Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

NCT01366430 | Completed Phase 3

• 1 other identifier: Treatment of HC BPPV
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study was to compare the immediate efficacies of each treatment maneuvers in treatment of geotorpic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

BPPV(benign paroxysmal positional vertigo); HC-BPPV(BPPV involving the horizontal semicircular canal); Nystagmus; Treatment outcome; Horizontal Canal Benign Paroxysmal Positional Vertigo

Outcome Measures

Primary Outcomes (1)

• Immediate therapeutic effects for the treatment of geotropic HC-BPPV

  The immediate treatment response was determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus was required to determine a resolution. When the patient still showed positioning nystagmus or vertigo, the patient received the previously applied maneuver again.

  one hour

Study Arms (3)

Gefoni manenuver

ACTIVE COMPARATOR

Gefoni manenuver for Geotropic HC-BPPV

Procedure: Gufoni

sham maneuver

ACTIVE COMPARATOR

sham maneuver for geotropic HC-BPPV

Procedure: Sham

barbecue maneuver

ACTIVE COMPARATOR

barbecue maneuver for geotropic HC-BPPV

Procedure: Barbecue

Interventions

Gufoni PROCEDURE

For Gufoni maneuver, the patient was quickly brought down on the healthy side from the sitting position, and the head was then turned about 45 degree down, so that the nose was on the bed. After 2 minutes in this position, the patient was returned to the upright position.

Gefoni manenuver

Sham PROCEDURE

The sham maneuver the opposite of the first step for barbecue rotation; lying down from sitting position for 30 seconds, and head turn 90degree to the affected side for 1 minute, and then sit up.

sham maneuver

Barbecue PROCEDURE

For barbecue rotation, the head was rotated rapidly 90degree while supine in the direction of the healthy ear, which was immediately followed by a truncal rotation of 90degree in the same direction to lie on the intact side. After 30-60 seconds when the induced nystagmus was dissipated, the patients were subjected to a further 90degree rotation of the head and trunk en block in the same direction to attain the nose-down position. After a further 30-60 seconds, the head was again turned in the same direction so that the affected ear was downward. Finally, after another 30-60s, the patient was brought to sitting position. Only one maneuver was performed per session.

barbecue maneuver

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• a history of brief episodes of positional vertigo, direction-changing horizontal nystagmus beating toward the uppermost (apogeotropic nystagmus) ear in both the lateral head turning positions,
• no spontaneous nystagmus during upright sitting position
• absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus

You may not qualify if:

• central positional nystagmus with identifiable CNS lesions that could explain the positional nystagmus

Sponsors & Collaborators

• Chonbuk National University: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (3)

Chonbuk National University Hospital

Jeonju, Cholabuk-do, 560-712, South Korea

Location

Chonnam National University Hospital

Kwangju, Cholanam-do, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Nystagmus, Pathologic

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 6, 2011
• Study Start: January 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 6, 2011

Record last verified: 2009-01

Locations

KR (3)