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Efficacy of a Non-invasive Vestibular System Masking for Improving Outcomes Following Acute Unilateral Vestibulopathy

NCT04226976 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-22

No results posted yet for this study

Summary

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. Acute unilateral vestibulopathy (AUV) is easy to diagnose and is commonly treated with physical therapy exercises called vestibular rehabilitation. But due to the discomfort experienced during AUV, patients can't usually comply with the treatment plan prescribed by their healthcare provider.

In this study, the investigators propose the use of an adjuvant device, the OtoBand, to improve balance, gait, reduce vertigo, and nausea in participants with AUV. Participants enrolled will undergo three vestibular tests batteries: one baseline, one with the OtoBand set at an effective power, and one with the placebo device set at low power. Neither participants nor investigator will know which device is effective and which is placebo. The OtoBand will be set at two different effective power levels. Which power level the participant will receive is randomized and unknown to the participant or investigator.

Conditions

Interventions

DEVICE

Otoband

Participants with AUV 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.

DEVICE

Placebo Device

Participants with AUV 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.

Sponsors & Collaborators

  • Otolith Labs

    lead INDUSTRY

Principal Investigators

  • Didier Depireux, PhD · Otolith Labs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-05-30
Completion
2024-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT04226976 on ClinicalTrials.gov