Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting

NCT04869020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

  • Vertigo

Interventions

DEVICE

Otoband

Participants with vertigo will wear the Otoband set at their chosen power level when experiencing symptoms.

DEVICE

Sham A

Sham Device A is an OtoBand in which the transducer is modified so that the vibrations are not targeted at the vestibular system.

DEVICE

Sham B

Sham Device B is an OtoBand that operates at power settings found to be nontherapeutic against vertigo associated with virtual reality.

Sponsors & Collaborators

  • Otolith Labs

    lead INDUSTRY

Principal Investigators

  • Didier Depireux, PhD · OtolithLabs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2021-12-27
Completion
2022-11-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04869020 on ClinicalTrials.gov