Sea SicknessNCT05657340
Video Head Impulse Test and Seasickness Susceptibility
A study testing Video-head impulse testing in people with Sea Sickness, run by Medical Corps, Israel Defense Force at 1 site in Israel.
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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sea Sickness
- What is being tested?
- Video-head impulse testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 healthy military naval subjects
- At least six month of active sailing.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sea Sickness
- Being tested
- Video-head impulse testing
- Keywords
- motion sickness, video head impulse test, vestibular testing, seasickness susceptibility
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-head impulse testingDiagnostic test
Video-head impulse testing is a recent diagnostic bed-side test for evaluation of semi-circular canal function.
| Study group | Role | What they receive |
|---|---|---|
| seasickness susceptible | Experimental | 43 seasickness susceptible maritime crewmembers underwent video-head impulse test Receives: Diagnostic Test: Video-head impulse testing |
| seasickness non-susceptible | Other | 43 seasickness non-susceptible maritime crewmembers underwent video-head impulse test Receives: Diagnostic Test: Video-head impulse testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
vHIT gain
measurement of semicircular canal function
Measured: Immediate
paired semi-circular canal asymmetry
(|1st canal gain-2nd canal gain|)/(1st canal gain+2nd canal gain)
Measured: Immediate
Secondary outcomes (1)
anterior semicircular canal gain o ipsilateral horizontal canal gain
anterior semicircular canal gain o ipsilateral horizontal canal gain
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Jan 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sea SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoni Gutkovich, Medical Corps, Israel Defense Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657340
- Sponsor's protocol ID
- IDF-1873-2018
- Status last verified
- Dec 2022
- First submitted
- 11 Dec 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information will be available upon reasonable request from corresponding author
Publications
Gutkovich YE, Jamison A, Lagami D, Fonar Y, Siag K, Tal D. Video head impulse test and seasickness susceptibility. Exp Brain Res. 2025 Apr 16;243(5):119. doi: 10.1007/s00221-025-07078-9.
PubMed 40237844
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Head Impulse Test and Seasickness Susceptibility
- ClinicalTrials.gov ID
- NCT05657340
- Acronym / sponsor ID
- IDF-1873-2018
- Conditions
- Sea Sickness
- Keywords
- motion sickness, video head impulse test, vestibular testing, seasickness susceptibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| seasickness susceptible | Experimental | Diagnostic Test: Video-head impulse testing43 seasickness susceptible maritime crewmembers underwent video-head impulse test |
| seasickness non-susceptible | Other | Diagnostic Test: Video-head impulse testing43 seasickness non-susceptible maritime crewmembers underwent video-head impulse test |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-40 healthy military naval subjects
- At least six month of active sailing.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-head impulse testingVideo-head impulse testing is a recent diagnostic bed-side test for evaluation of semi-circular canal function. | Diagnostic test | seasickness non-susceptible, seasickness susceptible |
Primary outcome
vHIT gain
Time frame: Immediate
measurement of semicircular canal function
paired semi-circular canal asymmetry
Time frame: Immediate
(|1st canal gain-2nd canal gain|)/(1st canal gain+2nd canal gain)
1 secondary outcome
anterior semicircular canal gain o ipsilateral horizontal canal gain
Time frame: Immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Derived from this study: PubMed 40237844Gutkovich YE, Jamison A, Lagami D, Fonar Y, Siag K, Tal D. Video head impulse test and seasickness susceptibility. Exp Brain Res. 2025 Apr 16;243(5):119. doi: 10.1007/s00221-025-07078-9.
- Individual participant dataSharing planned: No. Information will be available upon reasonable request from corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-head impulse testing in people with Sea Sickness, run by Medical Corps, Israel Defense Force at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vHIT gain (time frame: Immediate). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05657340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.