DizzinessNCT04226976
Efficacy of a Non-invasive Vestibular System Masking for Improving Outcomes Following Acute Unilateral Vestibulopathy
A study testing Otoband in people with Dizziness and Nausea, run by Otolith Labs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Otoband
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Health System
Miami, Florida, 33136
About this study
Official title: Efficacy of a Non-invasive Vestibular System Masking for the Abortive Treatment of Vertigo for Patients With Acute Unilateral Vestibulopathy (AUV)
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.
Read the 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:
- Determine if participants treated with OtoBand achieve instantaneous effectiveness in reducing vestibular symptoms.
- Determine if participants treated with the OtoBand at higher power levels experience higher benefits.
- Being tested
- Otoband, Placebo Device
- Medical subject headings
- Dizziness, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtobandDevice
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 DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
The trial has two groups of participants: half of the participants are tested with the OtoBand set at a bone conduction level found to be optimally effective in healthy subjects, and half of the participants are tested with the OtoBand set at a higher bone conduction level. A statistical test will be used to determine whether acute unilateral vestibulopathy participants, as a group, experience higher or lower benefits from the higher bone conduction power level, using the measures of the three primary outcomes (FGA, DHI, I-PAS).
Measured: Summary data at end of study (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jun 2022 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Why it stopped: COVID-19 general concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otolith Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Didier Depireux, PhD, Study director, Otolith Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226976
- Sponsor's protocol ID
- OLith10501
- Status last verified
- Mar 2022
- First submitted
- 18 Dec 2019
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Non-invasive Vestibular System Masking for the Abortive Treatment of Vertigo for Patients With Acute Unilateral Vestibulopathy (AUV)
- ClinicalTrials.gov ID
- NCT04226976
- Acronym / sponsor ID
- OLith10501
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19 general concerns
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Otolith LabsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine if participants treated with OtoBand achieve instantaneous effectiveness in reducing vestibular symptoms.
- Determine if participants treated with the OtoBand at higher power levels experience higher benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Otoband efficacy on AUV | Experimental | Device: OtobandParticipants 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. |
| Placebo device efficacy on AUV | Placebo comparator | Device: Placebo DeviceParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtobandParticipants 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 | Otoband efficacy on AUV |
| Placebo DeviceParticipants 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. | Device | Placebo device efficacy on AUV |
Primary outcome
Change in vestibular function as measured by Functional Gait Assessment
Time frame: Three tests over 30 minutes - During 1-day visit at the University of Miami Health System.
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.
Change in vestibular function as measured by Dizziness Handicap Inventory
Time frame: Three times immediately following FGA testing - During 1-day visit at the University of Miami Health System.
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.
Change in vestibular function as measured by I-PAS testing
Time frame: Three tests over one hour - During the 1-day visit at the University of Miami Health System.
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.
1 secondary outcome
Differential effect of bone conduction level on vestibular improvements
Time frame: Summary data at end of study (1 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Depireux, PhD study director
Otolith Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otoband in people with Dizziness and Nausea, run by Otolith Labs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vestibular function as measured by Functional Gait Assessment (time frame: Three tests over 30 minutes - During 1-day visit at the University of Miami Health System.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.