VertigoNCT04869020
Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting
A study testing Otoband in people with Vertigo, run by Otolith Labs at 1 site in United States.
Trial summary
This study seeks to gather data on the effect of a device, the OtoBand, in participants who have reported symptoms of vertigo, compared to the effect of using one of two sham devices. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vertigo
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 26 Nov 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
- Male or female subjects age 18 to 70 years old
- Vertigo that has been present for at least 90 days
- Vertigo that is constant or predictable
- Consulted a medical doctor in the past 24 months regarding their vertigo
- Identify as having vertigo from one of the following causes:
- Benign Paroxysmal Positional Vertigo (BPPV)
Show all 15Show fewer
- Meniere's Disease
- Vestibular Migraines
- Migraine Associated Vertigo
- Vestibular Neuritis
- Labyrinthitis
- Vertigo caused by COVID-19
- Score within appropriate range on the Dizziness Handicap Inventory
- Have a computer and access to internet for online video conferences
- PayPal, Venmo or Zelle account to receive compensation
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)
- Taking benzodiazepines (e.g., clonazepam, lorazepam, diazepam) for dizziness
- Vitreous detachment of the retina (floaters in the eye) in the previous 90 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Otolith Labs
Washington D.C., District of Columbia, 20009
About this study
This study seeks to gather data on the effect of a device, the OtoBand, in participants who have reported symptoms of vertigo, compared to the effect of using one of two sham devices. The study is designed to be conducted remotely using video conferencing between representatives of the manufacturer of the Otoband and participants. In order to comply with requirements for non-essential contact due to the Covid-19 pandemic there will be no person to person contact in the study.
Read the detailed description
In this phase of this pilot study, a minimum of 20 participants will be enrolled, with up to 100 participants maximum. This will provide adequately powered pilot data to measure effect size for the OtoBand and sham devices and to identify different causes of vertigo for which the OtoBand has a particularly strong effect as measured by the Otolith Vertigo Assessment Tool. After inclusion/exclusion screening and informed consent is obtained, potential participants will be assessed using the Dizziness Handicap Inventory (DHI). The DHI will be completed online.
Potential participants with a DHI score in the appropriate range will be accepted into the study. These participants will be asked to schedule an online meeting to with the study coordinator. In this online enrollment meeting, the study coordinator will review the Informed Consent and confirm other information supplied by the participant online (inclusion/exclusion) and then make an affirmative decision to enroll or not enroll participants in the study.
The participants will be randomly assigned to one of the two arms of the study (OtoBand / Sham Device A or OtoBand / Sham Device B). This is a blinded study in which every participant will be evaluated, and each participant may select the stimulation that best suits him or her on both of the study devices.
Each participant will select his/her preferred stimulation level by pressing the power level button on the study device; however, they will be blinded to which device they are using. Study participants will be asked to use the devices whenever they are having a symptom of vertigo. Each participant will be asked to record his/her level of vertigo in the online Study Diary: before putting on the device, after wearing the device for 5 minutes, after removing the device.
The study devices will record the following information regarding usage: Date and time when the device is turned on/off and the power level, Date and time when the power level is changed and the new power level.
Participants will be allowed to use the device as long as they are getting benefit from the device at any power setting that they select. Participants will be asked to complete an entry in the Study Diary even on days on which they do not experience a vertigo episode.
The study coordinator will schedule six study monitoring call with each participant as close as possible to the following schedule:
Call 1: Device I: 4 days after enrollment Call 2: Device I: 9 days after enrollment Call 3: Device I: 14 days after enrollment Call 4: Device II: 17 days after enrollment Call 5: Device II: 22 days after enrollment Call 6: Device II: 27 days after enrollment
- Conditions
- Vertigo
- Being tested
- Otoband, Sham A, Sham B
- Keywords
- BPPV, Meniere's disease, Migraine associated vertigo, Labyrinthitis, Vestibular neuritis
- Medical subject headings
- Vertigo, Meniere Disease, Labyrinthitis, Vestibular Neuronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtobandDevice
Participants with vertigo will wear the Otoband set at their chosen power level when experiencing symptoms.
Sham ADevice
Sham Device A is an OtoBand in which the transducer is modified so that the vibrations are not targeted at the vestibular system.
Sham BDevice
Sham Device B is an OtoBand that operates at power settings found to be nontherapeutic against vertigo associated with virtual reality.
| Study group | Role | What they receive |
|---|---|---|
| Otoband efficacy versus Sham A | Other | Participants in Arm 1 will receive, in random order, an OtoBand or Sham Device A to use for two weeks each. Sham Device A is an OtoBand in which the transducer is modified so that the vibrations do not target the vestibular system. There will be a two-day washout period between the devices. For the second two weeks, the participants will receive the alternate device (i.e., sham or effective). Receives: Device: Otoband; Device: Sham A |
| Otoband efficacy versus Sham B | Other | Participants in Arm 2 will receive, in random order, a OtoBand or Sham Device B. Sham Device B is an OtoBand that operates at settings found to be non-therapeutic in motion sickness studies. There will be a two-day washout period between the devices. For the second two weeks, the participants will receive the alternate device (i.e., sham, or effective). Receives: Device: Otoband; Device: Sham B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vertigo severity rating while wearing the OtoBand compared to the change in vertigo severity while wearing a sham device.
