Vertigo Clinical Trial
Official title:
Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand
Verified date | February 2024 |
Source | Otolith Labs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 109 |
Est. completion date | December 7, 2023 |
Est. primary completion date | December 7, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Otolith Labs | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Otolith Labs | MCRA |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Effectiveness of Rating Scales | Comparison of Verbal Rating Scale vs. Numerical Rating Scale as representation of participant response to device treatment. | Through 21 days of treatment phase of "moderate of worse" arm of study | |
Primary | 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 | |
Primary | 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 | 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 |
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