An interventional study of Otoband and Placebo Device in Dizziness, Vertigo and Vestibular Migraine, sponsored by Otolith Labs. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by Otolith Labs · Not applicable, Interventional, and Treatment
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.
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. At the current time, the mainstay of therapy for many vestibular disorders is a physical therapy called vestibular rehabilitation. While usually highly effective, this therapy is time consuming and not universally effective, in part because of inconsistent subject compliance. The use of adjuvant devices to speed recovery has been studied but very few devices have proved beneficial; the few that have shown benefit only work in special populations and are large units that cost several million dollars.
In this study, the investigators will assay the efficacy of the OtoBand in participants with vertigo and dizziness. The OtoBand will be given to participants with vertigo and dizziness in patients with vestibular dysfunction. Participants will be recruited from patients who present at the Dizziness and Vertigo Institute of Los Angeles and for whom the Principal Investigators recommend a course of vestibular rehabilitation therapy. The OtoBand will be set at either a normal power (effective) or low power (lower than the power level thought to be effective, placebo device). Participants will not know if they are receiving receiving bone conducted stimulation 1) at a therapeutic level or 2) at a non therapeutic level.
This study seeks to determine if, in patients going to the Dizzy and Vertigo Institute of Los Angeles for vestibular rehabilitation therapy, objective measures of dizziness and vertigo are significantly changed by wearing the OtoBand.
Potential changes will be measured in the following tests:
In this current protocol, three conditions (sham, therapeutic and no device) will be tested within an hour in a randomized sequence, with the OtoBand remaining in place throughout (turned off in the "no device" condition).
The primary endpoint of the study is to determine the change(s) induced by the OtoBand in objective measures of vestibular symptoms.
The secondary endpoints of the study include:
226 studies on the registry are indexed under Dizziness; 56 are open to participants now.
This study's enrollment of 28 is below the median of 43 across 170 interventional studies indexed under Dizziness.
Browse Dizziness studies →Otolith Labs is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Classified as having vertigo from one of the following vestibulogenic vertigo conditions:
Exclusion Criteria:
Prior documented neurodegenerative disorders of hearing and balance including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Otoband
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.
Device: Placebo Device
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.
Participants with Dizziness and Vertigo will wear the Otoband set at normal power (effective) during vestibular test battery and outcome measurements will be recorded by the investigator during site visit.
Participants with Dizziness and Vertigo will wear the placebo device set at low power during vestibular test battery and outcome measurements will be recorded by the investigator during site visit.
Determine change in objective measures of vestibular symptoms, namely change in VOR Gain induced by the OtoBand.
We measure the Gain of the Vestibular Ocular Reflex (VOR) associated with sinusoidal harmonic accelerations (SHAs) at multiple frequencies of rotation. The mean Gain across all frequencies will be computed for each three experimental conditions (OtoBand/sham/no device). The quantifiable outcome will be the deviation from nominal values of the Gain as a function of experimental condition.
Time frame: Within 60 minute trial period.
Determine change in objective measures of vestibular symptoms, namely change in VOR Phase induced by the OtoBand.
We measure the Phase of the Vestibular Ocular Reflex (VOR) associated with sinusoidal harmonic accelerations (SHAs) at multiple frequencies of rotation. The mean phase lag across all frequencies will be computed for each three experimental conditions (OtoBand/sham/no device). The quantifiable outcome will be the deviation from nominal values of the phase lag as a function of experimental condition.
Time frame: Within 60 minute trial period.
Participant's questionnaire as to which power level they believe were sham setting vs therapeutic setting
Compare participants' estimation of which device provided the most benefits, to the improvement in VOR gain measured during sinusoidal harmonic accelerations (SHAs).
Time frame: Within 60 minute trial period.
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)
Measure statistically significant changes in VOR gain as measured from Sinusoidal Harmonic Accelerations (SHAs) and spontaneous nystagmus, as a function of the OtoBand's power level and as a function of the participant's condition (vestibular migraine vs vestibulopathy)
Time frame: Within 60 minute trial period.
Determine change in objective measures of vestibular symptoms, namely change in residual nystagmus following SHAs, as a function of experimental condition.
Following sinusoidal harmonic accelerations (SHAs) in the rotary chair, we measure residual eye movements (nystagmus) for one minute at rest. The amplitude and frequency of these eye movements will be computed for each three experimental conditions (OtoBand/sham/no device). The quantifiable outcome will be the deviation from nominal values of the nystagmus as a function of experimental condition.
Time frame: Within 60 minute trial period.
Plan to share: No
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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