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

NCT04226976 | Suspended DMC FDA Device

• 1 other identifier: OLith10501
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dizziness; Nausea

Outcome Measures

Primary Outcomes (3)

• Change in vestibular function as measured by Functional Gait Assessment

  Measure statistically significant change in postural stability in acute vestibular patients, by obtaining the participants' scores on the Functional Gait Assessment (FGA). An ANOVA will be performed on the FGA scores - without a device, - with an Otoband set at a subtherapeutic power level and - with an Otoband set at a therapeutic power level.

  Three tests over 30 minutes - During 1-day visit at the University of Miami Health System.

• Change in vestibular function as measured by Dizziness Handicap Inventory

  Measure statistically significant change in perception of dizziness by administering the Dizziness Handicap Inventory (DHI) immediately following the gait tasks of the Functional Gait Assessment. An ANOVA comparison will be performed between the set of DHI scores - without a device, - with an Otoband set at a subtherapeutic power level and - with an Otoband set at a therapeutic power level.

  Three times immediately following FGA testing - During 1-day visit at the University of Miami Health System.

• Change in vestibular function as measured by I-PAS testing

  Measure statistically significant change in vestibular function and reduction in vestibular symptoms, as measured from the participant's score on the I-PAS test battery. The I-PAS consists in "video Head Impulse Testing" (vHIT) and the "Oculomotor, Vestibular, and Reaction Time" testing (OVRT). An ANOVA comparison will be performed between the set of scoresI-PAS scores - without a device, - with an Otoband set at a subtherapeutic power level and - with an Otoband set at a therapeutic power level.

  Three tests over one hour - During the 1-day visit at the University of Miami Health System.

Secondary Outcomes (1)

• Differential effect of bone conduction level on vestibular improvements

  Summary data at end of study (1 year)

Study Arms (2)

Otoband efficacy on AUV

EXPERIMENTAL

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.

Device: Otoband

Placebo device efficacy on AUV

PLACEBO COMPARATOR

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.

Device: Placebo Device

Interventions

Otoband 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.

Otoband efficacy on AUV

Placebo Device 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.

Placebo device efficacy on AUV

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Resolved vestibular hypofunction by the time of visit to clinic
• History of head injury within the last six months or currently suffering the effects of a head injury
• Presence of severe aphasia
• History of diagnosed, untreated neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
• Documented neurodegenerative disorders
• Prior disorders of hearing and balance including:
• Ménière's disease
• Multiple sclerosis
• Vestibular neuritis (prior resolved episode)
• Vestibular schwannoma
• Sudden sensorineural hearing loss
• History of Cerebrovascular disorders
• History of ear operation other than myringotomy (tube placement) in the past
• Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis
• Individuals who cannot provide informed consent

Sponsors & Collaborators

• Otolith Labs: lead

Study Sites (1)

University of Miami Health System

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Dizziness; Nausea

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Didier Depireux, PhD

  Otolith Labs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The sponsor will be randomly assigning the Otoband or placebo device to participants. The investigator will not know which device is assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants with Acute Unilateral Vestibulopathy (AUV) will be asked to participate in the study. Subjects that give consent will be entered into the study and randomized to one of two groups (96dB or 98dB bone conduction level re:1dyne) by the study coordinator. Neither the subject nor the investigators in the study will know to which arm the subject was placed; rather the study coordinator will be given two sets of two OtoBands. When turned on, both the effective devices and placebo will be felt to vibrate, making it difficult for the typical subject or investigator to guess which device is effective and which is the placebo. After randomization, all subjects will undergo the vestibular battery. The subjects will complete a Participant Questionnaire following the testing.

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: January 13, 2020
• Study Start: June 1, 2022
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)