VertigoNCT05960786
Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand
A study testing Otoband Experimental in people with Vertigo and BPPV, run by Otolith Labs at 1 site in United States.
Trial summary
The goal of this virtual clinical trial is to determine the effectiveness of two study devices in providing temporary relief to adults aged 18-70 who suffer from symptoms of chronic vestibular vertigo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vertigo, BPPV, Meniere Disease
- What is being tested?
- Otoband Experimental
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2023to 7 Dec 2023
- 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
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Diagnosed as having vestibular vertigo that is caused by one or more of:
- Benign paroxysmal positional vertigo (BPPV)
- Migraine associated vertigo (MAV, aka vertiginous migraines)
- Meniere's disease (aka idiopathic endolymphatic hydrops)
- Uncompensated unilateral vestibulopathy (such as arising from vestibular neuritis and labyrinthitis)
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- Vertigo that has been present for at least 90 days
- Score greater than 35, and less than 91, on the Dizziness Handicap Inventory (corresponding to moderate to severe vertigo)
- Smartphone, computer or tablet and access to internet for online enrollment, check-in and wrap-up meetings
- Willingness to install and use the JotForm ePRO app
- Residing in the United States
- Willingness to be paid via Venmo or PayPal.
Who cannot join
- Surgery to the base of the skull within the last 6 months or plans for surgery to the skull during enrollment period
- Any skull or neck implants such as but not limited to a cochlear implant, vascular stents, bone conduction implant, or deep brain stimulation device
- History of vitreous detachment (aka floaters) in the last 90 days
- Superior canal dehiscence (aka third window) or otic capsule dehiscence
- Hyperacusis (aka hypersensitivity to loud sounds)
- Currently undergoing vestibular rehabilitation therapy or planning to start vestibular rehabilitation therapy during the study. (People who have completed vestibular rehabilitation therapy, but in whom vestibular vertigo persists, will be permitted to enroll)
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- History of cerebrovascular disorders
- Posterior fossa tumors (brain tumors located in the caudal third of the skull)
- Vestibular schwannoma (non-cancerous tumor located on the vestibulo-cochlear nerve)
- Cerebellar degeneration (progressive worsening of neurons behind the brain stem)
- Taking benzodiazepines (e.g., clonazepam, lorazepam, diazepam) for vestibular issues.
Trial locations and contacts
1 site in 1 country.
United States1 site
Otolith Labs
Washington D.C., District of Columbia, 20001
About this study
The goal of this virtual clinical trial is to determine the effectiveness of two study devices in providing temporary relief to adults aged 18-70 who suffer from symptoms of chronic vestibular vertigo.
The main question[s] it aims to answer are:
Read more
- Within an episode, is there a significant difference between the randomized study devices at the individual timepoints during the vertigo episode?
- Within an episode, is there evidence of quantitative treatment at each individual timepoint during the vertigo episode?
Participants will be:
- Enrolled up to 49 days; 14 days in Baseline Phase (no device) and 21 days in Treatment Phase (study device) for Study Arm 1 or 28 days in Treatment Phase (study device) for Study Arm 2
- Randomized and stratified into groups based on diagnosis to be assigned a study device
- Asked to use the study device as instructed by the study coordinator
- Asked to download a study app to submit daily diaries regarding their symptoms and use of device, and to participate in tele-health visits with study coordinators
- Asked to provide their vertigo diagnosis from their physician
- Compensated for their participation
Researchers will compare the randomized groups to see which groups respond better to which device.
Read the detailed description
This study is decentralized clinical trial. This study uses technology and and virtual meetings to communicate with study participants and collect study data. This study seeks to enroll until 36 participants in the Moderate or Worse (MoW) arm have completed the study, and until 72 participants have completed the Quality of Life (QoL) arm.
All study participants that meet all of the inclusion, none of the exclusion criteria, and sign informed consent will be enrolled in the study. Participants will complete a one day enrollment meeting and an approximately 14 day Baseline Phase.
After the Baseline Phase, participants will be placed in one of two groups Moderate or Worse (MoW) group or Quality of Life (QoL) group based on the data collected about their vertigo during the Baseline Phase.
