Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2019-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

subjects with severe seasickness, who failed to habituate to sea conditions after at least six month of active sailing, were enrolled to the single-blind randomized control study. The intervention group was treated with rotatory chair stimulation at sinusoidal harmonic acceleration protocol coupled with galvanic vestibular stimulation to the mastoid processes. This unique procedure was hypothesized to promote habituation to seasickness. The control group underwent a sham procedure. All study participants filled out seasickness questionnaires at set time points following the intervention and underwent repeated step testing to determine their vestibular time constant. The number of anti-motion sickness clinic visits and scopolamine prescriptions was also recorded in the three months period following the intervention.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Seasickness Susceptability and Vestibular Time Constant

NCT05640258

Seasickness

COMPLETED NA

Video Head Impulse Test and Seasickness Susceptibility

NCT05657340

Sea Sickness

COMPLETED NA

A Double-blind Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness

NCT01198106

Simulator Sickness

UNKNOWN NA

Motion Sickness Medications and Vestibular Time Constant

NCT03270839

Drug Reaction

COMPLETED PHASE4

Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Visually Induced Motion Sickness in Healthy Volunteers

NCT02177890

Visually Induced Motion Sickness in Healthy Volunteers

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Motion Sickness Seasickness Habituation Vestibular Time Constant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

sham procedure

Participants with severe motion sickness were sited in the the rotatory chair with the videonystagmography recorder masking their eyes, while two galvanic vestibular stimulation electrodes were connected to the mastoid processes. No active stimulus was given.

Group Type SHAM_COMPARATOR

Sham procedure

Intervention Type PROCEDURE

Participants with severe motion sickness were sited in the the rotatory chair with the videonystagmography recorder masking their eyes, while two galvanic vestibular stimulation electrodes were connected to the mastoid processes. No active stimulus was given.

GVS stimulation coupled with inverse phase rotatory chair stimulation

Participants with severe motion sickness were sited in the the rotatory chair with the videonystagmography recorder masking their eyes, while two galvanic vestibular stimulation electrodes were connected to the mastoid processes. The rotatory chair was activated in sinusoidal harmonic acceleration protocol in inverse phase to galvanic vestibular stimulation.

Group Type EXPERIMENTAL

GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol

Intervention Type PROCEDURE

GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol

Intervention Type PROCEDURE

Sham procedure

Participants with severe motion sickness were sited in the the rotatory chair with the videonystagmography recorder masking their eyes, while two galvanic vestibular stimulation electrodes were connected to the mastoid processes. No active stimulus was given.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* maximum score of 7 on the Wiker seasickness questionnaire in moderate sea conditions, with wave height of 0 - 1.5 m
* All had been sailing regularly for at least six months before enrolling in the study

Exclusion Criteria

* history of hearing loss
* otoscopic findings of ear pathology
* an implanted electrode
* a finding of vestibulopathy on otoneurologic examination
* withdrawal by any subject of his informed consent.

Minimum Eligible Age

19 Years

Maximum Eligible Age

44 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes