NCT05657340

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

1.3 years

First QC Date

December 11, 2022

Last Update Submit

December 11, 2022

Conditions

Keywords

motion sicknessvideo head impulse testvestibular testingseasickness susceptibility

Outcome Measures

Primary Outcomes (2)

  • vHIT gain

    measurement of semicircular canal function

    Immediate

  • paired semi-circular canal asymmetry

    (\|1st canal gain-2nd canal gain\|)/(1st canal gain+2nd canal gain)

    Immediate

Secondary Outcomes (1)

  • anterior semicircular canal gain o ipsilateral horizontal canal gain

    Immediate

Study Arms (2)

seasickness susceptible

EXPERIMENTAL

43 seasickness susceptible maritime crewmembers underwent video-head impulse test

Diagnostic Test: Video-head impulse testing

seasickness non-susceptible

OTHER

43 seasickness non-susceptible maritime crewmembers underwent video-head impulse test

Diagnostic Test: Video-head impulse testing

Interventions

Video-head impulse testing is a recent diagnostic bed-side test for evaluation of semi-circular canal function.

seasickness non-susceptibleseasickness susceptible

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Israeli Naval Medical Institute

Haifa, 2705335, Israel

Location

Related Publications (1)

  • Gutkovich YE, Jamison A, Lagami D, Fonar Y, Siag K, Tal D. Video head impulse test and seasickness susceptibility. Exp Brain Res. 2025 Apr 16;243(5):119. doi: 10.1007/s00221-025-07078-9.

MeSH Terms

Conditions

Motion Sickness

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 11, 2022

First Posted

December 20, 2022

Study Start

January 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

December 20, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Information will be available upon reasonable request from corresponding author

Locations