Status:
COMPLETED
Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting
Lead Sponsor:
Otolith Labs
Conditions:
Vertigo
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 des...
Detailed Description
In this phase of this pilot study, a minimum of 20 participants will be enrolled, with up to 100 participants maximum. This will provide adequately powered pilot data to measure effect size for the Ot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04869020
Start Date
April 19 2021
End Date
November 26 2022
Last Update
July 17 2025
Active Locations (1)
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1
Otolith Labs
Washington D.C., District of Columbia, United States, 20009