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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 mechan

Detailed Summary:

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 (Naka
Sponsor: Vanderbilt University Medical Center

Current Primary Outcome:

• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.

Original Secondary Outcome: Same as current

Information By: Vanderbilt University Medical Center

Dates:
Date Received: May 15, 2017
Date Started: June 1, 2017
Date Completion: June 1, 2018
Last Updated: May 18, 2017
Last Verified: May 2017