The primary endpoint will be the change in vertigo severity rating while wearing the OtoBand compared to the change vertigo severity while wearing the sham device during the worst, most intense episode of vertigo within each treatment period (sham versus OtoBand device).
Measured: Forms filled out daily over four week period by the study participant
Secondary outcomes (8)
Average change in vertigo severity rating while wearing the OtoBand compared to average change in vertigo severity while wearing the sham device.
This secondary outcome measure will be a statistically significant average improvement in reported vertigo when wearing the OtoBand, using the average change in reported vertigo when wearing the sham device as a reference.
Measured: Forms filled out daily over four week period by the study participant
Frequency of vertigo events during each period of testing (OtoBand versus sham).
We will compare the number of "definite vertigo days" during the study period, comparing the OtoBand period vs the sham period.
Measured: Forms filled out daily over four week period by the study participant
Durability of the effect over the observation period.
We will compare the mean change in reported vertigo during the first week vs the second week of use, for the period of OtoBand use and the period of sham device use. This will give an indication of whether any potential therapeutic effect of the devices remains constant over the duration of the study.
Measured: Forms filled out daily over four week period by the study participant
Complaints regarding usage.
We will classify complaints expressed during monitoring visits as "discomfort", "worsening" and those related to "efficacy", and model interactions between time and number of complaints, as a function of the testing group (OtoBand versus sham).
Measured: Information gathered in each monitoring visits over the four week period.
Relationship of the bone conduction stimulation level (in dB) selected by the participant to severity of reported vertigo.
We will evaluate any relationship between preferred bone conduction stimulation level and severity of vertigo episodes, by modelling interactions between time and (mean) bone conduction stimulation level selected by the participant for each vertigo episode, as a function of the testing group (OtoBand versus sham).
Measured: Forms filled out daily by the study participant over four week period compared to two data files captured by the devices over their two week usage.
Duration of use within each episode of vertigo and over the entire observation period.
We will evaluate any change in vertigo episode duration, by modelling interactions between time (day) and duration of device use per episode, as a function of the testing group (OtoBand versus sham).
Measured: Forms filled out daily over four week period by the study participant
Identification of a preferred dose.
We will measure the mean preferred power level per reported condition (BPPV, vestibulopathy, Meniere, Migraine associated vertigo) over all participants.
Measured: Data captured by the devices over the 14 days with each device.
Identification of the sham device with the smallest placebo effect.
We will measure any potential effectiveness of the sham devices, by comparing the mean change in vertigo score with the OtoBand and with the sham, for each of the two sham devices.
Measured: Forms filled out daily over 2 week period by the study participant with the sham in each arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start19 Apr 2021
- Primary completion27 Dec 2021
- Study completion26 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otolith Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Didier Depireux, Otolith Labs
- Investigators
- Didier Depireux, PhD, Principal investigator, OtolithLabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869020
- Sponsor's protocol ID
- Olith10701
- Status last verified
- Jul 2025
- First submitted
- 23 Apr 2021
- Last updated
- 17 Jul 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 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting
- ClinicalTrials.gov ID
- NCT04869020
- Acronym / sponsor ID
- Olith10701
- Conditions
- Vertigo
- Keywords
- BPPV, Meniere's disease, Migraine associated vertigo, Labyrinthitis, Vestibular neuritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Otolith LabsIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 26 Nov 2022 (actual)
- First posted
- 3 May 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.
This study seeks to gather data on the effect of a device, the OtoBand, in participants who have reported symptoms of vertigo, compared to the effect of using one of two sham devices. The study is designed to be conducted remotely using video conferencing between representatives of the manufacturer of the Otoband and participants. In order to comply with requirements for non-essential contact due to the Covid-19 pandemic there will be no person to person contact in the study.
Detailed description
In this phase of this pilot study, a minimum of 20 participants will be enrolled, with up to 100 participants maximum. This will provide adequately powered pilot data to measure effect size for the OtoBand and sham devices and to identify different causes of vertigo for which the OtoBand has a particularly strong effect as measured by the Otolith Vertigo Assessment Tool. After inclusion/exclusion screening and informed consent is obtained, potential participants will be assessed using the Dizziness Handicap Inventory (DHI). The DHI will be completed online.
Potential participants with a DHI score in the appropriate range will be accepted into the study. These participants will be asked to schedule an online meeting to with the study coordinator. In this online enrollment meeting, the study coordinator will review the Informed Consent and confirm other information supplied by the participant online (inclusion/exclusion) and then make an affirmative decision to enroll or not enroll participants in the study.
