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Completed

NCT Number: NCT05640258

Seasickness Susceptability and Vestibular Time Constant

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.

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Key information

Conditions

Seasickness Motion Sickness Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–20 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Israeli Naval Medical Institute

Haifa, 2705335, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rotatory chair testing in a velocity step protocol.

Diagnostic Test

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 outcomes

  1. 6 month follow up vestibular time constant measurement.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical Corps, Israel Defense Force

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2022
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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