DizzinessNCT03182868

Vestibular Testing: Consistency and Effects Over Time

A study testing PAS Goggle in people with Dizziness, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Dizziness
What is being tested?: PAS Goggle
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 1 siteUnited States
Study dates: 29 Oct 2015to 28 Nov 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

University of Miami Miller School of Medicine
Miami, Florida, 33136

Other trials in United States

About this study

Read the 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

Conditions: Dizziness
Being tested: PAS Goggle
Medical subject headings: Dizziness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PAS GoggleDevice
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.

Study groups in NCT03182868
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: PAS Goggle

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 201528 Nov 2016

First posted9 Jun 2017
Study start29 Oct 2015
Primary completion28 Nov 2016
Study completion28 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DizzinessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03182868
Sponsor's protocol ID: 20150663
Status last verified: Apr 2022
First submitted: 7 Jun 2017
Last updated: 17 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
Multiple Sclerosis
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine
RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced

All Dizziness trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vestibular Testing: Consistency and Effects Over Time
ClinicalTrials.gov ID: NCT03182868
Acronym / sponsor ID: 20150663
Conditions: Dizziness
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: 29 Oct 2015 (actual)
Primary completion: 28 Nov 2016 (actual)
Study completion: 28 Nov 2016 (actual)
First posted: 9 Jun 2017 (actual)
Results: Posted 9 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Repeatability Group	Experimental	Device: PAS GoggleHealthy 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.
Time of Day Group	Experimental	Device: PAS GoggleHealthy 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.
Learning Affect Group	Experimental	Device: PAS GoggleHealthy 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.
MSQ Group	Experimental	Device: PAS GoggleHealthy 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.
OKN Only Group	Experimental	Device: PAS GoggleOKN 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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]

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PAS GogglePAS 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.	Device	Learning Affect Group, MSQ Group, OKN Only Group, Repeatability Group, Time of Day Group

Primary outcome

Vestibular Reaction Times
Time frame: 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 Subjective Visual Vertical
Time frame: 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 Smooth Pursuit Horizontal
Time frame: 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
Time frame: 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
Time frame: 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 Gain
Time frame: 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
Time frame: 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 Predictive Saccade
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 9 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Repeatability Group	12	9
Time of Day Group	20	20
Learning Affect Group	21	17
MSQ Group	1	0
OKN Only Group	24	16

Primary outcome: Vestibular Reaction Times

Time frame: 2 Days. Mean (Standard Deviation). Unit: msec

Measure	Repeatability Group n = 9	Time of Day Group n = 20	Learning Affect Group n = 17
ART Session 1	240.89 (61.81)	202.96 (41.43)	233.09 (65.70)
ART Session 2	228.95 (59.15)	202.27 (57.42)	213.07 (53.63)
VRT Session 1	237.14 (47.89)	212.21 (26.38)	224.74 (42.22)
VRT Session 2	229.52 (53.53)	218.34 (30.73)	230.63 (48.68)
SRT Motor Latency Session 1	0.53 (0.11)	0.41 (0.11)	0.44 (0.14)
SRT Motor Latency Session 2	0.49 (0.11)	0.38 (0.11)	0.44 (0.13)
SRT Saccade Latency Session 1	0.20 (0.04)	0.18 (0.03)	0.20 (0.06)
SRT Saccade Latency Session 2	0.18 (0.03)	0.19 (0.03)	0.20 (0.05)

Population analysed: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.

Primary outcome: Vestibular Subjective Visual Vertical

Time frame: 2 Days. Mean (Standard Deviation). Unit: degrees

Measure	Repeatability Group n = 9	Time of Day Group n = 20	Learning Affect Group n = 17
Session 1	2.08 (1.61)	2.04 (2.36)	1.21 (2.02)
Session 2	1.52 (1.81)	1.52 (2.17)	1.64 (1.87)

Population analysed: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.

Primary outcome: Vestibular Smooth Pursuit Horizontal

Time frame: 2 Days. Mean (Standard Deviation). Unit: degree squared per second

Measure	Repeatability Group n = 9	Time of Day Group n = 20	Learning Affect Group n = 17
Session 1	10006 (815)	10739 (849)	10303 (905)
Session 2	9986 (754)	10450 (818)	10219 (1009)

Population analysed: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.

Primary outcome: Vestibular Percentage of Saccade

Time frame: 2 Days. Mean (Standard Deviation). Unit: percentage

Measure	Repeatability Group n = 9	Time of Day Group n = 20	Learning Affect Group n = 17
SPH Session 1	12.83 (12.14)	16.49 (9.80)	21.23 (13.70)
SPH Session 2	12.72 (5.79)	14.38 (8.38)	18.23 (9.43)

Population analysed: Participants in the Repeatability, Time of Day and Learning Affect Groups were the only intended participants to be assessed for this outcome.

Adverse events

Time frame: Up to 2 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Repeatability Group	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Time of Day Group	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Learning Affect Group	0 of 21 (0%)	0 of 21 (0%)	0 of 21
MSQ Group	0 of 1 (0%)	0 of 1 (0%)	0 of 1
OKN Only Group	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Dizziness

Recruiting
Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
Multiple Sclerosis
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine
RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Hoffer, MD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PAS Goggle in people with Dizziness, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vestibular Reaction Times (time frame: 2 Days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03182868.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.