Video Head Impulse Test and Seasickness Susceptibility

December 11, 2022 updated by: Yoni Gutkovich, Medical Corps, Israel Defense Force

This a case control study on seasickness susceptibility. 86 healthy maritime personal were divided to seasickness susceptible and non susceptible groups based on a seasickness questionnaire (Golding) and motion sickness score.

All subjects from both groups underwent video head impulse testing (vHIT). VHIT parameters - gain, asymmetry ect were compared between both groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Israel
      • Haifa, Israel, 2705335
        • Israeli Naval Medical Institute

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

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-40 healthy military naval subjects
  • At least six month of active sailing.

Exclusion Criteria:

  • A history of hearing loss
  • Ear pathology observed at otoscopic examination
  • A neck injury precluding head movement.
  • Abnormal otoneurological examination findings
  • Subject's withdrawal of informed consent.
  • Failure to complete the video head impulse test.

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: seasickness susceptible
43 seasickness susceptible maritime crewmembers underwent video-head impulse test
Diagnostic test: Video-head impulse testing
Video-head impulse testing is a recent diagnostic bed-side test for evaluation of semi-circular canal function.
Other: seasickness non-susceptible
43 seasickness non-susceptible maritime crewmembers underwent video-head impulse test
Diagnostic test: Video-head impulse testing
Video-head impulse testing is a recent diagnostic bed-side test for evaluation of semi-circular canal function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vHIT gain
Time Frame: Immediate
measurement of semicircular canal function
Immediate
paired semi-circular canal asymmetry
Time Frame: Immediate
(|1st canal gain-2nd canal gain|)/(1st canal gain+2nd canal gain)
Immediate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anterior semicircular canal gain o ipsilateral horizontal canal gain
Time Frame: Immediate
anterior semicircular canal gain o ipsilateral horizontal canal gain
Immediate

Collaborators and Investigators

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

Sponsor

Medical Corps, Israel Defense Force

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)

January 1, 2019

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

December 11, 2022

First Submitted That Met QC Criteria

December 11, 2022

First Posted (Estimate)

December 20, 2022

Study Record Updates

Last Update Posted (Estimate)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 11, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDF-1873-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Information will be available upon reasonable request from corresponding author

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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