NCT04226976

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

Efficacy of a Non-invasive Vestibular System Masking for the Abortive Treatment of Vertigo for Patients With Acute Unilateral Vestibulopathy (AUV)

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Otolith Labs · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The OtoBand has shown promise and might be beneficial for treating or improving the course of recovery from vestibular disorders. To date, the device has only been systematically tested on healthy volunteers and has been shown to improve vertigo associated to motion sickness and virtual reality device use. In this study, the investigators will assay the efficacy of the OtoBand on participants with acute unilateral vestibulopathy (AUV). The OtoBand will be given to participants with AUV for use during vestibular test batteries. The OtoBand will be set at either a normal power (effective) or low power (6 decibels lower than normal power, placebo device). There are two effective power levels, which will be randomly assigned to each of the participants. Outcomes will be assessed by the investigator by a set of vestibular tests while the participant uses the OtoBand or placebo device. Participants vestibular disorder outcomes will be compared between OtoBand and placebo device to: 1. Determine if participants treated with OtoBand achieve instantaneous effectiveness in reducing vestibular symptoms. 2. Determine if participants treated with the OtoBand at higher power levels experience higher benefits.

Conditions

• Dizziness
• Nausea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-05-30
• Completion: 2024-06-30
• First posted: 2020-01-13
• Last updated: 2022-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study