Motion Sickness Medications and Vestibular Time Constant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Optokinetic After Nystagmus (OKAN) Slow Phase velocity Sum Change/differential
研究概览
简要总结
Sea sickness represents a major limitation on the performance of ships' crew. One of the challenges faced by the physician in the motion sickness clinic when prescribing anti-sea sickness medication is to select the appropriate drug for the patient. Difficulties arise due to high variability in the response to different drugs. In the case of sea sickness, the current procedure is to examine the drug's efficacy in each individual during real time exposure to sea conditions.
A number of studies have documented the presence of sea sickness drug receptors in the vestibular nuclei, which determine the vestibular time constant. Two clinical vestibular tests which evaluate the time constant are the Velocity Step and OKAN tests. The purpose of the proposed study is to evaluate the influence of motion sickness drugs on the vestibular time constant, as a possible bioequivalent of drug potency in the individual subject. Eighty crew members will be recruited and divided into groups responsive and non-responsive to the sea sickness drugs scopolamine and meclizine.
Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and no improvement in symptoms after treatment will be defined as non-responsive to sea sickness drugs. Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and a Wiker score of 4 or less after treatment, will be defined as responsive to drug therapy.
Kwells, Bonine and placebo, will be assigned to each subject in a random, double-blind fashion. Each group will perform the Velocity Step and OKAN tests before, one and two hours after drug or placebo administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy soldiers between the ages of 18 to 40, who suffering from sea sickness
- •48 hours prior to session without any use of medications
- •Soldiers who vomit in waves 1.5 meter high without drugs treatment
排除标准
- •Anamnestic hearing Impairment
- •Ear infection of any kind
- •Pathological finding in an otoneurological examination, witch will be done by a trained neurophysiologist / a physician. In any case of pathological finding, patient will be advised to continue medical assesment.
- •Vision pathologies the interfere with VNG test.
- •Withdrawal of informed consent by the patient of any cause.
研究组 & 干预措施
Responsive to Scopolamine (Placebo)
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
干预措施: Placebo Oral Tablet (Drug)
Responsive to Scopolamine (Active)
Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day )
干预措施: Kwells (Drug)
Non-responsive to Scopolamine (Active)
Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day )
干预措施: Kwells (Drug)
Non-responsive to Scopolamine (Placebo)
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
干预措施: Placebo Oral Tablet (Drug)
Responsive to Meclizine (Active)
Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day )
干预措施: Bonine 25Mg Chewable Tablet (Drug)
Responsive to Meclizine (Placebo)
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
干预措施: Placebo Oral Tablet (Drug)
Non-responsive to Meclizine (Active)
Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day )
干预措施: Bonine 25Mg Chewable Tablet (Drug)
Non-responsive to Meclizine (Placebo)
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Optokinetic After Nystagmus (OKAN) Slow Phase velocity Sum Change/differential
时间窗: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
One of the parameters measured in optokinetic test \[Deg/Sec\]
Pupil Accommodation and Convergation Change/differential
时间窗: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
Eye test for drugs side effects.
Step Velocity Test Gain Change/differential
时间窗: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
One of the parameters measured in step velocity test \[0-1\]
Optokinetic After Nystagmus (OKAN) Gain Change/differential
时间窗: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
One of the parameters measured in optokinetic test \[0-1\]
Optokinetic After Nystagmus (OKAN) Time Constant Change/differential
时间窗: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
One of the parameters measured in optokinetic test \[Sec\]
Vestibular Time Constant Change/differential
时间窗: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
One of the parameters measured in step velocity test \[Sec\]
Pupil Size Change/differential
时间窗: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
Using pupil size chart \[Mm\]
Side Effects Questionnaire Change/differential
时间窗: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.
Questionnaire of drugs' side effects.
次要结局
未报告次要终点
研究者
Dror Tal
Head of Motion Sickness and Human Performance Laboratory, Principal Investigator
Medical Corps, Israel Defense Force