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BPPV Treatment in Biaxial Rotational Chair

Primary Purpose

Benign Paroxysmal Positional Vertigo

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Biaxial rotational chair
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring Vertigo and dizziness., semicircular canals

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Barbecue treatment without acceleration

Barbecue treatment with acceleartion

Placebo treatment

Arm Description

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

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.

Positional examination 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 a rotation towards the other side.

Outcomes

Primary Outcome Measures

Effect of change in velocity in treatment of lateral canal BPPV
Two week cure rate

Secondary Outcome Measures

Effect of change in velocity in treatment of lateral canal BPPV
Difference in dynamic barbecue and stepwise barbecue three months after treatment (Cure rate and DHI)

Full Information

First Posted
July 15, 2013
Last Updated
November 12, 2018
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01905800
Brief Title
BPPV Treatment in Biaxial Rotational Chair
Official Title
Randomized Multicenter Study of Benign Paroxysmal Positional Vertigo Treatment in Biaxial Rotational Chair
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo
Keywords
Vertigo and dizziness., semicircular canals

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Barbecue treatment without acceleration
Arm Type
Active Comparator
Arm Description
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
Arm Title
Barbecue treatment with acceleartion
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo treatment
Arm Type
Placebo Comparator
Arm Description
Positional examination 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 a rotation towards the other side.
Intervention Type
Device
Intervention Name(s)
Biaxial rotational chair
Other Intervention Name(s)
TRV chair
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of change in velocity in treatment of lateral canal BPPV
Description
Two week cure rate
Time Frame
Four years
Secondary Outcome Measure Information:
Title
Effect of change in velocity in treatment of lateral canal BPPV
Description
Difference in dynamic barbecue and stepwise barbecue three months after treatment (Cure rate and DHI)
Time Frame
Four years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camilla Martens, MD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stein Helge Nordahl Glad
Organizational Affiliation
Haukeland University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to make individual participant data (IPD) available
Citations:
PubMed Identifier
32864448
Citation
Martens C, Goplen FK, Aasen T, Gjestad R, Nordfalk KF, Nordahl SHG. Treatment of horizontal canal BPPV-a randomized sham-controlled trial comparing two therapeutic maneuvers of different speeds. Laryngoscope Investig Otolaryngol. 2020 Jun 29;5(4):750-757. doi: 10.1002/lio2.420. eCollection 2020 Aug.
Results Reference
derived

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BPPV Treatment in Biaxial Rotational Chair

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