Motion Sickness Medications and Vestibular Time Constant

August 31, 2017 updated by: Dror Tal, Medical Corps, Israel Defense Force

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Haifa, Israel
        • Recruiting
        • Israeli Navy Medical Institute
        • Contact:
        • Sub-Investigator:
          • Daniel Lagami, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vestibular Time Constant Change/differential
Time Frame: 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]
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
Time Frame: 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]
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
Time Frame: 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]
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
Time Frame: 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]
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
Time Frame: 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]
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
Time Frame: 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]
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
Time Frame: 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.
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
Time Frame: 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.
Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dror Tal, PhD, Head of Motion Sickness and Human Performance Laboratory, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

April 2, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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