ClinicalTrials.gg
CompletedNCT05640258Updated Dec 14, 2022

Seasickness Susceptability and Vestibular Time Constant

An interventional study of rotatory chair testing in a velocity step protocol. in Seasickness, sponsored by Medical Corps, Israel Defense Force. Completed at 1 site in Israel. Open to male participants aged 18 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-14.

Sponsored by Medical Corps, Israel Defense Force · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 5 years 2 months after the study started (first participant enrolled Sep 2017, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Not applicable
Ages
18 Years to 20 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Seasickness

Browse trials for

03

In context

Motion Sickness

50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.

This study's enrollment of 67 is above the median of 59 across 44 interventional studies indexed under Motion Sickness.

Browse Motion Sickness studies →

Lead sponsor

Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 20 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy male Navy sailors in basic training

Exclusion criteria

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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    seasickness susceptibility and vestibular time constant

    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.

    Diagnostic Test: rotatory chair testing in a velocity step protocol.

Interventions

  • Diagnostic testrotatory 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Israeli Naval Medical Institute
    Haifa, 2705335, Israel
08

References and documents

Individual participant data

Plan to share: No — The data that supports the findings of this study are available upon request from the corresponding author, Tal D.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Jan 2020, 28 months.

Of 15 interventional studies with no phase under Motion Sickness, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 29. This study's 28 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2022
First posted
Dec 7, 2022
StartActual
Sep 18, 2017
Primary completionActual
Jan 26, 2020
CompletionActual
Jul 26, 2020
Last update
Dec 14, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05640258
Lead sponsor
Medical Corps, Israel Defense Force
Responsible party
Sponsor
First posted
Dec 7, 2022
Start date
Sep 18, 2017
Primary completion
Jan 26, 2020
Completion
Jul 26, 2020
Last update
Dec 14, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion