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


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Verified May 2017 by Vanderbilt University Medical Center

Sponsor:

Information provided by (Responsible Party):

Richard A. Roberts, Ph.D., Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT03161470

First received: May 15, 2017

Last updated: May 18, 2017

Last verified: May 2017

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.

Vertigo
Benign Paroxysmal Positional Vertigo
Other: Standard Repositioning
Other: Mechanical Chair Repositioning
Other: Sham Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Efficacy of a Mechanical Chair for Treatment of Benign Paroxysmal Positional Vertigo (BPPV)

Primary Outcome Measures:

  • Dix-Hallpike Test [ Time Frame: Treatment will take 15 minutes. Patient will be assessed seven days later. ]

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

  • Roll Test [ Time Frame: Treatment will take 15 minutes. Patient will be assessed seven days later. ]

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

Secondary Outcome Measures:

  • Dizziness Handicap Inventory [ Time Frame: Ten minutes before intervention and seven days after intervention. ]

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

  • Percent Dizziness is Improved [ Time Frame: Five minutes before treatment and seven days post-treatment ]

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

Estimated Enrollment: 300
Anticipated Study Start Date: June 1, 2017
Estimated Study Completion Date: June 1, 2018
Estimated Primary Completion Date: June 1, 2018 (Final data collection date for primary outcome measure)
Active Comparator: Standard Repositioning

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

Other: Standard Repositioning

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.

Other Names:

  • Epley Maneuver
  • Semont Liberatory Maneuver
  • BPPV Treatment Maneuver
Experimental: Mechanical Chair Repositioning

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

Other: Mechanical Chair Repositioning

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.

Other Names:

  • Epley Maneuver
  • Semont Liberatory Maneuver
  • BPPV Treatment Maneuver
Sham Comparator: Sham Treatment

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.

Other: Sham Treatment

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT03161470

Vanderbilt University Medical Center

Responsible Party: Richard A. Roberts, Ph.D., Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03161470     History of Changes
Other Study ID Numbers: 160176
Study First Received: May 15, 2017
Last Updated: May 18, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Vertigo
Dizziness
Benign Paroxysmal Positional Vertigo
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders

ClinicalTrials.gov processed this record on May 19, 2017