Quantification of the Effect of the OtoBand on Objective Measures of Vertigo and Dizziness
Completed · Not applicable · Has a placebo group
Conditions studied: Dizziness, Vertigo, Vestibular Migraine, Vestibular Neuritis, Labyrinthitis
In brief
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.
Key facts
- Study ID
- NCT05157399
- Run by
- Otolith Labs
- People needed
- 28
- Starts
- 2021-11-04
- Expected to finish
- 2022-09-01
- Last updated by the study team
- 2022-11-15
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Dizzy and Vertigo Institute of Los Angeles — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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