Motion Sickness Medications and Vestibular Time Constant

Study Overview
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Brief Summary
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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.

Official Title
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Motion Sickness Medications and Vestibular Time Constant

Conditions
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Drug Reaction

Intervention / Treatment
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* Drug: Bonine 25Mg Chewable Tablet
* Drug: Kwells
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Responsive to Scopolamine (Active)<br>Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day ) | Drug: Kwells<br>* Motion sickness drug<br>* Other names: Scopolamine;|
| Placebo Comparator: Responsive to Scopolamine (Placebo)<br>Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) | Drug: Placebo Oral Tablet<br>* No active substance in the tablet<br>* Other names: Placebo;|
| Active Comparator: Non-responsive to Scopolamine (Active)<br>Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day ) | Drug: Kwells<br>* Motion sickness drug<br>* Other names: Scopolamine;|
| Placebo Comparator: Non-responsive to Scopolamine (Placebo)<br>Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) | Drug: Placebo Oral Tablet<br>* No active substance in the tablet<br>* Other names: Placebo;|
| Active Comparator: Responsive to Meclizine (Active)<br>Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day ) | Drug: Bonine 25Mg Chewable Tablet<br>* Motion sickness drug<br>* Other names: Meclizine;|
| Placebo Comparator: Responsive to Meclizine (Placebo)<br>Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) | Drug: Placebo Oral Tablet<br>* No active substance in the tablet<br>* Other names: Placebo;|
| Active Comparator: Non-responsive to Meclizine (Active)<br>Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day ) | Drug: Bonine 25Mg Chewable Tablet<br>* Motion sickness drug<br>* Other names: Meclizine;|
| Placebo Comparator: Non-responsive to Meclizine (Placebo)<br>Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet) | Drug: Placebo Oral Tablet<br>* No active substance in the tablet<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vestibular Time Constant Change/differential | One of the parameters measured in step velocity test [Sec] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | 
| Step Velocity Test Gain Change/differential | One of the parameters measured in step velocity test [0-1] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | 
| Optokinetic After Nystagmus (OKAN) Gain Change/differential | One of the parameters measured in optokinetic test [0-1] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | 
| Optokinetic After Nystagmus (OKAN) Time Constant Change/differential | One of the parameters measured in optokinetic test [Sec] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | 
| Optokinetic After Nystagmus (OKAN) Slow Phase velocity Sum Change/differential | One of the parameters measured in optokinetic test [Deg/Sec] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | 
| Pupil Size Change/differential | Using pupil size chart [Mm] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | 
| Pupil Accommodation and Convergation Change/differential | Eye test for drugs side effects. | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | 
| Side Effects Questionnaire Change/differential | Questionnaire of drugs' side effects. | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. |