Three-Axis Wearable Adaptive Vestibular Stimulator

Motion Sickness Clinical Trial

Official title:

3WAVeS: Three-Axis Wearable Adaptive Vestibular Stimulator

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106256
• Other study ID #: 23-002124
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Motion Sickness

Intervention

Device:
• Galvanic Vestibular Stimulation (GVS)
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

Other:
• Flight simulations in virtual reality (VR)
Highly immersive, 3D virtual flight simulation environment
• 3-DOF Bertec Portable Essential's dual-balance force plate system
Firm surface/plate to stand on while being presented disorienting visual patters of moving vertical and/or horizontal bars of alternating black and white.

Locations

Country	Name	City	State
United States	Mayo Clinic Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pensacola Diagnostic Index-based motion sickness questionnaire	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".	Immediately after each flight stimulation session, approximately 1 hour
Primary	COG Sway velocity	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.	Immediately after balance testing in each session, approximately 1 hour

External Links

•   Mayo Clinic Clinical Trials