BPPV Treatment in Biaxial Rotational Chair

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Camilla Martens, Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01905800
First received: July 15, 2013
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Benign Paroxysmal Positional Vertigo
Device: Biaxial rotational chair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Multicenter Study of Benign Paroxysmal Positional Vertigo Treatment in Biaxial Rotational Chair

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Treatment of lateral semicircular BPPV, a randomized study comparing dynamic "barbecue" (D-BBC) (rotation about a horizontal axis from head to feet from a supine position) to stepwise barbecue (S-BBC) treatment in a biaxial rotational chair. [ Time Frame: Two years ] [ Designated as safety issue: No ]

    The patients will fill in questionnaires: SF-36, VSS, VAS, Pain chart and DHI before being treated, DHI, VSS and VAS, one week after last treatment, and at the final evaluation three months after last treatment.

    Dynamic/static posturography platform tests will be performed before treatment, one week after last treatment and at end evaluation three months after last treatment.

    Diagnostic and treatment maneuvers will be made with a TRV chair (SYNAPSYS, TRV chair) and positional nystagmus will be analyzed with videonystagmoscopic examination and videonystagmography recording,(SYNAPSYS, model Ulmer VNG) by at least two independent doctors before treatment, one week after last treatment and at end evaluation three months after last treatment.

    Vitamin D status will be checked. Clinical endpoint will be evaluation of treatment efficacy with acceleration and without acceleration in a TRV chair.



Secondary Outcome Measures:
  • Incidence and treatment of BPPV in a biaxial rotational chair (TRV chair). [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Outcome measure will be the same as described in primary outcome measure, but treatment will be for patients with anterior, posterior and horizontal BPPV.


Other Outcome Measures:
  • Incidence of positional nystagmus in a normal population. [ Time Frame: Two years ] [ Designated as safety issue: No ]

    We will record and analyze the positioning nystagmic features in a normal population.

    Dynamic/static posturography platform tests will be performed Diagnostic maneuvers will be made with a mechanical assistance TRV chair (SYNAPSYS, TRV chair) and positional nystagmus will be analyzed with videonystagmoscopic examination and videonystagmography recording,(SYNAPSYS, model Ulmer VNG) by at least two independent doctors.

    Vitamin D status will be checked.



Estimated Enrollment: 350
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nystagmus in normal population
Investigate positional nystagmus in normal population using a biaxial rotational chair.
Device: Biaxial rotational chair
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 Name: TRV chair
Experimental: BPPV treatment in TRV chair
BPPV treatment in Biaxial rotational chair, description and measuring efficacy of treatment.
Device: Biaxial rotational chair
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 Name: TRV chair
Active Comparator: Barbecue treatment without acceleration
Treatment of horizontal BPPV with adapted maneuvers using a biaxial rotational chair and infrared videoscopy goggle. The patient is positioned in supine position and rotated 30 degrees stepwise towards the unaffected ear, thus applying an overall 360 degrees rotation. The patient remains in each position for 30 seconds
Device: Biaxial rotational chair
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 Name: TRV chair
Experimental: Barbecue treatment with acceleartion
Treatment of horizontal BPPV with adapted maneuvers using a biaxial rotational chair and infrared videoscopy goggle. The patient starts in supine position and will be rotated about a horizontal axis from head to feet. The patient will be rotated 360 degrees with a succession of eight fast rounds in the axial plane towards the unaffected side.
Device: Biaxial rotational chair
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 Name: TRV chair

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01905800

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Camilla Martens, Cand.med    +47 55973220    camilla.martens@helse-bergen.no   
Contact: Stein Helge Glad Nordahl, MD. Phd    +47 55972666    stein.nordahl@helse-bergen.no   
Principal Investigator: Camilla Martens, Cand.med         
Sponsors and Collaborators
Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Camilla Martens, Cand.med, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01905800     History of Changes
Other Study ID Numbers: 2013/980
Study First Received: July 15, 2013
Last Updated: September 13, 2013
Health Authority: Norway: Ethics Committee

Keywords provided by Haukeland University Hospital:
Vertigo and dizziness.
semicircular canals

Additional relevant MeSH terms:
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders

ClinicalTrials.gov processed this record on July 20, 2014