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

NCT ID: NCT04226976

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Otoband efficacy on AUV

Participants will wear the Otoband during the single site visit against the skin, on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. Half the participants will be given the Otoband at power level 96db and half will be given the Otoband at power level 98db (all bone conduction levels re:1dyne). This will be randomized and neither the participant nor the investigator will know what power level the Otoband is set at. The participants will be fitted with the Otoband and will undergo the vestibular battery test. The investigator will record the outcome measurements.

Group Type: EXPERIMENTAL

Otoband

Intervention Type: DEVICE

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.

Placebo device efficacy on AUV

Participants will wear the placebo device during the single site visit against the skin, on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. The placebo device will be set at a power level of 90db (bone conduction level re:1dyne). Neither the participant nor the investigator will know that this device is the placebo device. The participants will be fitted with the placebo device and will undergo the vestibular battery test. The investigator will record the outcome measurements.

Group Type: PLACEBO_COMPARATOR

Placebo Device

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Subject between the ages of 18-70 with an acute unilateral vestibulopathy as characterized by the following

• Acute onset vertigo that lasts at least 6 hours within the previous 2 weeks.
• A feeling of unsteadiness or feeling off balance for at least 48 hours after conclusion of vertigo
• Confirmed unilateral vestibulopathy on head rotation test or caloric test

Exclusion Criteria

1. Resolved vestibular hypofunction by the time of visit to clinic

2. History of head injury within the last six months or currently suffering the effects of a head injury

3. Presence of severe aphasia

4. History of diagnosed, untreated neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)

5. Documented neurodegenerative disorders

6. Prior disorders of hearing and balance including:

1. Ménière's disease

2. Multiple sclerosis

3. Vestibular neuritis (prior resolved episode)

4. Vestibular schwannoma

5. Sudden sensorineural hearing loss

7. History of Cerebrovascular disorders

8. History of ear operation other than myringotomy (tube placement) in the past

9. Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis

10. Individuals who cannot provide informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otolith Labs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Didier Depireux, PhD

Role: STUDY_DIRECTOR

Otolith Labs

Locations

University of Miami Health System

Miami, Florida, United States

Countries

United States

Other Identifiers

OLith10501

Identifier Type: -

Identifier Source: org_study_id