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Otoband efficacy versus Sham A for Vertigo

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

Study Summary

This study is evaluating whether a device may help reduce symptoms of vertigo.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and forms filled out daily over four week period by the study participant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in vertigo severity rating while wearing the OtoBand compared to the change in vertigo severity while wearing a sham device.

Secondary outcome measures

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 more

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

9 Previous Clinical Trials

498 Total Patients Enrolled

6 Trials studying Vertigo

418 Patients Enrolled for Vertigo

Didier Depireux, PhD5.01 ReviewsPrincipal Investigator - OtolithLabs

Otolith Labs

5 Previous Clinical Trials

390 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.