Vestibular Function TestsNCT03618199
Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing
A study testing Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing in people with Vestibular Function Tests and Dizziness, run by Otolith Labs at 1 site in United States.
Trial summary
Vestibular disorders are among the most common causes of disability in society. Vestibular dysfunction affects over one third of the population over the age of 40 and a significant percentage of the younger population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Function Tests, Dizziness
- What is being tested?
- Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 22 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subject can speak and comprehend English.
- Subject can stand a strap placed on their head for an hour.
Who cannot join
- History of head injury within the last six months
- Presence of severe aphasia
- History of diagnosed neuropsychiatric disorders
- Documented neurodegenerative disorders
- Pregnancy [Female candidates will be asked if they are pregnant]
- History of Cerebrovascular disorders
- History of ear operation other than myringotomy and tube placement in the past
Trial locations and contacts
1 site in 1 country.
About this study
Vestibular disorders are among the most common causes of disability in society. Vestibular dysfunction affects over one third of the population over the age of 40 and a significant percentage of the younger population. Vestibular disorders have a dramatic impact on daily life impacting work, relationships, and even activities of daily living. Diagnosis of vestibular disorders is often facilitated by functional vestibular tests. The most common of these tests is videonystagmography, during a critical portion of which, the "caloric test," warm and cool stimuli are presented in the outer ears to stimulate the inner ear vestibular system. The vertigo produced by caloric stimulation not uncommonly results in nausea, and sometimes vomiting, sometimes to the point of not being able to complete the test protocol. In this project we examine a device that has shown promise and might be beneficial for improving the testing for vestibular disorders. We hypothesize that with this device, the nausea associated with caloric testing will be significantly reduced when the device is used, while it will not change the results of the test in a statistically significantly manner.
To date, the device has only been systematically tested on healthy volunteers.
Read the detailed description
Vestibular disorders can be difficult to diagnose and can vary in symptoms and fluctuate in severity. It is typically hard to determine which vestibular system (left/right) might be causing the vestibular disorder, as both sides normally work in unison. Testing the vestibular function in each side (left/right) of a patient is typically done with "caloric testing", which allows testing the left and right vestibular systems separately. However, it leads to nausea in most patients, and part of the clinical test is spent waiting for the patient to recover. Many patients undergoing caloric testing experience nausea to the point that some patients cannot complete the test, while others need a long period of time to recover from the nausea and dizziness induced by the testing. While it is hoped that this project will ultimately help establish the effectiveness of the transcranial vibration system for a range of vestibular disorders, we choose caloric testing for an initial assessment because it is performed daily in the clinic, it is easy to administer, and there is very little controversy about its use.
Specific Aims: Using Otolith Labs' device, we wish:
- To determine if subjects undergoing caloric testing treated with the device
- Experience less nausea than with no device, or
- If the subjects do experience nausea, whether the time to resolution is shorter with the device than with no device.
- To determine if the clinical results obtained by caloric testing are significantly different with the device compared to not wearing the device.
Objectives:
Primary: To demonstrate the efficacy of a bone conduction device at preventing nausea in subjects undergoing vestibular (particularly caloric) testing, as measured by the reduction from baseline of symptoms associated with (caloric)-testing
Secondary: To show that the use of the bone conduction device does not change the clinical measures obtained by vestibular caloric testing.
- Conditions
- Vestibular Function Tests, Dizziness
- Being tested
- Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing
- Keywords
- Caloric testing, vestibular nystagmography, VNG, Videonystagmography
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testingDevice
Transcranial vibrating system will be on then off (or off then on in a random order) during a repeated application of the "calorics testing" stimulus, i.e. warm or cold water irrigated in the left (then right) ear canal. The effect of the vibrating system on 1) resulting dizziness and nausea often experienced by patients and 2) clinical parameters measured by caloric testing will be quantified.
| Study group | Role | What they receive |
|---|---|---|
| Efficacy of vibrating system on healthy volunteers | Experimental | Not described Receives: Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing |
| Efficacy of vibrating system on vestibular patients | Experimental | Not described Receives: Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea and dizziness
Visual Analog Scales (VAS, adapted from "Visual Vertigo Analogue Scale" for dizziness and "Baxter Retching Faces (BARF)" for nausea) will be filled out by the subject ten minutes after each phase of the caloric testing, i.e. "with" and "without" the transcranial vibration system. Each phase of the caloric testing itself takes approximately 30 minutes. These Visual Analog Scales range from 0 to 10 (None to Agonizing). They will provide independent measures of the effectiveness of the transcranial vibration system.
Measured: VAS administered ten minutes post-caloric testing; data will be analyzed upon study completion, estimated to last 6 weeks
Secondary outcomes (1)
Vestibular testing outcomes
Nystagmus associated with caloric testing (the primary clinical measure derived from caloric testing) will be compared, in the "with device" and "without device" conditions.
