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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05657340
Other study ID # IDF-1873-2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date May 1, 2020

Study information

Verified date December 2022
Source Medical Corps, Israel Defense Force
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This a case control study on seasickness susceptibility. 86 healthy maritime personal were divided to seasickness susceptible and non susceptible groups based on a seasickness questionnaire (Golding) and motion sickness score. All subjects from both groups underwent video head impulse testing (vHIT). VHIT parameters - gain, asymmetry ect were compared between both groups.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date May 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 18-40 healthy military naval subjects - At least six month of active sailing. Exclusion Criteria: - A history of hearing loss - Ear pathology observed at otoscopic examination - A neck injury precluding head movement. - Abnormal otoneurological examination findings - Subject's withdrawal of informed consent. - Failure to complete the video head impulse test.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Video-head impulse testing
Video-head impulse testing is a recent diagnostic bed-side test for evaluation of semi-circular canal function.

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 vHIT gain measurement of semicircular canal function Immediate
Primary paired semi-circular canal asymmetry (|1st canal gain-2nd canal gain|)/(1st canal gain+2nd canal gain) Immediate
Secondary anterior semicircular canal gain o ipsilateral horizontal canal gain anterior semicircular canal gain o ipsilateral horizontal canal gain Immediate
See also
  Status Clinical Trial Phase
Completed NCT02911402 - Motion Sickness on Astrolabe's Vessel
Recruiting NCT05886660 - Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance Phase 2