Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand

Study Overview
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Brief Summary
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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 vertigo. The main question[s] it aims to answer are: Which device do participants respond better to (that is, find more relief)? To what degree do participants find relief? 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
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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 MoW arm have completed the study, and until 72 participants have completed the 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 21, Day 24, Day 31, and Day 42 QoL Group : Day 16, Day, 24, Day 36, 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

Official Title
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Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand

Conditions
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Vertigo, BPPV, Meniere Disease, Labrynthitis, Vestibular Disorder, Vestibular Migraine, Benign Paroxysmal Positional Vertigo, Ménière's Vertigo

Intervention / Treatment
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* Device: Otoband Experimental
* Device: Otoband Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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. Exclusion Criteria: 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) 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Moderate or Worse (MoW) Arm<br>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. | Device: Otoband Experimental<br>* Participants will be randomly assigned to use the Otoband to determine effectiveness in providing temporary relief to symptoms of vertigo.<br>|
| Sham Comparator: 2. Moderate or Worse (MoW) Arm<br>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. | Device: Otoband Sham<br>* Participants will be randomly assigned to use the Otoband sham to determine effectiveness in providing temporary relief to symptoms of vertigo.<br>|
| Experimental: 1. Quality of Life (QoL) Arm<br>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. | Device: Otoband Experimental<br>* Participants will be randomly assigned to use the Otoband to determine effectiveness in providing temporary relief to symptoms of vertigo.<br>|
| Sham Comparator: 2. Quality of Life (QoL) Arm<br>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. | Device: Otoband Sham<br>* Participants will be randomly assigned to use the Otoband sham to determine effectiveness in providing temporary relief to symptoms of vertigo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Day 28 of treatment phase of quality of life arm of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Effectiveness | Percent change in mean severity of vertigo episodes as reported by the participant during the Treatment phase, compared to the Baseline phase. | 30 minutes post vertigo episode during the treatment phase |