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Completed

NCT Number: NCT03270839

Motion Sickness Medications and Vestibular Time Constant

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.

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Key information

Conditions

Drug Reaction Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Israeli Navy Medical Institute

Haifa, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bonine 25Mg Chewable Tablet

Drug

Motion sickness drug

Other names: Meclizine

Kwells

Drug

Motion sickness drug

Other names: Scopolamine

Placebo oral tablet

Drug

No active substance in the tablet

Other names: Placebo

Primary outcomes

  1. 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]

  2. 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]

  3. 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]

  4. 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]

  5. 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]

  6. 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]

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Medical Corps, Israel Defense Force

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 1, 2017
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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