Measured: Vestibular clinical measures will be analyzed by a clinician upon study completion, estimated to last 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Oct 2018
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular Function TestsStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- First phase: test 20 subjects. They will undergo the "caloric testing" part of the standard vestibular testing, with and without our transcranial vibration system (10 with device on then off, 10 with device off then on) and will describe their state on a "visual analog scale" (both dizziness and nausea) at the end. Success is 1) substantially reduced dizziness ad nausea, 2) statistically unchanged clinical measures. If (and only if) the first phase is successful, we proceed to the second phase. Second phase: identical to first phase, but is conducted with patients coming in the clinic for vestibular testing. The order ("device on" first, or second) will be randomly assigned.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otolith Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore
- Responsible party
- Sponsor
- Investigators
- David J Eisenman, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618199
- Sponsor's protocol ID
- Olith10101
- Status last verified
- Feb 2025
- First submitted
- 24 Jul 2018
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing
- ClinicalTrials.gov ID
- NCT03618199
- Acronym / sponsor ID
- Olith10101
- Conditions
- Vestibular Function Tests, Dizziness
- Keywords
- Caloric testing, vestibular nystagmography, VNG, Videonystagmography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Otolith LabsIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vestibular disorders are among the most common causes of disability in society. Vestibular dysfunction affects over one third of the population over the age of 40 and a significant percentage of the younger population. Vestibular disorders have a dramatic impact on daily life impacting work, relationships, and even activities of daily living. Diagnosis of vestibular disorders is often facilitated by functional vestibular tests. The most common of these tests is videonystagmography, during a critical portion of which, the "caloric test," warm and cool stimuli are presented in the outer ears to stimulate the inner ear vestibular system. The vertigo produced by caloric stimulation not uncommonly results in nausea, and sometimes vomiting, sometimes to the point of not being able to complete the test protocol. In this project we examine a device that has shown promise and might be beneficial for improving the testing for vestibular disorders. We hypothesize that with this device, the nausea associated with caloric testing will be significantly reduced when the device is used, while it will not change the results of the test in a statistically significantly manner.
To date, the device has only been systematically tested on healthy volunteers.
Detailed description
Vestibular disorders can be difficult to diagnose and can vary in symptoms and fluctuate in severity. It is typically hard to determine which vestibular system (left/right) might be causing the vestibular disorder, as both sides normally work in unison. Testing the vestibular function in each side (left/right) of a patient is typically done with "caloric testing", which allows testing the left and right vestibular systems separately. However, it leads to nausea in most patients, and part of the clinical test is spent waiting for the patient to recover. Many patients undergoing caloric testing experience nausea to the point that some patients cannot complete the test, while others need a long period of time to recover from the nausea and dizziness induced by the testing. While it is hoped that this project will ultimately help establish the effectiveness of the transcranial vibration system for a range of vestibular disorders, we choose caloric testing for an initial assessment because it is performed daily in the clinic, it is easy to administer, and there is very little controversy about its use.
Specific Aims: Using Otolith Labs' device, we wish:
- To determine if subjects undergoing caloric testing treated with the device
- Experience less nausea than with no device, or
- If the subjects do experience nausea, whether the time to resolution is shorter with the device than with no device.
- To determine if the clinical results obtained by caloric testing are significantly different with the device compared to not wearing the device.
Objectives:
Primary: To demonstrate the efficacy of a bone conduction device at preventing nausea in subjects undergoing vestibular (particularly caloric) testing, as measured by the reduction from baseline of symptoms associated with (caloric)-testing
Secondary: To show that the use of the bone conduction device does not change the clinical measures obtained by vestibular caloric testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- First phase: test 20 subjects. They will undergo the "caloric testing" part of the standard vestibular testing, with and without our transcranial vibration system (10 with device on then off, 10 with device off then on) and will describe their state on a "visual analog scale" (both dizziness and nausea) at the end. Success is 1) substantially reduced dizziness ad nausea, 2) statistically unchanged clinical measures. If (and only if) the first phase is successful, we proceed to the second phase. Second phase: identical to first phase, but is conducted with patients coming in the clinic for vestibular testing. The order ("device on" first, or second) will be randomly assigned.
| Arm | Type | Receives |
|---|---|---|
| Efficacy of vibrating system on healthy volunteers | Experimental | Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing |
| Efficacy of vibrating system on vestibular patients | Experimental | Device: Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject can speak and comprehend English.
- Subject can stand a strap placed on their head for an hour.
Key exclusion criteria (7 listed)
- History of head injury within the last six months
- Presence of severe aphasia
- History of diagnosed neuropsychiatric disorders
- Documented neurodegenerative disorders
- Pregnancy [Female candidates will be asked if they are pregnant]
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 |
|---|---|---|
| Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testingTranscranial vibrating system will be on then off (or off then on in a random order) during a repeated application of the "calorics testing" stimulus, i.e. warm or cold water irrigated in the left (then right) ear canal. The effect of the vibrating system on 1) resulting dizziness and nausea often experienced by patients and 2) clinical parameters measured by caloric testing will be quantified. | Device | Efficacy of vibrating system on healthy volunteers, Efficacy of vibrating system on vestibular patients |
Primary outcome
Nausea and dizziness
Time frame: VAS administered ten minutes post-caloric testing; data will be analyzed upon study completion, estimated to last 6 weeks
Visual Analog Scales (VAS, adapted from "Visual Vertigo Analogue Scale" for dizziness and "Baxter Retching Faces (BARF)" for nausea) will be filled out by the subject ten minutes after each phase of the caloric testing, i.e. "with" and "without" the transcranial vibration system. Each phase of the caloric testing itself takes approximately 30 minutes. These Visual Analog Scales range from 0 to 10 (None to Agonizing). They will provide independent measures of the effectiveness of the transcranial vibration system.
1 secondary outcome
Vestibular testing outcomes
Time frame: Vestibular clinical measures will be analyzed by a clinician upon study completion, estimated to last 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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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.
David J Eisenman, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing in people with Vestibular Function Tests and Dizziness, run by Otolith Labs 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 2 inclusion and 7 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 6 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nausea and dizziness (time frame: VAS administered ten minutes post-caloric testing; data will be analyzed upon study completion, estimated to last 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2025.