SeasicknessNCT05640258
Seasickness Susceptability and Vestibular Time Constant
A study testing rotatory chair testing in a velocity step protocol. in people with Seasickness, run by Medical Corps, Israel Defense Force at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Seasickness
- What is being tested?
- rotatory chair testing in a velocity step protocol.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Sep 2017to 26 Jul 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 20 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male Navy sailors in basic training
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Seasickness
- Being tested
- rotatory chair testing in a velocity step protocol.
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: rotatory chair testing in a velocity step protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start18 Sep 2017
- Primary completion26 Jan 2020
- Study completion26 Jul 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 SeasicknessStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640258
- Sponsor's protocol ID
- IDF-1710-2016
- Status last verified
- Nov 2022
- First submitted
- 28 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that supports the findings of this study are available upon request from the corresponding author, Tal D.
Publications
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.
PubMed 38015244
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seasickness Susceptability and Vestibular Time Constant
- ClinicalTrials.gov ID
- NCT05640258
- Acronym / sponsor ID
- IDF-1710-2016
- Conditions
- Seasickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 26 Jan 2020 (actual)
- Study completion
- 26 Jul 2020 (actual)
- First posted
- 7 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| seasickness susceptibility and vestibular time constant | Experimental | Diagnostic Test: rotatory chair testing in a velocity step protocol.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. |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy male Navy sailors in basic training
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| 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. | Diagnostic test | seasickness susceptibility and vestibular time constant |
Primary outcome
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.
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 14 Dec 2022.
- Derived from this study: PubMed 38015244Lagami 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.
- Individual participant dataSharing planned: No. The data that supports the findings of this study are available upon request from the corresponding author, Tal D.
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 rotatory chair testing in a velocity step protocol. in people with Seasickness, 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 1 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 14 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?
6 month follow up vestibular time constant measurement. (time frame: 6 months). 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 NCT05640258, 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 14 Dec 2022; AzTrials last refreshed its copy on 29 Oct 2026.