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Quantification of the Effect of the OtoBand on Objective Measures of Vertigo and Dizziness
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.
Summary
This trial tests the OtoBand, a device that sends gentle vibrations through the head, on patients with dizziness and balance issues. It aims to see if these vibrations can help improve their symptoms.
Eligible Conditions
- Vertigo
- Labyrinthitis
- Migraine
- Dizziness
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 60 minute trial period.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 60 minute trial period.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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
10 Previous Clinical Trials
552 Total Patients Enrolled
6 Trials studying Vertigo
430 Patients Enrolled for Vertigo
Dizzy and Vertigo Institute of Los AngelesUNKNOWN
1 Previous Clinical Trials
42 Total Patients Enrolled
Brooke Pearce, AuDPrincipal InvestigatorDizzy and Vertigo Institute of Los Angeles