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Seasickness Susceptability and Vestibular Time Constant

Primary Purpose

Seasickness

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
rotatory chair testing in a velocity step protocol.
Sponsored by
Medical Corps, Israel Defense Force
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Seasickness

Eligibility Criteria

18 Years - 20 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: healthy male Navy sailors in basic training Exclusion Criteria: History of hearing loss Otoscopic findings of ear pathology An implanted electrode A finding of vestibulopathy upon otoneurological examination - Discontinuation of active sailing for any reason during study follow-up Withdrawal of informed consent.

Sites / Locations

  • Israeli Naval Medical Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

seasickness susceptibility and vestibular time constant

Arm Description

All study participants underwent rotatory chair testing in a velocity step protocol to determine the Vestibular time constant. testing were preformed at baseline, before commencing active duty on a ship, 3 month and 6 month follow up after the beginning of active sailing.

Outcomes

Primary Outcome Measures

6 month follow up vestibular time constant measurement.
vestibular time constant in seconds is the measurement of decline in maximal slow phase velocity of eye movement during nystagmus to 37% of initial value produced by abrupt acceleration and declarations in a rotatory chair - step velocity protocol.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2022
Last Updated
December 12, 2022
Sponsor
Medical Corps, Israel Defense Force
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1. Study Identification

Unique Protocol Identification Number
NCT05640258
Brief Title
Seasickness Susceptability and Vestibular Time Constant
Official Title
Seasickness Susceptability and Vestibular Time Constant
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
January 26, 2020 (Actual)
Study Completion Date
July 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Participants were selected from the military navy crewmembers prior to commencing of active sailing. A vestibular time constant was calculated based on velocity step testing on a rotatory chair at baseline, 3 months and 6 month following active sailing duty. A seasickness questionnaire (WIKER) was completed during follow-up visits. study participants were divided to three groups based on WIKER score - susceptible , non-susceptible and habituating. Vestibular time constant was compared between study groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasickness

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
seasickness susceptibility and vestibular time constant
Arm Type
Experimental
Arm Description
All study participants underwent rotatory chair testing in a velocity step protocol to determine the Vestibular time constant. testing were preformed at baseline, before commencing active duty on a ship, 3 month and 6 month follow up after the beginning of active sailing.
Intervention Type
Diagnostic Test
Intervention Name(s)
rotatory chair testing in a velocity step protocol.
Intervention Description
Tc was evaluated by the rotational velocity step test using the OtoaccessTM interface (Interacoustics Nydiag 200, Middlefart, Denmark). Subjects were seated on the rotatory chair wearing videonystagmography goggles with their heads supported and tilted 30° forward, thus bringing the horizontal semicircular canals plane perpendicular to the axis of rotation. Standard videonystagmography techniques were employed to record eye-movements. Subsequent to eye movements' calibration, the chair was accelerated about the yaw axis at 30°/sec2 to a maximal velocity of 90°/sec, followed by rotation at a constant velocity. After 57 seconds of constant velocity rotation, the chair was decelerated to zero velocity at 30°/sec2. The described velocity step was conducted both clockwise and counter-clockwise, giving a total run time of 4 minutes.
Primary Outcome Measure Information:
Title
6 month follow up vestibular time constant measurement.
Description
vestibular time constant in seconds is the measurement of decline in maximal slow phase velocity of eye movement during nystagmus to 37% of initial value produced by abrupt acceleration and declarations in a rotatory chair - step velocity protocol.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy male Navy sailors in basic training Exclusion Criteria: History of hearing loss Otoscopic findings of ear pathology An implanted electrode A finding of vestibulopathy upon otoneurological examination - Discontinuation of active sailing for any reason during study follow-up Withdrawal of informed consent.
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
The data that supports the findings of this study are available upon request from the corresponding author, Tal D.

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Seasickness Susceptability and Vestibular Time Constant

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