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OpenTrials
Active, Not Recruiting

NCT Number: NCT06106256

Three-Axis Wearable Adaptive Vestibular Stimulator

The purpose of this study is to improve current galvanic vestibular stimulation (GVS) technology to ease the motion sickness often associated with virtual reality (VR) simulation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Motion Sickness Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

About this study

The Three-Axis Wearable Adaptive Vestibular Stimulator (3WAVeS) technology that combines galvanic vestibular stimulation (GVS) and Virtual Reality (VR) will not only increase VR-based simulation realism and presence, but will also mitigate the motion sickness often associated with VR simulation by re-coupling the vestibular and ocular inputs to the VR user. Additionally, due to GVS technology's ability to accurately provide continuous inputs to the vestibular system, 3WAVeS can intentionally simulate high-fidelity effects of spatial disorientation for training purposes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For our purposes, participants must be able to consent to participate themselves and be 21 to 55 years of age
  • Must be able to attend in-person sessions at the Mayo Aerospace Medicine and Vestibular Research Laboratory in Scottsdale, AZ.
  • No racial/ethnic groups will be excluded, although all participants must be fluent speakers of English.

Exclusion criteria

  • History of vestibular disease, migraine, or significant balance disorder; history of severe motion sensitivity, women who are pregnant.

Treatment and study plan

Galvanic Vestibular Stimulation (GVS)

Device

Four electrodes, forehead, behind both ears, and back of your neck, provide bidirectional electrical stimulation and receive information about the amplitude delivered accounting for skin impedance

Flight simulations in virtual reality (VR)

Other

Highly immersive, 3D virtual flight simulation environment

3-DOF Bertec Portable Essential's dual-balance force plate system

Other

Firm surface/plate to stand on while being presented disorienting visual patters of moving vertical and/or horizontal bars of alternating black and white.

Primary outcomes

  1. Pensacola Diagnostic Index-based motion sickness questionnaire

    Time frame: Immediately after each flight stimulation session, approximately 1 hour

    This index allowed a comparison of motion sickness severity across subjects that may each present with a different constellation of symptoms like nausea, skin color, sweating, salivation, drowsiness, headache, and dizziness. The approach is to have the subject and/or observer grade the subjective intensity of different modalities of symptoms and signs (described below) as slight, moderate or severe. Overall motion sickness severity is then derived from a sum of scores resulting in a weighted "malaise index".

  2. COG Sway velocity

    Time frame: Immediately after balance testing in each session, approximately 1 hour

    The sway angle of the center of gravity (COG) is the measure the amount of sway in any direction. The COG sway velocity is the ratio of the distance traveled by the COG (degrees) to the time (sec) of the trial.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

3WAVeS: Three-Axis Wearable Adaptive Vestibular Stimulator

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 30, 2023
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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