DizzinessNCT05157399
Quantification of the Effect of the OtoBand on Objective Measures of Vertigo and Dizziness
A study testing Otoband in people with Dizziness and Vertigo, run by Otolith Labs at 1 site in United States.
Trial summary
Vestibular disorders are among the most common causes of disability in society and affect over 50% of the population over the age of 65 and a significant percentage of the younger population. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dizziness, Vertigo, Vestibular Migraine
- What is being tested?
- Otoband
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2021to 1 Sep 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vertigo that has been present for at least 90 days, constant or predictable with attacks at least twice a week.
- Classified as having vertigo from one of the following vestibulogenic vertigo conditions:
- Migraine Associated Vertigo, aka Vestibular Migraine
- Chronic Unilateral Vestibulopathy in one of three forms: Persistent Postural-Perceptual Dizziness (aka 3PD), Vestibular Neuritis, Labyrinthitis
- Score > 35 on Dizziness Handicap Inventory
- Willingness to cease vestibular suppressants for 24h prior to study.
Who cannot join
- Vertigo that first presented within the last 90 days
- Skull base surgery within the last 90 days
- Any skull implant (cochlear implant, bone conduction implant, DBS)
- Resolved vestibular dysfunction by the time of study appointment
- History of head injury within the last 6 months or currently suffering the effects of a head injury
- History of diagnosed untreated neuropsychiatric disorders (hypochondriasis, major depression, schizophrenia)
Show all 13Show fewer
- Prior documented neurodegenerative disorders of hearing and balance including:
- Multiple sclerosis
- Vestibular schwannoma
- History of Cerebrovascular disorders
- History of ear operation other than myringotomy (tube placement)
- Vitreous detachment of the retina (floaters) in the previous 90 days
- Presence of severe aphasia, and individuals who cannot provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Dizzy and Vertigo Institute of Los Angeles
Los Angeles, California, 90048
About this study
Official title: Quantification of the Effect of the OtoBand, a Non-invasive Vestibular Masker, on Objective Measures of Vertigo and Dizziness
Vestibular disorders are among the most common causes of disability in society and affect over 50% of the population over the age of 65 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.The OtoBand has shown promise and might be beneficial for treating or improving the course of recovery from vestibular disorders.
This study seeks to quantify the effect of the study device, the OtoBand, on objective measures of dizziness and vertigo in patients with vestibular dysfunction.
The study will be conducted at a single-site and will be a blinded, randomized, placebo-controlled design in which participants do not know if they are receiving bone conducted stimulation 1) at a therapeutic level or 2) at a non therapeutic level.
Read the detailed description
Vestibular disorders are among the most common causes of disability in society and affect over 50% of the population over the age of 65 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. At the current time, the mainstay of therapy for many vestibular disorders is a physical therapy called vestibular rehabilitation. While usually highly effective, this therapy is time consuming and not universally effective, in part because of inconsistent subject compliance. The use of adjuvant devices to speed recovery has been studied but very few devices have proved beneficial; the few that have shown benefit only work in special populations and are large units that cost several million dollars.
In this study, the investigators will assay the efficacy of the OtoBand in participants with vertigo and dizziness. The OtoBand will be given to participants with vertigo and dizziness in patients with vestibular dysfunction. Participants will be recruited from patients who present at the Dizziness and Vertigo Institute of Los Angeles and for whom the Principal Investigators recommend a course of vestibular rehabilitation therapy. The OtoBand will be set at either a normal power (effective) or low power (lower than the power level thought to be effective, placebo device). Participants will not know if they are receiving receiving bone conducted stimulation 1) at a therapeutic level or 2) at a non therapeutic level.
This study seeks to determine if, in patients going to the Dizzy and Vertigo Institute of Los Angeles for vestibular rehabilitation therapy, objective measures of dizziness and vertigo are significantly changed by wearing the OtoBand.
Potential changes will be measured in the following tests:
- Subjective Visual Vertical (SVV),
- Sinusoidal Harmonic Acceleration (SHA), also known as rotary chair test
- Spontaneous Nystagmus
In this current protocol, three conditions (sham, therapeutic and no device) will be tested within an hour in a randomized sequence, with the OtoBand remaining in place throughout (turned off in the "no device" condition).
