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VertigoNCT03161470

Efficacy of a Mechanical Chair for Treatment of Benign Paroxysmal Positional Vertigo (BPPV)

A study testing Standard Repositioning and Mechanical Chair Repositioning in people with Vertigo and Benign Paroxysmal Positional Vertigo, run by Vanderbilt University Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Benign paroxysmal positional vertigo (BPPV) is the most common inner ear cause of dizziness. It has been reported that up to 900 of every 10,000 people in the United States experience this problem with an estimated annual healthcare cost approaching $2 Billion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vertigo, Benign Paroxysmal Positional Vertigo
What is being tested?
Standard Repositioning and Mechanical Chair Repositioning
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13 participants
Where
1 siteUnited States
Study dates
8 Jun 2017to 5 Sep 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All adult patients identified with BPPV through the Vanderbilt Balance Disorders Clinic or diagnosed with BPPV by Vanderbilt Otolaryngology will be eligible for inclusion.

Who cannot join

  • Patients without BPPV. Also, the mechanical chair is contraindicated for for patients weighing over 330 lbs, patients presenting with unusual headache symptoms, uncontrolled high blood pressure or some associated neurological symptoms or any other atypical findings. It must not be used if the patient has undergone neurosurgery or cardiac surgery within the past month.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Benign paroxysmal positional vertigo (BPPV) is the most common inner ear cause of dizziness. It has been reported that up to 900 of every 10,000 people in the United States experience this problem with an estimated annual healthcare cost approaching $2 Billion. This problem occurs when calcium carbonate "crystals" which are present and needed in one part of the balance area of the inner ear become displaced to a different part of the balance area. This is very disruptive to the function of the inner ear and results primarily in intense vertigo. Nausea,imbalance, and falls can also occur. The accepted course of management for BPPV is the use of "repositioning maneuvers" which are completed by moving patients through specific head/body positions that literally reposition the displaced crystals out of the wrong area. These treatment methods are reported to be effective for about 80% of patients after one-to-three treatments. For the remaining 20% of patients, more treatments may be necessary and for a small percentage of patients surgical options may be the only cure. Additionally, some patients with BPPV are not able to physically move into the needed positions because of hip and neck problems, spinal problems, obesity, other mobility limitations, etc. Within the past decade, a motorized chair was developed to help reposition any patient with BPPV. There have been no reported adverse incidents with the motorized chair but the device was quite expensive so it was only available at a handful of clinical sites. At this time the motorized chair is no longer being manufactured. More recently, a mechanical chair was developed and has been in use in Europe and China. The mechanical chair has all the advantages of the motorized chair but with a lesser cost. The inventor of the mechanical chair has also developed some slight variations on treatment technique that may have the potential to improve treatment efficacy. We are privileged to have the only mechanical chair of this type in the United States. The primary purpose of the current project is to systematically investigate the treatment efficacy of this mechanical chair for patients with BPPV. We will compare treatment outcomes for patients diagnosed with BPPV using standard methods, the mechanical chair, and a sham condition also using the mechanical chair. A secondary purpose is to determine treatment efficacy for patients with covert BPPV. We will simply measure if treatment with the mechanical chair has any effect on patient symptoms. If we determine treatment is improved with the mechanical chair then it may be possible to help a greater number of patients with BPPV with fewer treatments.

Read the detailed description

Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo (Bhattacharyya et al., 2017). BPPV is estimated to affect 900 out of 10,000 people annually (Kerrigan et al., 2013) with healthcare costs approaching $2 Billion (Bhattacharyya et al., 2017). We have shown that patients with BPPV rate the impact on their quality of life similar to patients with macular degeneration, hepatitis B, and HIV/AIDS (Roberts et al., 2009). BPPV occurs when calcium carbonate crystals from one part of the inner ear balance system (utricle) become displaced into other parts of the inner ear balance system (semicircular canal). Normal head and body movements cause movement of the crystal debris within the semicircular canals. This movement causes changes in stimulation of the sensory structures of the semicircular canals that result in vertigo, nausea, imbalance, and even falls. It is well established that BPPV affects the posterior semicircular canal 80% of the time, the horizontal canal 15% of the time and the anterior canal 5% of the time.

There are established methods that have been proven to be effective in treatment of BPPV with randomized controlled trials (Hilton \& Pinder, 2014). Each of these methods involves moving a patient's head and body through specific positions to remove the debris from the involved canal. However, many of these patients require multiple treatments and there is a group of patients with BPPV that do not respond to these treatments and for whom surgical options are ultimately considered. Further, patients with hip or neck problems, spinal issues, and even obesity are often unable to be placed in or move through the required positions.

A motorized chair was developed to improve treatment consistency and efficacy and broaden the group of patients who could receive appropriate treatment (Nakayama \& Epley, 2005). Although the motorized chair was effective and there are no known reports of adverse events, it was also very expensive. Few facilities were able to purchase the motorized chair so the anticipated impact on helping patients with BPPV was never realized. The motorized chair is no longer being manufactured. A mechanical chair for assessment and treatment of BPPV was also described around the same time as the motorized chair (Richard-Vitton et al., 2005). This is referred to as the TRV chair which are the initials of the inventor.

