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Video Head Impulse Test and Seasickness Susceptibility

Primary Purpose

Sea Sickness

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Video-head impulse testing
Sponsored by
Medical Corps, Israel Defense Force
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sea Sickness focused on measuring motion sickness, video head impulse test, vestibular testing, seasickness susceptibility

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Israeli Naval Medical Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

seasickness susceptible

seasickness non-susceptible

Arm Description

43 seasickness susceptible maritime crewmembers underwent video-head impulse test

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

Outcomes

Primary Outcome Measures

vHIT gain
measurement of semicircular canal function
paired semi-circular canal asymmetry
(|1st canal gain-2nd canal gain|)/(1st canal gain+2nd canal gain)

Secondary Outcome Measures

anterior semicircular canal gain o ipsilateral horizontal canal gain
anterior semicircular canal gain o ipsilateral horizontal canal gain

Full Information

First Posted
December 11, 2022
Last Updated
December 11, 2022
Sponsor
Medical Corps, Israel Defense Force
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1. Study Identification

Unique Protocol Identification Number
NCT05657340
Brief Title
Video Head Impulse Test and Seasickness Susceptibility
Official Title
Video Head Impulse Test and Seasickness Susceptibility
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Corps, Israel Defense Force

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sea Sickness
Keywords
motion sickness, video head impulse test, vestibular testing, seasickness susceptibility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
seasickness susceptible
Arm Type
Experimental
Arm Description
43 seasickness susceptible maritime crewmembers underwent video-head impulse test
Arm Title
seasickness non-susceptible
Arm Type
Other
Arm Description
43 seasickness non-susceptible maritime crewmembers underwent video-head impulse test
Intervention Type
Diagnostic Test
Intervention Name(s)
Video-head impulse testing
Intervention Description
Video-head impulse testing is a recent diagnostic bed-side test for evaluation of semi-circular canal function.
Primary Outcome Measure Information:
Title
vHIT gain
Description
measurement of semicircular canal function
Time Frame
Immediate
Title
paired semi-circular canal asymmetry
Description
(|1st canal gain-2nd canal gain|)/(1st canal gain+2nd canal gain)
Time Frame
Immediate
Secondary Outcome Measure Information:
Title
anterior semicircular canal gain o ipsilateral horizontal canal gain
Description
anterior semicircular canal gain o ipsilateral horizontal canal gain
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Israeli Naval Medical Institute
City
Haifa
ZIP/Postal Code
2705335
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Information will be available upon reasonable request from corresponding author

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Video Head Impulse Test and Seasickness Susceptibility

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