BPPV Treatment in Biaxial Rotational Chair

NCT01905800 | Completed DMC

• 1 other identifier: 2013/980
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

Vertigo and dizziness.; semicircular canals

Outcome Measures

Primary Outcomes (1)

• Effect of change in velocity in treatment of lateral canal BPPV

  Two week cure rate

  Four years

Secondary Outcomes (1)

• Effect of change in velocity in treatment of lateral canal BPPV

  Four years

Study Arms (3)

Barbecue treatment without acceleration

ACTIVE COMPARATOR

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

Barbecue treatment with acceleartion

EXPERIMENTAL

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

Placebo treatment

PLACEBO COMPARATOR

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.

Device: Biaxial rotational chair

Interventions

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.

Also known as: TRV chair

Barbecue treatment with acceleartion; Barbecue treatment without acceleration; Placebo treatment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (1)

• 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.

  PMID: 32864448 DERIVED

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Vertigo; Dizziness

Condition Hierarchy (Ancestors)

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

Study Officials

• Camilla Martens, MD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Stein Helge Nordahl Glad

  Haukeland University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cand.med

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 23, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)