Seasickness Susceptability and Vestibular Time Constant

Seasickness Clinical Trial

Official title:

Seasickness Susceptability and Vestibular Time Constant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05640258
• Other study ID #: IDF-1710-2016
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: July 26, 2020

Study information

• Verified date: November 2022
• Source: Medical Corps, Israel Defense Force
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 26, 2020
• Est. primary completion date: January 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Motion Sickness
• Seasickness

Intervention

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.

Locations

Country	Name	City	State
Israel	Israeli Naval Medical Institute	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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