The participants will be randomly assigned to one of the two arms of the study (OtoBand / Sham Device A or OtoBand / Sham Device B). This is a blinded study in which every participant will be evaluated, and each participant may select the stimulation that best suits him or her on both of the study devices.
Each participant will select his/her preferred stimulation level by pressing the power level button on the study device; however, they will be blinded to which device they are using. Study participants will be asked to use the devices whenever they are having a symptom of vertigo. Each participant will be asked to record his/her level of vertigo in the online Study Diary: before putting on the device, after wearing the device for 5 minutes, after removing the device.
The study devices will record the following information regarding usage: Date and time when the device is turned on/off and the power level, Date and time when the power level is changed and the new power level.
Participants will be allowed to use the device as long as they are getting benefit from the device at any power setting that they select. Participants will be asked to complete an entry in the Study Diary even on days on which they do not experience a vertigo episode.
The study coordinator will schedule six study monitoring call with each participant as close as possible to the following schedule:
Call 1: Device I: 4 days after enrollment Call 2: Device I: 9 days after enrollment Call 3: Device I: 14 days after enrollment Call 4: Device II: 17 days after enrollment Call 5: Device II: 22 days after enrollment Call 6: Device II: 27 days after enrollment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Otoband efficacy versus Sham A | Other | Device: Otoband, Device: Sham AParticipants in Arm 1 will receive, in random order, an OtoBand or Sham Device A to use for two weeks each. Sham Device A is an OtoBand in which the transducer is modified so that the vibrations do not target the vestibular system. There will be a two-day washout period between the devices. For the second two weeks, the participants will receive the alternate device (i.e., sham or effective). |
| Otoband efficacy versus Sham B | Other | Device: Otoband, Device: Sham BParticipants in Arm 2 will receive, in random order, a OtoBand or Sham Device B. Sham Device B is an OtoBand that operates at settings found to be non-therapeutic in motion sickness studies. There will be a two-day washout period between the devices. For the second two weeks, the participants will receive the alternate device (i.e., sham, or effective). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female subjects age 18 to 70 years old
- Vertigo that has been present for at least 90 days
- Vertigo that is constant or predictable
- Consulted a medical doctor in the past 24 months regarding their vertigo
- Identify as having vertigo from one of the following causes:
Key exclusion criteria (5 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)
- Taking benzodiazepines (e.g., clonazepam, lorazepam, diazepam) for dizziness
- Vitreous detachment of the retina (floaters in the eye) in the previous 90 days
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 vertigo will wear the Otoband set at their chosen power level when experiencing symptoms. | Device | Otoband efficacy versus Sham A, Otoband efficacy versus Sham B |
| Sham ASham Device A is an OtoBand in which the transducer is modified so that the vibrations are not targeted at the vestibular system. | Device | Otoband efficacy versus Sham A |
| Sham BSham Device B is an OtoBand that operates at power settings found to be nontherapeutic against vertigo associated with virtual reality. | Device | Otoband efficacy versus Sham B |
Primary outcome
Change in vertigo severity rating while wearing the OtoBand compared to the change in vertigo severity while wearing a sham device.
Time frame: Forms filled out daily over four week period by the study participant
The primary endpoint will be the change in vertigo severity rating while wearing the OtoBand compared to the change vertigo severity while wearing the sham device during the worst, most intense episode of vertigo within each treatment period (sham versus OtoBand device).
8 secondary outcomes
Average change in vertigo severity rating while wearing the OtoBand compared to average change in vertigo severity while wearing the sham device.
Time frame: Forms filled out daily over four week period by the study participant
Frequency of vertigo events during each period of testing (OtoBand versus sham).
Time frame: Forms filled out daily over four week period by the study participant
Durability of the effect over the observation period.
Time frame: Forms filled out daily over four week period by the study participant
Complaints regarding usage.
Time frame: Information gathered in each monitoring visits over the four week period.
Relationship of the bone conduction stimulation level (in dB) selected by the participant to severity of reported vertigo.
Time frame: Forms filled out daily by the study participant over four week period compared to two data files captured by the devices over their two week usage.
Duration of use within each episode of vertigo and over the entire observation period.
Time frame: Forms filled out daily over four week period by the study participant
Identification of a preferred dose.
Time frame: Data captured by the devices over the 14 days with each device.
Identification of the sham device with the smallest placebo effect.
Time frame: Forms filled out daily over 2 week period by the study participant with the sham in each arm.
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 17 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Vertigo
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Recruiting
Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
Multiple Sclerosis
RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine
Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
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.
Didier Depireux, PhD principal investigator
OtolithLabs
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 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 15 inclusion and 5 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 Jul 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?
Change in vertigo severity rating while wearing the OtoBand compared to the change in vertigo severity while wearing a sham device. (time frame: Forms filled out daily over four week period by the study participant). 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 17 Jul 2025.