Vestibular Testing: Consistency and Effects Over Time

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.

Study Overview

• Status: Completed
• Conditions: Dizziness
• Intervention / Treatment: Device: PAS Goggle

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

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

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]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Repeatability Group; 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.	Device: PAS Goggle; PAS goggle is a self-contained stimulus and sensing device that is designed to deliver the visual stimuli currently delivered via light projected on a wall while simultaneously recording the movement of the eyes. Each vestibular testing session last about 15 minutes.
EXPERIMENTAL: Time of Day Group; 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.	Device: PAS Goggle; PAS goggle is a self-contained stimulus and sensing device that is designed to deliver the visual stimuli currently delivered via light projected on a wall while simultaneously recording the movement of the eyes. Each vestibular testing session last about 15 minutes.
EXPERIMENTAL: Learning Affect Group; 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.	Device: PAS Goggle; PAS goggle is a self-contained stimulus and sensing device that is designed to deliver the visual stimuli currently delivered via light projected on a wall while simultaneously recording the movement of the eyes. Each vestibular testing session last about 15 minutes.
EXPERIMENTAL: MSQ Group; 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.	Device: PAS Goggle; PAS goggle is a self-contained stimulus and sensing device that is designed to deliver the visual stimuli currently delivered via light projected on a wall while simultaneously recording the movement of the eyes. Each vestibular testing session last about 15 minutes.
EXPERIMENTAL: OKN Only Group; 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.	Device: PAS Goggle; PAS goggle is a self-contained stimulus and sensing device that is designed to deliver the visual stimuli currently delivered via light projected on a wall while simultaneously recording the movement of the eyes. Each vestibular testing session last about 15 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vestibular Reaction Times	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.	2 Days
Vestibular Subjective Visual Vertical	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.	2 Days
Vestibular Smooth Pursuit Horizontal	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.	2 Days
Vestibular Percentage of Saccade	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.	2 Days
Vestibular Anti-Saccade	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.	2 Days
Vestibular Gain	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)	2 Days
Vestibular Saccade Horizontal	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.	2 Days
Vestibular Predictive Saccade	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.	2 Days
Motion Sickness as Measured by the MSAQ	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.	Day 1

Collaborators and Investigators

• Sponsor: University of Miami

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 29, 2015
• Primary Completion (ACTUAL): November 28, 2016
• Study Completion (ACTUAL): November 28, 2016

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (ACTUAL): June 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Sensation Disorders; Dizziness
• Other Study ID Numbers: 20150663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No