Vestibular Testing: Consistency and Effects Over Time

Not Applicable

Completed

• Conditions: Dizziness
• Interventions: Device: PAS Goggle

• Registration Number: NCT03182868
• Lead Sponsor: University of Miami

Brief Summary

The goal of this study is to test the consistency and repeatability of a portable goggle system for testing optokinetic, ocular, and reaction time. The study examines the day to day consistency, time of day and learning effects as well as any secondary motion sickness.

Detailed Description

The goal of this study was to test the constancy and repeatability of this test by testing it in different individuals and different times of day, after a variety of tasks and after repeated performance

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-10-29
• Primary Completion: 2016-11-28
• Study Completion: 2016-11-28
• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-09
• Results First Submitted: 2019-10-01
• Results First Submitted QC: 2021-09-03
• Results First Posted: 2021-09-09
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Age 18 to 65
• Both Females and males
• Staff and students at all levels at the University of Miami or first-degree - relatives/significant others of those individuals.

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Exclusion Criteria

• History of vestibular disorder/dysfunction
• Central processing disorder
• Impaired vision without corrective lenses (max 20/60 uncorrected)
• Moderate to severe hearing loss [>55 decibel (dB) Pure Tone Average (PTA), <50% word identification]

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Repeatability Group	PAS Goggle	Healthy participants perform goggle testing on two consecutive days to determine if the testing results are repeatable. Testing will be between 10 am and 2 pm and testing on the two sessions will be within 30 minutes of the same time. Sessions can be on two consecutive days or separated by up to 4 days.
Learning Affect Group	PAS Goggle	Healthy participants perform goggle testing back to back on the same day to determine if performance on second test changes from first test suggesting a learning affect.
OKN Only Group	PAS Goggle	OKN Only Group is for exploratory aims only. Healthy participants will undergo goggle testing limited to Optokinetic Nystagmus (OKN) recordings at two stimulus speeds (20 and 60 deg/s) in both the counterclockwise and clockwise directions.
Time of Day Group	PAS Goggle	Healthy participants perform goggle testing at two different times of day to determine if time of day affects goggle testing performance. One quarter of the participants in this arm will undergo one test at 8 am on the first session and 10 am on the second session. A second quarter will undergo the tests at 10 am on first session and 8 am on the second session. A third quarter will undergo one test at 3 pm on the first session and 10 am on the second session. The fourth quarter will undergo the tests at 10 am on first session and 3 pm on the second session. In all these cases the sessions can be on consecutive days or separated by up to 4 days.
MSQ Group	PAS Goggle	Healthy participants perform goggle testing and upon completion of each goggle testing session will complete a Motion Sickness Questionnaire (MSQ) to determine if they show any signs of motion sickness.

Primary Outcome Measures

Name	Time	Method
Vestibular Subjective Visual Vertical	2 Days	Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the Subjective Visual Vertical sub-test assessed in degrees.
Vestibular Reaction Times	2 Days	Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the following sub-tests: a) Visual Reactive Time (VRT), b) Saccades and Reaction Time (SRT) Saccade Latency, c) SRT Motor Latency, and d) Auditory Reaction Time (ART). ART, VRT and SRT subtests are all evaluated in msec.
Vestibular Gain	2 Days	Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the following sub-tests: a) OKN at 60 degrees/second, and b) Smooth Percent Horizontal Velocity. Subtests are all evaluated in gain (output/input in decimal form)
Vestibular Saccade Horizontal	2 Days	Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the Saccade Horizontal sub-tests evaluated in seconds.
Vestibular Smooth Pursuit Horizontal	2 Days	Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the Smooth Pursuit Horizontal (SPH) sub-tests in degree squared per second.
Vestibular Percentage of Saccade	2 Days	Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the sub-tests Smooth Pursuit Horizontal (SPH) evaluated as percentage of saccades completed.
Vestibular Anti-Saccade	2 Days	Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the Anti-saccade sub-test evaluted in Percent Error.
Vestibular Predictive Saccade	2 Days	Repeatability, variation and learning effect of vestibular testing of PAS goggles will be evaluated using the test results on both sessions for the subtest Predictive Saccade (PS) evaluated as percentage of prediction.
Motion Sickness as Measured by the MSAQ	Day 1	Motion sickness is measured by the subjects being given a motion sickness assessment questionnaire (MSAQ). The MSAQ is a validated measure of motion sickness and in this questionnaire the examiner asks subjects 16 questions. Subjects score each question as "not at all" (score of zero) or on a seventy scale of 1-9. The total score ranging from 0-144 with the score reported as a percentage. The higher percentage score indicates more motion symptoms experienced by the subjects.

Trial Locations

Locations (1)

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States