Seasickness Susceptability and Vestibular Time Constant

Sponsor

Medical Corps, Israel Defense Force (Other)

Overall Status

Completed

CT.gov ID

NCT05640258

Collaborator

(none)

Enrollment

Location

Arm

34.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Seasickness	Diagnostic Test: rotatory chair testing in a velocity step protocol.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Seasickness Susceptability and Vestibular Time Constant

Actual Study Start Date :

Sep 18, 2017

Actual Primary Completion Date :

Jan 26, 2020

Actual Study Completion Date :

Jul 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: seasickness susceptibility and vestibular time constant 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.	Diagnostic Test: rotatory chair testing in a velocity step protocol. 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.

Arm

Intervention/Treatment

Experimental: seasickness susceptibility and vestibular time constant

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.

Diagnostic Test: rotatory chair testing in a velocity step protocol.

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.

Outcome Measures

Primary Outcome Measures

6 month follow up vestibular time constant measurement. [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 20 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Israeli Naval Medical Institute	Haifa		Israel	2705335

Sponsors and Collaborators

Medical Corps, Israel Defense Force

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical Corps, Israel Defense Force

ClinicalTrials.gov Identifier:

NCT05640258

Other Study ID Numbers:

IDF-1710-2016

First Posted:

Dec 7, 2022

Last Update Posted:

Dec 14, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Motion Sickness

Study Results

No Results Posted as of Dec 14, 2022