Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in… (NCT04869020) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting
United States40 participantsStarted 2021-04-19
Plain-language summary
This study seeks to gather data on the effect of a device, the OtoBand, in participants who have reported symptoms of vertigo, compared to the effect of using one of two sham devices. The study is designed to be conducted remotely using video conferencing between representatives of the manufacturer of the Otoband and participants. In order to comply with requirements for non-essential contact due to the Covid-19 pandemic there will be no person to person contact in the study.
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:
* Male or female subjects age 18 to 70 years old
* Vertigo that has been present for at least 90 days
* Vertigo that is constant or predictable
* Consulted a medical doctor in the past 24 months regarding their vertigo
* Identify as having vertigo from one of the following causes:
* Benign Paroxysmal Positional Vertigo (BPPV)
* Meniere's Disease
* Vestibular Migraines
* Migraine Associated Vertigo
* Vestibular Neuritis
* Labyrinthitis
* Vertigo caused by COVID-19
* Score within appropriate range on the Dizziness Handicap Inventory
* Have a computer and access to internet for online video conferences
* PayPal, Venmo or Zelle account to receive compensation
Exclusion Criteria:
* Vertigo that first presented within the last 90 days
* Skull base surgery within the last 90 days
* Any skull implant (cochlear implant, bone conduction implant, DBS)
* Taking benzodiazepines (e.g., clonazepam, lorazepam, diazepam) for dizziness
* Vitreous detachment of the retina (floaters in the eye) in the previous 90 days
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
1
Change in vertigo severity rating while wearing the OtoBand compared to the change in vertigo severity while wearing a sham device.
Timeframe: Forms filled out daily over four week period by the study participant