NCT05960786Completed
Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand
Source: ClinicalTrials.gov · Last updated 20 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 109 (actual)
- First submitted
- 18 May 2023
- Start date
- 2 Feb 2023
- Primary completion date
- 7 Dec 2023
- Lead sponsor
- Otolith Labs
- Diseases
- Migraine
- NCT number
- NCT05960786
What you commit to
- Study type: Interventional
- Participants enrolled: 109
- From 2 Feb 2023 to the primary completion date, 7 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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)
Other illness
- History of vitreous detachment (aka floaters) in the last 90 days
- Hyperacusis (aka hypersensitivity to loud sounds)
- History of cerebrovascular disorders
Other
- Superior canal dehiscence (aka third window) or otic capsule dehiscence
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Otolith Labs Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.