Vestibular Testing: Consistency and Effects Over Time

University of Miami

Status: Completed

Conditions: Dizziness

Treatments: Device: PAS Goggle

Study type: Interventional

Funder types: Other

Identifiers

NCT03182868

20150663

Details and patient eligibility

About

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.

Full 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

Enrollment: 78 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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]

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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78 participants in 5 patient groups

Repeatability Group

Experimental group

Description:

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.

Treatment:

Device: PAS Goggle

Time of Day Group

Experimental group

Description:

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.

Treatment:

Device: PAS Goggle

Learning Affect Group

Experimental group

Description:

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.

Treatment:

Device: PAS Goggle

MSQ Group

Experimental group

Description:

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.

Treatment:

Device: PAS Goggle

OKN Only Group

Experimental group

Description:

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.

Treatment:

Device: PAS Goggle