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

NCT03161470 | Terminated

• 1 other identifier: 160176
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertigo; Benign Paroxysmal Positional Vertigo

Outcome Measures

Primary Outcomes (2)

• Dix-Hallpike Test

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

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

• Roll Test

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

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

Secondary Outcomes (2)

• 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

Study Arms (3)

Standard Repositioning

ACTIVE COMPARATOR

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

Other: Standard Repositioning

Mechanical Chair Repositioning

EXPERIMENTAL

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

Other: Mechanical Chair Repositioning

Sham Treatment

SHAM COMPARATOR

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

Interventions

Standard Repositioning OTHER

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.

Also known as: Epley Maneuver, Semont Liberatory Maneuver, BPPV Treatment Maneuver

Standard Repositioning

Mechanical Chair Repositioning OTHER

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.

Also known as: Epley Maneuver, Semont Liberatory Maneuver, BPPV Treatment Maneuver

Mechanical Chair Repositioning

Sham Treatment OTHER

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

Sham Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Vertigo; Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 19, 2017
• Study Start: June 8, 2017
• Primary Completion: September 5, 2020
• Study Completion: September 5, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)