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

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



Sponsors


Source

Vanderbilt University Medical Center

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief 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. 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.

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.

Overall Status

Not yet recruiting

Start Date

2017-06-01

Completion Date

2018-06-01

Primary Completion Date

2018-06-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Dix-Hallpike Test
Treatment will take 15 minutes. Patient will be assessed seven days later.
Roll Test
Treatment will take 15 minutes. Patient will be assessed seven days later.

Secondary Outcome

Measure

Time Frame

Dizziness Handicap Inventory
Ten minutes before intervention and seven days after intervention.
Percent Dizziness is Improved
Five minutes before treatment and seven days post-treatment

Enrollment

300

Conditions


Intervention

Intervention Type

Other

Intervention Name


Description

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.

Arm Group Label

Standard Repositioning

Other Name

Epley Maneuver

Semont Liberatory Maneuver

BPPV Treatment Maneuver



Intervention Type

Other

Intervention Name


Description

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.

Arm Group Label

Mechanical Chair Repositioning

Other Name

Epley Maneuver

Semont Liberatory Maneuver

BPPV Treatment Maneuver



Intervention Type

Other

Intervention Name


Description

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

Arm Group Label

Sham Treatment



Eligibility

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- 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.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Contact

Last Name

Richard A Roberts, Ph.D.

Phone

615-322-7384

Email

[email protected]


Verification Date

2017-05-01

Lastchanged Date

2017-05-18

Firstreceived Date

2017-05-15

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Vanderbilt University Medical Center

Investigator Full Name

Richard A. Roberts, Ph.D.

Investigator Title

Assistant Professor


Has Expanded Access

No

Condition Browse


Number Of Arms

3

Arm Group

Arm Group Label

Standard Repositioning

Arm Group Type

Active Comparator

Description

Participants randomly selected for this treatment arm will undergo standard BPPV treatments (canalith repositioning procedure) without the mechanical chair.


Arm Group Label

Mechanical Chair Repositioning

Arm Group Type

Experimental

Description

Participants randomly selected for this treatment arm will undergo standard BPPV treatments (canalith repositioning procedure) with the mechanical chair.


Arm Group Label

Sham Treatment

Arm Group Type

Sham Comparator

Description

Participants 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.



Firstreceived Results Date

N/A

Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

No masking



ClinicalTrials.gov processed this data on May 19, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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