Quantification of the Effect of the OtoBand on Objective Measures of Vertigo and Dizziness (NCT05157399) | Clinical Trial Compass
CompletedNot Applicable
Quantification of the Effect of the OtoBand on Objective Measures of Vertigo and Dizziness
United States28 participantsStarted 2021-11-04
Plain-language summary
Vestibular disorders are among the most common causes of disability in society and affect over 50% of the population over the age of 65 and a significant percentage of the younger population. Vestibular disorders have a dramatic impact on daily life impacting work, relationships, and even activities of daily living.The OtoBand has shown promise and might be beneficial for treating or improving the course of recovery from vestibular disorders.
This study seeks to quantify the effect of the study device, the OtoBand, on objective measures of dizziness and vertigo in patients with vestibular dysfunction.
The study will be conducted at a single-site and will be a blinded, randomized, placebo-controlled design in which participants do not know if they are receiving bone conducted stimulation 1) at a therapeutic level or 2) at a non therapeutic level.
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:
* Vertigo that has been present for at least 90 days, constant or predictable with attacks at least twice a week.
* Classified as having vertigo from one of the following vestibulogenic vertigo conditions:
* Migraine Associated Vertigo, aka Vestibular Migraine
* Chronic Unilateral Vestibulopathy in one of three forms: Persistent Postural-Perceptual Dizziness (aka 3PD), Vestibular Neuritis, Labyrinthitis
* Score \> 35 on Dizziness Handicap Inventory
* Willingness to cease vestibular suppressants for 24h prior to study.
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)
* Resolved vestibular dysfunction by the time of study appointment
* History of head injury within the last 6 months or currently suffering the effects of a head injury
* History of diagnosed untreated neuropsychiatric disorders (hypochondriasis, major depression, schizophrenia)
* Prior documented neurodegenerative disorders of hearing and balance including:
* Multiple sclerosis
* Vestibular schwannoma
* History of Cerebrovascular disorders
* History of ear operation other than myringotomy (tube placement)
* Vitreous detachment of the retina (floaters) in the previous 90 days
* Presence of severe aphasia, and individuals who cannot provide informed consent
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
Determine change in objective measures of vestibular symptoms, namely change in VOR Gain induced by the OtoBand.
Timeframe: Within 60 minute trial period.
2
Determine change in objective measures of vestibular symptoms, namely change in VOR Phase induced by the OtoBand.