The primary endpoint of the study is to determine the change(s) induced by the OtoBand in objective measures of vestibular symptoms.
The secondary endpoints of the study include:
- Participant's questionnaire as to which level the participant believes they used first and second (sham setting vs therapeutic setting);
- Measure whether Migraine and Vestibulopathy patients experience higher benefits from a given power level as measured by objective tests (SVV, SHAs and spontaneous nystagmus);
- Measure whether Migraine and Vestibulopathy patients experience any benefit from the placebo setting.
- Conditions
- Dizziness, Vertigo, Vestibular Migraine, Vestibular Neuritis, Labyrinthitis
- Being tested
- Otoband, Placebo Device
- Keywords
- Vestibular weakness
- Medical subject headings
- Dizziness, Vertigo, Vestibular Neuronitis, Labyrinthitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtobandDevice
Participants with Dizziness and Vertigo will wear the Otoband set at normal power (effective) during vestibular test battery and outcome measurements will be recorded by the investigator during site visit.
Placebo DeviceDevice
Participants with Dizziness and Vertigo will wear the placebo device set at low power during vestibular test battery and outcome measurements will be recorded by the investigator during site visit.
| Study group | Role | What they receive |
|---|---|---|
| OtoBand Efficacy on Vertigo and Dizziness | Experimental | During the single site visit, participants will wear the Otoband, on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. OtoBand will be set to 92dB or 98dB bone conduction level (Re: 1 Dyne). The participants will be fitted with the Otoband and will undergo the vestibular battery test. The investigator will record the outcome measurements. Receives: Device: Otoband |
| Placebo Device Efficacy on Vertigo and Dizziness | Placebo comparator | Participants will wear the Otoband, on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. OtoBand set to a bone conduction level 10dB lower than the level used in the experimental condition. Once fitted with the Otoband, participants will undergo the vestibular battery test. The investigator will record the outcome measurements. Receives: Device: Placebo Device |
| No Device | No intervention | Participants will wear the OtoBand, but turned off, to collect baseline data. This will be randomized. The participants will be fitted with the Otoband and will undergo the vestibular battery test. The investigator will record the outcome measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine change in objective measures of vestibular symptoms, namely change in VOR Gain induced by the OtoBand.
We measure the Gain of the Vestibular Ocular Reflex (VOR) associated with sinusoidal harmonic accelerations (SHAs) at multiple frequencies of rotation. The mean Gain across all frequencies will be computed for each three experimental conditions (OtoBand/sham/no device). The quantifiable outcome will be the deviation from nominal values of the Gain as a function of experimental condition.
Measured: Within 60 minute trial period.
Determine change in objective measures of vestibular symptoms, namely change in VOR Phase induced by the OtoBand.
We measure the Phase of the Vestibular Ocular Reflex (VOR) associated with sinusoidal harmonic accelerations (SHAs) at multiple frequencies of rotation. The mean phase lag across all frequencies will be computed for each three experimental conditions (OtoBand/sham/no device). The quantifiable outcome will be the deviation from nominal values of the phase lag as a function of experimental condition.
Measured: Within 60 minute trial period.
Secondary outcomes (3)
Participant's questionnaire as to which power level they believe were sham setting vs therapeutic setting
Compare participants' estimation of which device provided the most benefits, to the improvement in VOR gain measured during sinusoidal harmonic accelerations (SHAs).
Measured: Within 60 minute trial period.
Measure whether Vestibular Migraine and Vestibulopathy patients experience higher benefits from a low vs high bone conduction levels as measured by outcomes of objective tests (SHAs and spontaneous nystagmus)
Measure statistically significant changes in VOR gain as measured from Sinusoidal Harmonic Accelerations (SHAs) and spontaneous nystagmus, as a function of the OtoBand's power level and as a function of the participant's condition (vestibular migraine vs vestibulopathy)
Measured: Within 60 minute trial period.
