Non-pharmaceutical Motion Sickness Mitigation

NCT ID: NCT04859868

Last Updated: 2023-09-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-12

Study Completion Date

2022-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Galvanic Vestibular Stimulation During the Entire Session

Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning.

Group Type EXPERIMENTAL

Galvanic Vestibular Stimulation

Intervention Type DEVICE

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.

No Galvanic Vestibular Stimulation

Subjects were not given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation entire session.

Group Type NO_INTERVENTION

No interventions assigned to this group

Galvanic Vestibular Stimulation Starting From Mid-session

Subjects given Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from the middle of the session.

Group Type EXPERIMENTAL

Galvanic Vestibular Stimulation

Intervention Type DEVICE

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.

Interventions

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Galvanic Vestibular Stimulation

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Gaurav N. Pradhan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaurav N Pradhan, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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80NSSC21K0175

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20-005763

Identifier Type: -

Identifier Source: org_study_id

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