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Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting
N/A
Waitlist Available
Led By Didier Depireux, PhD
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 forms filled out daily over 2 week period by the study participant with the sham in each arm.
Awards & highlights
No Placebo-Only Group
Summary
This study seeks to gather data on the effect of a device, the OtoBand, in participants who have reported symptoms of vertigo, compared to the effect of using one of two sham devices. The study is designed to be conducted remotely using video conferencing between representatives of the manufacturer of the Otoband and participants. In order to comply with requirements for non-essential contact due to the Covid-19 pandemic there will be no person to person contact in the study.
Eligible Conditions
- Vertigo
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ forms filled out daily over four week period by the study participant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~forms filled out daily over four week period by the study participant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in vertigo severity rating while wearing the OtoBand compared to the change in vertigo severity while wearing a sham device.
Secondary study objectives
Average change in vertigo severity rating while wearing the OtoBand compared to average change in vertigo severity while wearing the sham device.
Complaints regarding usage.
Durability of the effect over the observation period.
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Otoband efficacy versus Sham BExperimental Treatment2 Interventions
Participants in Arm 2 will receive, in random order, a OtoBand or Sham Device B. Sham Device B is an OtoBand that operates at settings found to be non-therapeutic in motion sickness studies. There will be a two-day washout period between the devices. For the second two weeks, the participants will receive the alternate device (i.e., sham, or effective).
Group II: Otoband efficacy versus Sham AExperimental Treatment2 Interventions
Participants in Arm 1 will receive, in random order, an OtoBand or Sham Device A to use for two weeks each. Sham Device A is an OtoBand in which the transducer is modified so that the vibrations do not target the vestibular system. There will be a two-day washout period between the devices. For the second two weeks, the participants will receive the alternate device (i.e., sham or effective).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Otoband
2021
N/A
~30
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Who is running the clinical trial?
Otolith LabsLead Sponsor
10 Previous Clinical Trials
540 Total Patients Enrolled
6 Trials studying Vertigo
418 Patients Enrolled for Vertigo
Didier Depireux, PhD5.01 ReviewsPrincipal Investigator - OtolithLabs
Otolith Labs
6 Previous Clinical Trials
432 Total Patients Enrolled
3 Trials studying Vertigo
310 Patients Enrolled for Vertigo
5Patient Review
This fantastic physician was both nice and expedient. I hardly waited. Their nursing team was also very nice to me. Would happily return to have stitches removed again.