Determine change in objective measures of vestibular symptoms, namely change in residual nystagmus following SHAs, as a function of experimental condition.
Following sinusoidal harmonic accelerations (SHAs) in the rotary chair, we measure residual eye movements (nystagmus) for one minute at rest. The amplitude and frequency of these eye movements will be computed for each three experimental conditions (OtoBand/sham/no device). The quantifiable outcome will be the deviation from nominal values of the nystagmus as a function of experimental condition.
Measured: Within 60 minute trial period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start4 Nov 2021
- Primary completion9 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otolith Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dizzy and Vertigo Institute of Los Angeles
- Responsible party
- Sponsor
- Investigators
- Brooke Pearce, AuD, Principal investigator, Dizzy and Vertigo Institute of Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157399
- Sponsor's protocol ID
- OLith10302
- Status last verified
- Nov 2022
- First submitted
- 24 Nov 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of the Effect of the OtoBand, a Non-invasive Vestibular Masker, on Objective Measures of Vertigo and Dizziness
- ClinicalTrials.gov ID
- NCT05157399
- Acronym / sponsor ID
- OLith10302
- Conditions
- Dizziness, Vertigo, Vestibular Migraine, Vestibular Neuritis, Labyrinthitis
- Keywords
- Vestibular weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Otolith LabsIndustry (pharma, biotech, devices)
- Collaborators
- Dizzy and Vertigo Institute of Los Angeles
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 15 Dec 2021 (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 and affect over 50% of the population over the age of 65 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.The OtoBand has shown promise and might be beneficial for treating or improving the course of recovery from vestibular disorders.
This study seeks to quantify the effect of the study device, the OtoBand, on objective measures of dizziness and vertigo in patients with vestibular dysfunction.
The study will be conducted at a single-site and will be a blinded, randomized, placebo-controlled design in which participants do not know if they are receiving bone conducted stimulation 1) at a therapeutic level or 2) at a non therapeutic level.
Detailed description
Vestibular disorders are among the most common causes of disability in society and affect over 50% of the population over the age of 65 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. At the current time, the mainstay of therapy for many vestibular disorders is a physical therapy called vestibular rehabilitation. While usually highly effective, this therapy is time consuming and not universally effective, in part because of inconsistent subject compliance. The use of adjuvant devices to speed recovery has been studied but very few devices have proved beneficial; the few that have shown benefit only work in special populations and are large units that cost several million dollars.
In this study, the investigators will assay the efficacy of the OtoBand in participants with vertigo and dizziness. The OtoBand will be given to participants with vertigo and dizziness in patients with vestibular dysfunction. Participants will be recruited from patients who present at the Dizziness and Vertigo Institute of Los Angeles and for whom the Principal Investigators recommend a course of vestibular rehabilitation therapy. The OtoBand will be set at either a normal power (effective) or low power (lower than the power level thought to be effective, placebo device). Participants will not know if they are receiving receiving bone conducted stimulation 1) at a therapeutic level or 2) at a non therapeutic level.
This study seeks to determine if, in patients going to the Dizzy and Vertigo Institute of Los Angeles for vestibular rehabilitation therapy, objective measures of dizziness and vertigo are significantly changed by wearing the OtoBand.
Potential changes will be measured in the following tests:
- Subjective Visual Vertical (SVV),
- Sinusoidal Harmonic Acceleration (SHA), also known as rotary chair test
- Spontaneous Nystagmus
In this current protocol, three conditions (sham, therapeutic and no device) will be tested within an hour in a randomized sequence, with the OtoBand remaining in place throughout (turned off in the "no device" condition).
The primary endpoint of the study is to determine the change(s) induced by the OtoBand in objective measures of vestibular symptoms.
