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临床试验/NCT05004818
NCT05004818已完成不适用

Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness

Medical Corps, Israel Defense Force0 个研究点目标入组 54 人开始时间: 2016年8月1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
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

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

研究者

发起方
Medical Corps, Israel Defense Force
申办方类型
Other
责任方
Sponsor

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