Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand
Vertigo, BPPV, Meniere Disease
About this trial
This is an interventional treatment trial for Vertigo
Eligibility Criteria
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.
Sites / Locations
- Otolith LabsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Sham Comparator
Experimental
Sham Comparator
1. Moderate or Worse (MoW) Arm
2. Moderate or Worse (MoW) Arm
1. Quality of Life (QoL) Arm
2. Quality of Life (QoL) Arm
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.
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.
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.
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.