Efficacy of a Mechanical Chair for Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
NCT03161470 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2020-10-08
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.
Conditions
- Vertigo
- Benign Paroxysmal Positional Vertigo
Interventions
- 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
-
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
-
Sham Treatment
Participants will be placed into the mechanical chair and moved into various positions that do not treat BPPV.
Sponsors & Collaborators
-
Vanderbilt University Medical Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-08
- Primary Completion
- 2020-09-05
- Completion
- 2020-09-05
Countries
- United States
Study Locations
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