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OtoBand Efficacy on Vertigo and Dizziness for Vestibular Migraine

N/A
Waitlist Available
Led By Brooke Pearce, AuD
Research Sponsored by Otolith Labs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 60 minute trial period.
Awards & highlights

Study 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.

Eligible Conditions
  • Vestibular Migraine
  • Labyrinthitis
  • Vestibular Neuritis
  • Dizziness
  • Vertigo

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 60 minute trial period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 60 minute trial period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine change in objective measures of vestibular symptoms, namely change in VOR Gain induced by the OtoBand.
Determine change in objective measures of vestibular symptoms, namely change in VOR Phase induced by the OtoBand.
Secondary outcome measures
Congenital nystagmus
Measure whether Vestibular Migraine and Vestibulopathy patients experience higher benefits from a low vs high bone conduction levels as measured by outcomes of objective tests (SHAs and spontaneous nystagmus)
Participant's questionnaire as to which power level they believe were sham setting vs therapeutic setting

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: OtoBand Efficacy on Vertigo and DizzinessExperimental Treatment1 Intervention
During the single site visit, participants will wear the Otoband, on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. OtoBand will be set to 92dB or 98dB bone conduction level (Re: 1 Dyne). The participants will be fitted with the Otoband and will undergo the vestibular battery test. The investigator will record the outcome measurements.
Group II: No DeviceActive Control1 Intervention
Participants will wear the OtoBand, but turned off, to collect baseline data. This will be randomized. The participants will be fitted with the Otoband and will undergo the vestibular battery test. The investigator will record the outcome measurements.
Group III: Placebo Device Efficacy on Vertigo and DizzinessPlacebo Group1 Intervention
Participants will wear the Otoband, on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. OtoBand set to a bone conduction level 10dB lower than the level used in the experimental condition. Once fitted with the Otoband, participants will undergo the vestibular battery test. The investigator will record the outcome measurements.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Otoband
2021
N/A
~30

Find a Location

Who is running the clinical trial?

Otolith LabsLead Sponsor
9 Previous Clinical Trials
510 Total Patients Enrolled
2 Trials studying Vestibular Migraine
309 Patients Enrolled for Vestibular Migraine
Dizzy and Vertigo Institute of Los AngelesUNKNOWN
Brooke Pearce, AuDPrincipal InvestigatorDizzy and Vertigo Institute of Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Dizzy and Vertigo Institute of Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
California
Recent research and studies
clinicaltrials.govStudy
Quantification of the Effect of the OtoBand on Objective Measures of Vertigo and Dizziness
2021. "Quantification of the Effect of the OtoBand on Objective Measures of Vertigo and Dizziness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05157399.
~8 spots leftby Apr 2025
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