CompletedNot Applicable

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

United States109 participantsStarted 2023-02-02

Plain-language 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. 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 rehabili…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Moderate or Worse Change in Vertigo Severity

Timeframe: Through 21 days of treatment phase of "moderate of worse" arm of study

Quality of Life Change in Scores

Timeframe: Day 28 of treatment phase of "quality of life" arm of study

Trial details

NCT IDNCT05960786

SponsorOtolith Labs

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-07

View on ClinicalTrials.gov More Vertigo trials