The secondary endpoints of the study include:
- Participant's questionnaire as to which level the participant believes they used first and second (sham setting vs therapeutic setting);
- Measure whether Migraine and Vestibulopathy patients experience higher benefits from a given power level as measured by objective tests (SVV, SHAs and spontaneous nystagmus);
- Measure whether Migraine and Vestibulopathy patients experience any benefit from the placebo setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OtoBand Efficacy on Vertigo and Dizziness | Experimental | Device: OtobandDuring the single site visit, participants will wear the Otoband, on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. OtoBand will be set to 92dB or 98dB bone conduction level (Re: 1 Dyne). The participants will be fitted with the Otoband and will undergo the vestibular battery test. The investigator will record the outcome measurements. |
| Placebo Device Efficacy on Vertigo and Dizziness | Placebo comparator | Device: Placebo DeviceParticipants will wear the Otoband, on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. OtoBand set to a bone conduction level 10dB lower than the level used in the experimental condition. Once fitted with the Otoband, participants will undergo the vestibular battery test. The investigator will record the outcome measurements. |
| No Device | No intervention | –Participants will wear the OtoBand, but turned off, to collect baseline data. This will be randomized. The participants will be fitted with the Otoband and will undergo the vestibular battery test. The investigator will record the outcome measurements. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Vertigo that has been present for at least 90 days, constant or predictable with attacks at least twice a week.
- Classified as having vertigo from one of the following vestibulogenic vertigo conditions:
- Score > 35 on Dizziness Handicap Inventory
- Willingness to cease vestibular suppressants for 24h prior to study.
Key exclusion criteria (13 listed)
- Vertigo that first presented within the last 90 days
- Skull base surgery within the last 90 days
- Any skull implant (cochlear implant, bone conduction implant, DBS)
- Resolved vestibular dysfunction by the time of study appointment
- History of head injury within the last 6 months or currently suffering the effects of a head injury
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 |
|---|---|---|
| OtobandParticipants with Dizziness and Vertigo will wear the Otoband set at normal power (effective) during vestibular test battery and outcome measurements will be recorded by the investigator during site visit. | Device | OtoBand Efficacy on Vertigo and Dizziness |
| Placebo DeviceParticipants with Dizziness and Vertigo will wear the placebo device set at low power during vestibular test battery and outcome measurements will be recorded by the investigator during site visit. | Device | Placebo Device Efficacy on Vertigo and Dizziness |
Primary outcome
Determine change in objective measures of vestibular symptoms, namely change in VOR Gain induced by the OtoBand.
Time frame: Within 60 minute trial period.
We measure the Gain of the Vestibular Ocular Reflex (VOR) associated with sinusoidal harmonic accelerations (SHAs) at multiple frequencies of rotation. The mean Gain across all frequencies will be computed for each three experimental conditions (OtoBand/sham/no device). The quantifiable outcome will be the deviation from nominal values of the Gain as a function of experimental condition.
Determine change in objective measures of vestibular symptoms, namely change in VOR Phase induced by the OtoBand.
Time frame: Within 60 minute trial period.
We measure the Phase of the Vestibular Ocular Reflex (VOR) associated with sinusoidal harmonic accelerations (SHAs) at multiple frequencies of rotation. The mean phase lag across all frequencies will be computed for each three experimental conditions (OtoBand/sham/no device). The quantifiable outcome will be the deviation from nominal values of the phase lag as a function of experimental condition.
3 secondary outcomes
Participant's questionnaire as to which power level they believe were sham setting vs therapeutic setting
Time frame: Within 60 minute trial period.
Measure whether Vestibular Migraine and Vestibulopathy patients experience higher benefits from a low vs high bone conduction levels as measured by outcomes of objective tests (SHAs and spontaneous nystagmus)
Time frame: Within 60 minute trial period.
Determine change in objective measures of vestibular symptoms, namely change in residual nystagmus following SHAs, as a function of experimental condition.
Time frame: Within 60 minute trial period.
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 15 Nov 2022.
- 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.
Brooke Pearce, AuD principal investigator
Dizzy and Vertigo Institute of Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otoband in people with Dizziness and Vertigo, 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 6 inclusion and 13 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 15 Nov 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. Some participants in this study may receive a placebo. 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?
Determine change in objective measures of vestibular symptoms, namely change in VOR Gain induced by the OtoBand. (time frame: Within 60 minute trial period.). The study lists 2 primary outcomes in all. 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 15 Nov 2022.