Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

HC-BPPV Clinical Trial

— BPPV-HC  

Official title:

Randomized Multicenter Study of Treatment of Horizontal Canal Benign Paroxysmal Positional Vertigo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810641
• Other study ID #: KONOS
• Status: Completed
• Phase: Phase 3
• First received: December 17, 2008
• Last updated: May 31, 2011
• Start date: January 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Chonbuk National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

A randomized prospective study of patients with HC-BPPV. Patients with apogeotropic type of HC-BPPV were randomized to one of each three treatment groups at their first clinic visit. These groups included the Gufoni maneuver, head-shaking maneuver, and sham group in apogeotropic HC-BPPV. Responsiveness of treatment maneuver was determined by positioning maneuver immediately after each treatment method based on resolves of vertigo and positional nystagmus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• a history of brief episodes of positional vertigo,

• direction-changing horizontal nystagmus beating toward the uppermost (apogeotropic nystagmus) or undermost (geotropic nystagmus) ear in both the lateral head turning positions,

• no spontaneous nystagmus during upright sitting position, and

• absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus.

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HC-BPPV
• Vertigo

Intervention

Procedure:
• Gufoni maneuver
For Gufoni maneuver,16,18 the patient was quickly brought down to the side-lying position on the affected ear from the sitting position. After one minute in this position, the head of the patient was quickly turned 45O upward, so that the nose directed upward. Approximately 2 minutes later, the patient was returned to the upright position (Figure 2A).
• Head-shaking maneuver
For head-shaking maneuver,15 patients were brought into a sitting position. After pitching the head forward by approximately 30O, we moved the head sideways in a sinusoidal fashion at an approximate rate of 3 Hz for 15 seconds.
• sham maneuver
For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Cholabuk-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyoungki-do

Sponsors (2)

Lead Sponsor	Collaborator
Chonbuk National University	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial	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.	one hour	No