intervention
Anti-motion sickness clinic visits were calculated for each participant and compared between the two groups
scopolamine drug prescription
时间窗: Until three months following the intervention
scopolamine drug prescriptions were calculated for each participant and compared between the two groups
次要结局
未报告次要终点