Participants will then be randomized within their assigned group (MoW or QoL) at a 2:1 ratio to an active arm or sham arm to begin the Treatment Phase of the study. Participants will be sent a study device to use when they have a vertigo episode.
Participants that enroll in the study are expected to participate up to 49 days with virtual meetings at the approximate intervals:
MoW Group: Day 4, Day 16, Day 21, Day 24, Day 31, and Day 42 QoL Group : Day 4, Day 16, Day, 21, Day 24, Day 31, and Day 49
Participants will be required to complete the DHI (Dizziness Handicap Index), VSS (Vertigo Symptom Scale), Global Impression of Symptoms, and Global Impression of Change questionnaires.
Otolith Labs received Therapeutic Breakthrough Device designation by the FDA in May 2021.
- Conditions
- Vertigo, BPPV, Meniere Disease, Labrynthitis, Vestibular Disorder, Vestibular Migraine
- Being tested
- Otoband Experimental, Otoband Sham
- Medical subject headings
- Vertigo, Meniere Disease, Vestibular Diseases, Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otoband ExperimentalDevice
Participants will be randomly assigned to use the Otoband to determine effectiveness in providing temporary relief to symptoms of vertigo.
Otoband ShamDevice
Participants will be randomly assigned to use the Otoband sham to determine effectiveness in providing temporary relief to symptoms of vertigo.
| Study group | Role | What they receive |
|---|---|---|
| 1. Moderate or Worse (MoW) Arm | Experimental | Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the experimental device. Receives: Device: Otoband Experimental |
| 2. Moderate or Worse (MoW) Arm | Sham comparator | Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the sham device. Receives: Device: Otoband Sham |
| 1. Quality of Life (QoL) Arm | Experimental | Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the experimental device. Receives: Device: Otoband Experimental |
| 2. Quality of Life (QoL) Arm | Sham comparator | Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the sham device. Receives: Device: Otoband Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate or Worse Change in Vertigo Severity
Change in participant response to "How severe is your vertigo right now?" during vertigo episodes, compared to responses in baseline phase
Measured: Through 21 days of treatment phase of "moderate of worse" arm of study
Quality of Life Change in Scores
Change in participant's Vertigo Symptom Scale (VSS) score, compared to baseline VSS score
Measured: Day 28 of treatment phase of "quality of life" arm of study
Secondary outcomes (1)
Device Effectiveness
Percent change in mean severity of vertigo episodes as reported by the participant during the Treatment phase, compared to the Baseline phase.
Measured: 30 minutes post vertigo episode during the treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start2 Feb 2023
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otolith Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
- Investigators
- Didier Depireux, PhD, Principal investigator, Otolith Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960786
- Sponsor's protocol ID
- OLith10702
- Status last verified
- Mar 2025
- First submitted
- 18 May 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand
- ClinicalTrials.gov ID
- NCT05960786
- Acronym / sponsor ID
- OLith10702
- Conditions
- Vertigo, BPPV, Meniere Disease, Labrynthitis, Vestibular Disorder, Vestibular Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Otolith LabsIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 27 Jul 2023 (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.
The goal of this virtual clinical trial is to determine the effectiveness of two study devices in providing temporary relief to adults aged 18-70 who suffer from symptoms of chronic vestibular vertigo.
The main question[s] it aims to answer are:
- Within an episode, is there a significant difference between the randomized study devices at the individual timepoints during the vertigo episode?
- Within an episode, is there evidence of quantitative treatment at each individual timepoint during the vertigo episode?
Participants will be:
- Enrolled up to 49 days; 14 days in Baseline Phase (no device) and 21 days in Treatment Phase (study device) for Study Arm 1 or 28 days in Treatment Phase (study device) for Study Arm 2
- Randomized and stratified into groups based on diagnosis to be assigned a study device
- Asked to use the study device as instructed by the study coordinator
- Asked to download a study app to submit daily diaries regarding their symptoms and use of device, and to participate in tele-health visits with study coordinators
- Asked to provide their vertigo diagnosis from their physician
- Compensated for their participation
Researchers will compare the randomized groups to see which groups respond better to which device.
