NCT05640258

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
Last Updated

December 14, 2022

Status Verified

November 1, 2022

Enrollment Period

2.4 years

First QC Date

November 28, 2022

Last Update Submit

December 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (1)

seasickness susceptibility and vestibular time constant

EXPERIMENTAL

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.

Interventions

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.

seasickness susceptibility and vestibular time constant

Eligibility Criteria

Age18 Years - 20 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male Navy sailors in basic training

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Israeli Naval Medical Institute

Haifa, 2705335, Israel

Location

Related Publications (1)

  • Lagami D, Gutkovich YE, Jamison A, Fonar Y, Tal D. Seasickness susceptibility and the vestibular time constant: a prospective study. Exp Brain Res. 2024 Jan;242(1):267-274. doi: 10.1007/s00221-023-06745-z. Epub 2023 Nov 28.

MeSH Terms

Conditions

Motion Sickness

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 7, 2022

Study Start

September 18, 2017

Primary Completion

January 26, 2020

Study Completion

July 26, 2020

Last Updated

December 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

The data that supports the findings of this study are available upon request from the corresponding author, Tal D.

Locations