Vestibular Testing: Consistency and Effects Over Time

NCT03182868 | Completed Results DMC FDA Device

• 1 other identifier: 20150663
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Dizziness

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (5)

Repeatability Group

EXPERIMENTAL

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

Time of Day Group

EXPERIMENTAL

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

Learning Affect Group

EXPERIMENTAL

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

MSQ Group

EXPERIMENTAL

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

OKN Only Group

EXPERIMENTAL

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

Interventions

PAS Goggle DEVICE

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.

Learning Affect Group; MSQ Group; OKN Only Group; Repeatability Group; Time of Day Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael Hoffer
• Organization: University of Miami

michael.hoffer@miami.edu

305 243-1484

Study Officials

• Michael Hoffer, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 9, 2017
• Study Start: October 29, 2015
• Primary Completion: November 28, 2016
• Study Completion: November 28, 2016
• Last Updated: May 17, 2022
• Results First Posted: September 9, 2021

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)