Detailed description
This study is decentralized clinical trial. This study uses technology and and virtual meetings to communicate with study participants and collect study data. This study seeks to enroll until 36 participants in the Moderate or Worse (MoW) arm have completed the study, and until 72 participants have completed the Quality of Life (QoL) arm.
All study participants that meet all of the inclusion, none of the exclusion criteria, and sign informed consent will be enrolled in the study. Participants will complete a one day enrollment meeting and an approximately 14 day Baseline Phase.
After the Baseline Phase, participants will be placed in one of two groups Moderate or Worse (MoW) group or Quality of Life (QoL) group based on the data collected about their vertigo during the Baseline Phase.
Participants will then be randomized within their assigned group (MoW or QoL) at a 2:1 ratio to an active arm or sham arm to begin the Treatment Phase of the study. Participants will be sent a study device to use when they have a vertigo episode.
Participants that enroll in the study are expected to participate up to 49 days with virtual meetings at the approximate intervals:
MoW Group: Day 4, Day 16, Day 21, Day 24, Day 31, and Day 42 QoL Group : Day 4, Day 16, Day, 21, Day 24, Day 31, and Day 49
Participants will be required to complete the DHI (Dizziness Handicap Index), VSS (Vertigo Symptom Scale), Global Impression of Symptoms, and Global Impression of Change questionnaires.
Otolith Labs received Therapeutic Breakthrough Device designation by the FDA in May 2021.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. Moderate or Worse (MoW) Arm | Experimental | Device: Otoband ExperimentalParticipants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the experimental device. |
| 2. Moderate or Worse (MoW) Arm | Sham comparator | Device: Otoband ShamParticipants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the sham device. |
| 1. Quality of Life (QoL) Arm | Experimental | Device: Otoband ExperimentalParticipants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the experimental device. |
| 2. Quality of Life (QoL) Arm | Sham comparator | Device: Otoband ShamParticipants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the sham device. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- To be eligible to participate in this study, an individual must meet all the following criteria:
Key exclusion criteria (11 listed)
- Surgery to the base of the skull within the last 6 months or plans for surgery to the skull during enrollment period
- Any skull or neck implants such as but not limited to a cochlear implant, vascular stents, bone conduction implant, or deep brain stimulation device
- History of vitreous detachment (aka floaters) in the last 90 days
- Superior canal dehiscence (aka third window) or otic capsule dehiscence
- Hyperacusis (aka hypersensitivity to loud sounds)
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 |
|---|---|---|
| Otoband ExperimentalParticipants will be randomly assigned to use the Otoband to determine effectiveness in providing temporary relief to symptoms of vertigo. | Device | 1. Moderate or Worse (MoW) Arm, 1. Quality of Life (QoL) Arm |
| Otoband ShamParticipants will be randomly assigned to use the Otoband sham to determine effectiveness in providing temporary relief to symptoms of vertigo. | Device | 2. Moderate or Worse (MoW) Arm, 2. Quality of Life (QoL) Arm |
Primary outcome
Moderate or Worse Change in Vertigo Severity
Time frame: Through 21 days of treatment phase of "moderate of worse" arm of study
Change in participant response to "How severe is your vertigo right now?" during vertigo episodes, compared to responses in baseline phase
Quality of Life Change in Scores
Time frame: Day 28 of treatment phase of "quality of life" arm of study
Change in participant's Vertigo Symptom Scale (VSS) score, compared to baseline VSS score
1 secondary outcome
Device Effectiveness
Time frame: 30 minutes post vertigo episode during the treatment phase
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 20 Mar 2025.
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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.
Didier Depireux, PhD principal investigator
Otolith Labs
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 Experimental in people with Vertigo and BPPV, 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 12 inclusion and 11 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 20 Mar 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. 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?
Moderate or Worse Change in Vertigo Severity (time frame: Through 21 days of treatment phase of "moderate of worse" arm of study). 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 20 Mar 2025.