This mechanical chair has been used in several countries including across Europe and in China. Wang et al. (2014) reported they were able to clear various types of BPPV in 202 of 208 (97.1%) cases. The remaining six cases reported significant improvement. There was no control group in this study and the inventor is listed as an author. No adverse events were reported. West et al. (2016) completed a retrospective chart review of patients treated for BPPV in their clinic.Interestingly, they had both the TRV chair and the motorized chair. Some of their patients also underwent treatment with traditional methods which do not incorporate a specialized chair to help position patients. The authors concluded that specialized chairs (motorized or mechanical) are useful for treatment of BPPV, especially for more difficult cases. There are also some limitations with this report in that no control group was used and participants were not randomly assigned to a treatment type. Patients with a typical history of BPPV, and identified with the most common type affecting the posterior canal, were treated with the traditional methods first and then perhaps with a specialized chair. Other patients were treated with both types of chair. No adverse events were reported.

Specialized chairs do appear to offer some advantages over traditional methods of BPPV treatment. Reports in the literature suggest the specialized chairs are able to treat more difficult cases of BPPV. This should allow improved cure rates for the approximately 20% of patients that require multiple treatments using the traditional methods. Use of specialized chairs would also increase the number of patients who can be treated because there are no contraindications related to hip, spine, and mobility issues as there are for traditional methods of BPPV treatment. The mechanical chair (TRV chair) appears to offer all of the advantages of the motorized chair but at a lessor cost anticipated to be $65,000 compared to $100,000 for the motorized chair. One may speculate there is less maintenance required for a mechanical versus a motorized system and there is the fact that the currently described motorized version is no longer available for purchase.

The primary purpose of this project is to determine treatment efficacy of the motorized TRV chair for patients with BPPV. This information has not been published using a randomized controlled design. A secondary purpose of the project is to determine if the TRV chair is helpful in patients experiencing chronic symptoms of dizziness and unsteadiness who may have complaints suggesting positional vertigo but who fail to generate nystagmus (i.e. covert BPPV). If the TRV chair is more efficacious than traditional methods, our hope is that nearly all patients with BPPV will be able to be managed in a more efficient manner. This will decrease the impact of BPPV on health-related quality of life, could decrease falls related to BPPV, and should also decrease the burden of healthcare costs.

Being tested
Standard Repositioning, Mechanical Chair Repositioning, Sham Treatment
Medical subject headings
Vertigo, Benign Paroxysmal Positional Vertigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard RepositioningOther

    Also called Epley Maneuver, Semont Liberatory Maneuver, BPPV Treatment Maneuver

    It is standard clinical practice for patients with BPPV to undergo treatment by moving the patient through specific head/body positions which moves the displaced otoconial debris out of the involved area of the inner ear.

  • Mechanical Chair RepositioningOther

    Also called Epley Maneuver, Semont Liberatory Maneuver, BPPV Treatment Maneuver

    It is standard clinical practice for patients with BPPV to undergo treatment by moving the patient through specific head/body positions which moves the displaced otoconial debris out of the involved area of the inner ear.

  • Sham TreatmentOther

    Participants will be placed into the mechanical chair and moved into various positions that do not treat BPPV.

Study groups in NCT03161470
Study groupRoleWhat they receive
Standard RepositioningActive comparatorParticipants randomly selected for this treatment arm will undergo standard BPPV treatments (canalith repositioning procedure) without the mechanical chair.
Receives: Other: Standard Repositioning
Mechanical Chair RepositioningExperimentalParticipants randomly selected for this treatment arm will undergo standard BPPV treatments (canalith repositioning procedure) with the mechanical chair.
Receives: Other: Mechanical Chair Repositioning
Sham TreatmentSham comparatorParticipants randomly selected for the sham arm will undergo be strapped into the mechanical chair as for the treatment arm but will only undergo the test positions for BPPV-the Dix-Hallpike maneuver. No BPPV repositioning treatment will be completed at the first encounter. At the follow-up visit, standard BPPV treatments (canalith repositioning procedure) will be completed.
Receives: Other: Sham Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dix-Hallpike Test

    This is the test used to determine if a patient is positive or negative for posterior or anterior canal BPPV.

    Measured: Treatment will take 15 minutes. Patient will be assessed seven days later.

  2. Roll Test

    This is the test used to determine if a patient is positive or negative for horizontal canal BPPV.

    Measured: Treatment will take 15 minutes. Patient will be assessed seven days later.

Secondary outcomes (2)
  1. Dizziness Handicap Inventory

    This is a validated subjective measure of impact of dizziness on health-related quality of life.

    Measured: Ten minutes before intervention and seven days after intervention.

  2. Percent Dizziness is Improved

    Patients will rate their dizziness on a zero to 100 point scale. Zero will be no dizziness and 100 will be maximum dizziness.

    Measured: Five minutes before treatment and seven days post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2017
  2. Study start8 Jun 2017
  3. Primary completion5 Sep 2020
  4. Study completion5 Sep 2020

Why it stopped: Physicians/audiologists preferred to manage patients with BPPV immediately rather than enrolling in study except for difficult to treat cases.

Resources

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
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03161470
Sponsor's protocol ID
160176
Status last verified
Oct 2020
First submitted
15 May 2017
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Standard Repositioning and Mechanical Chair Repositioning in people with Vertigo and Benign Paroxysmal Positional Vertigo, run by Vanderbilt University Medical Center 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 8 Oct 2020. 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?

The study was stopped early (reason given: Physicians/audiologists preferred to manage patients with BPPV immediately rather than enrolling in study except for difficult to treat cases.). 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?

Dix-Hallpike Test (time frame: Treatment will take 15 minutes. Patient will be assessed seven days later.). The study lists 2 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 8 Oct 2020.

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