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NCT Number: NCT01905800

BPPV Treatment in Biaxial Rotational Chair

Benign paroxysmal positional vertigo (BPPV) represents the most common cause of labyrinthine vertigo with a lifetime prevalence of 2.4 percent. Onset is most common between the fifth and seventh decades of life. The disease can be a major handicap for the affected patient, and causes a great expense for society. The traditional manual treatment with repositioning maneuvers has greatly improved the possibilities for treatment of BPPV the last decade. However some patients are still difficult to diagnose and treat, and there are some who for health reasons cannot undergo traditional manual treatment. In this perspective there is a demand for a reliable, effective and precise method to treat all semicircular canals for the differentiated patient groups, and the techniques are under continuous development.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

About this study

There has been extended research to improve the techniques and develop better and more reliable methods for diagnosing and treating BPPV efficiently. An important part in this technique evolution is the development of biaxial rotational chairs that can treat the patients regardless of other health problems.

Mechanical assistance chairs have been designed to diagnose, differentiate and treat more precisely all forms of positional vertigo. The patient is strapped to a chair and fitted with infrared video goggles which identify and quantify the nystagmus in different positions. Dr. John M. Epley developed the Epley Omniax System, an automated, power driven, multi axial patient positioning device that can move the patient into any position to treat the affected canal. This chair is electronically managed. Another mechanical assistance chair, the TRV chair, developed by Thomas Richard-Vitton in Marseille France, became commercially available in 2005. This chair has a vertical and a horizontal axis of rotation and is lockable in preset positions. It is manually handled and can swivel between two axes in all planes of the semicircular canals for up to 360 degrees or more. Velocity of rotation can be regulated freely.

The TRV chair is used by 34 centers worldwide today. Bergen (Norway) was the first place in North-Europe to acquire this chair, and have used it since December 2009. In 2013 Rigshospitalet Denmark started using the TRV chair as well and Oslo University Hospital Rikshospitalet, will have their chair in 2013. The TRV chair opens for treatment that previously was not possible.

The aim of this study is to:

  • Evaluate the presence of positional nystagmus in the normal population
  • Evaluate the efficacy of D-BBC treatment compared to S-BBC for treatment of lateral canal BPPV in TRV chair
  • Examine the serum level of vitamin D in BPPV patients
  • Give a detailed description of the method.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subjects over 18 years with benign paroxysmal positional vertigo(BPPV)

Exclusion criteria

  • BPPV previously treated with reposition maneuvers within the last 12 months.
  • Cochlear Implant (CI).
  • Asymmetrical hearing loss.
  • Unusual headache.
  • Neurological disease.
  • Inner ear disease other than BPPV.
  • Semicircular canal paresis.
  • Drug that causes dizziness/nystagmus.
  • Chemotherapy.
  • Hospital admission due to head trauma within the last 12 months.
  • Closeness to study group.
  • Downbeating nystagmus or upbeating nystagmus without torsional component.
  • Extensive spontaneous nystagmus that complicates gait interpretation.
  • Cannot tolerate both treatments.
  • Pregnancy.
  • Bilateral affection of the semicircular canals.
  • More than two semicircular canals affected on one side.

Treatment and study plan

Biaxial rotational chair

Device

This chair has a vertical and a horizontal axis of rotation and is lockable in preset positions. It is manually handled and can swivel between two axes in all planes of the semicircular canals for up to 360 degrees or more. Velocity of rotation can be regulated freely.

Other names: TRV chair

Primary outcomes

  1. Effect of change in velocity in treatment of lateral canal BPPV

    Time frame: Four years

    Two week cure rate

Secondary outcomes

  1. Effect of change in velocity in treatment of lateral canal BPPV

    Time frame: Four years

    Difference in dynamic barbecue and stepwise barbecue three months after treatment (Cure rate and DHI)

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

Randomized Multicenter Study of Benign Paroxysmal Positional Vertigo Treatment in Biaxial Rotational Chair

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 23, 2013
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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