Trial Outcomes & Findings for Non-pharmaceutical Motion Sickness Mitigation (NCT NCT04859868)
NCT ID: NCT04859868
Last Updated: 2023-09-28
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
During the rotation of the chair, approximately 1 hr
Results posted on
2023-09-28
Participant Flow
Total of 29 participants were enrolled to receive all interventions, however the order the intervention was received was randomized. All subjects completed the first experimental visit. 2 subjects withdrew from the study prior to the start of the second experimental visit.
Participant milestones
| Measure |
GVS Entire Session, GVS From Mid-Session, Then No GVS
Subjects received Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning for experimental visit 1; subjects received GVS ON from mid-session in the rotating chair for experimental visit 2; subjects received GVS stimulation OFF for entire session in rotating chair for experimental visit 3.
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.
|
GVS Entire Session, No GVS, Then GVS From Mid-Session
Subjects received Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation ON from beginning for experimental visit 1; subjects received GVS stimulation OFF for entire session in rotating chair for experimental visit 2; subjects received GVS ON from mid-session in the rotating chair for experimental visit 3.
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.
|
GVS From Mid-Session, GVS Entire Session, Then No GVS
Subjects received Galvanic Vestibular Stimulation (GVS) ON from mid-session in the rotating chair for experimental visit 1; subjects received GVS to mitigate motion sickness in the rotating chair turning stimulation ON from beginning for experimental visit 2; subjects received GVS stimulation OFF for entire session in rotating chair for experimental visit 3.
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.
|
GVS From Mid-Session, No GVS, Then GVS Entire Session
Subjects received Galvanic Vestibular Stimulation (GVS) ON from mid-session in the rotating chair for experimental visit 1; subjects received GVS stimulation OFF for entire session in rotating chair for experimental visit 2; subjects received GVS to mitigate motion sickness in the rotating chair turning stimulation ON from beginning for experimental visit 3.
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.
|
No GVS, GVS From Mid-Session, Then GVS Entire Session
Subjects received Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation OFF from beginning for experimental visit 1; subjects received GVS ON from mid-session in the rotating chair for experimental visit 2; subjects received GVS stimulation ON for entire session in rotating chair for experimental visit 3.
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.
|
No GVS, GVS Entire Session, Then GVS From Mid-Session
Subjects received Galvanic Vestibular Stimulation (GVS) to mitigate motion sickness in the rotating chair turning stimulation OFF from beginning for experimental visit 1; subjects received GVS stimulation ON for entire session in rotating chair for experimental visit 2; subjects received GVS ON from mid-session in the rotating chair for experimental visit 3.
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.
|
|---|---|---|---|---|---|---|
|
First Experimental Visit (1.5 Hour)
STARTED
|
5
|
5
|
5
|
4
|
5
|
5
|
|
First Experimental Visit (1.5 Hour)
COMPLETED
|
5
|
5
|
5
|
4
|
5
|
5
|
|
First Experimental Visit (1.5 Hour)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Experimental Visit (1.5 Hour)
STARTED
|
4
|
5
|
5
|
4
|
4
|
5
|
|
Second Experimental Visit (1.5 Hour)
COMPLETED
|
4
|
5
|
5
|
4
|
4
|
5
|
|
Second Experimental Visit (1.5 Hour)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Experimental Visit (1.5 Hour)
STARTED
|
4
|
5
|
5
|
4
|
4
|
5
|
|
Third Experimental Visit (1.5 Hour)
COMPLETED
|
4
|
5
|
5
|
4
|
4
|
5
|
|
Third Experimental Visit (1.5 Hour)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Galvanic Vestibular Stimulation
n=29 Participants
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).
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.
|
|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 9.1 • n=29 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=29 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=29 Participants
|
PRIMARY outcome
Timeframe: During the rotation of the chair, approximately 1 hrMotion 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)
Outcome measures
| Measure |
Galvanic Vestibular Stimulation
n=27 Participants
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).
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.
|
|---|---|
|
Motion Perception
No GVS
|
55.3 score on a scale
Standard Deviation 32.2
|
|
Motion Perception
GVS Entire Session
|
49.7 score on a scale
Standard Deviation 34.0
|
|
Motion Perception
GVS from Mid-Session
|
50.1 score on a scale
Standard Deviation 33.6
|
SECONDARY outcome
Timeframe: During the rotation of the chair, approximately 1 hrsubjective experiences of motion sickness in a scale of 0-10 (0=not at all; 10=most severe)
Outcome measures
| Measure |
Galvanic Vestibular Stimulation
n=27 Participants
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).
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.
|
|---|---|
|
Motion Sickness Questionnaire
No GVS
|
3.0 score on a scale
Standard Deviation 2.9
|
|
Motion Sickness Questionnaire
GVS Entire Session
|
3.2 score on a scale
Standard Deviation 3.2
|
|
Motion Sickness Questionnaire
GVS from Mid-Session
|
3.4 score on a scale
Standard Deviation 3.1
|
Adverse Events
Galvanic Vestibular Stimulation During the Entire Session
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Galvanic Vestibular Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Galvanic Vestibular Stimulation Starting From Mid-session
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place