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Completed

NCT Number: NCT00810641

Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

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).

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Key information

Conditions

HC-BPPV Benign Paroxysmal Positional Vertigo Cranial Nerve Diseases Ear Diseases Eye Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Nystagmus, Pathologic Ocular Motility Disorders Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chonbuk National University Hospital, Jeonju, Cholabuk-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gufoni maneuver

Procedure

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

Procedure

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

Procedure

For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.

Primary outcomes

  1. Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial

    Time frame: one hour

    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.

Sponsors and collaborators

Lead sponsor

Chonbuk National University

Other

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study title

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

Acronym: BPPV-HC

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 18, 2008
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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