Back to resultsNon-pharmaceutical Motion Sickness Mitigation
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Galvanic Vestibular Stimulation
Sponsored by
About this trial
This is an interventional prevention trial for Healthy
Eligibility Criteria
Inclusion Criteria:
- Must be able to consent to participate themselves.
- Must 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.
- Must be fluent speakers of English.
Exclusion Criteria:
- History of vestibular disease, migraine, or significant balance disorder.
- Traumatic brain injury.
- Recent middle ear infection or recent motion sickness (within 72 hours).
- History of severe motion sensitivity.
- Women who are pregnant.
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Experimental
Arm Label
Galvanic Vestibular Stimulation During the Entire Session
No Galvanic Vestibular Stimulation
Galvanic Vestibular Stimulation Starting From Mid-session
Arm Description
Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning.
Subjects were not given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation entire session.
Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from the middle of the session.
Outcomes
Primary Outcome Measures
Motion Perception
Motion Perception verbal report using a visual analog scale (1-100) will be recorded during the rotation of the chair (1=feeling no motion perception; 100=feeling the maximum motion perception)
Secondary Outcome Measures
Motion Sickness Questionnaire
subjective experiences of motion sickness in a scale of 0-10 (0=not at all; 10=most severe)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04859868
Brief Title
Non-pharmaceutical Motion Sickness Mitigation
Official Title
Non-pharmaceutical Motion Sickness Mitigation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 12, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is evaluate the effect of timing and magnitude on the administration of our nonpharmaceutical treatment to motion sickness, and to evaluate the effect of Galvanic Vestibular Stimulation (GVR) amplitude on functional fitness task performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Subjects attend four visits of the experiment on four separate days. Each visit will be an hour and a half long. In the first visit, subjects will perform batteries of tests that involve balance, cognition, and determine motion perception at different current levels using a rotating chair. In the next three visits, researchers will test the Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair be either turning stimulation ON from beginning, or middle or by not turning ON (the order will be randomized).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Galvanic Vestibular Stimulation During the Entire Session
Arm Type
Experimental
Arm Description
Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning.
Arm Title
No Galvanic Vestibular Stimulation
Arm Type
No Intervention
Arm Description
Subjects were not given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation entire session.
Arm Title
Galvanic Vestibular Stimulation Starting From Mid-session
Arm Type
Experimental
Arm Description
Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from the middle of the session.
Intervention Type
Device
Intervention Name(s)
Galvanic Vestibular Stimulation
Intervention Description
Low electrical currents to the vestibular system, to induce the realistic sensation of motion (i.e., the g-forces that occur during flight) as well as null out motion perception.
Primary Outcome Measure Information:
Title
Motion Perception
Description
Motion Perception verbal report using a visual analog scale (1-100) will be recorded during the rotation of the chair (1=feeling no motion perception; 100=feeling the maximum motion perception)
Time Frame
During the rotation of the chair, approximately 1 hr
Secondary Outcome Measure Information:
Title
Motion Sickness Questionnaire
Description
subjective experiences of motion sickness in a scale of 0-10 (0=not at all; 10=most severe)
Time Frame
During the rotation of the chair, approximately 1 hr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be able to consent to participate themselves.
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.
Must be fluent speakers of English.
Exclusion Criteria:
History of vestibular disease, migraine, or significant balance disorder.
Traumatic brain injury.
Recent middle ear infection or recent motion sickness (within 72 hours).
History of severe motion sensitivity.
Women who are pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaurav N Pradhan, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Non-pharmaceutical Motion Sickness Mitigation
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