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Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Keimyung University Dongsan Medical Center
Sponsor:
Information provided by (Responsible Party):
HyunAh Kim, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier:
NCT02046980
First received: January 25, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

To determine the immediate therapeutic efficacies of Gufoni maneuver and mastoid oscillation in apogeotropic type of benign paroxysmal positional vertigo involving the horizontal semicircular canal (HC-BPPV), a randomized, prospective, sham-controlled study was conducted.


Condition Intervention Phase
Positional Vertigo
Procedure: Vibrator
Procedure: Gufoni
Procedure: Sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Keimyung University Dongsan Medical Center:

Primary Outcome Measures:
  • Conversion in direction of nystagmus from ageotropic to geotropic or disappearance of nystagmus [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 217
Study Start Date: September 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Gufoni
Gufoni maneuver for ageotrophic horizontal BPPV is performed and repeated after 24 hours if the initial treatment is not effective
Procedure: Gufoni Procedure: Sham
Sham Comparator: Vibration
Mastoid vibration is performed and repeated after 24 hours if the initial treatment is not effective
Procedure: Vibrator Procedure: Sham

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - complains positional vertigo
  • - ageotropic horizontal nystagmus on head turning test
  • - put one's signature on consent

Exclusion Criteria:

  • secondary BPPV due to migraine, meniere's disease, or trauma
  • spontaneous nystagmus, gaze evoked nystagmus, limb ataxia, severe imbalance, abnormal eye movement
  • combined vertical canal BPPV on Dix- Hallpike test
  • can not decide the direction of BPPV
  • cervical or lumbar spine problem
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02046980

Contacts
Contact: Sun Ah Bang 82-53-250-7845 sunavvvvv@naver.com

Locations
Korea, Republic of
Daegu Kyungbook Dizziness society Recruiting
Daegu, Korea, Republic of
Contact: Sun Ah Bang    82-53-250-7845      
Sponsors and Collaborators
Keimyung University Dongsan Medical Center
Investigators
Study Director: Hyun Ah Kim Daegu KyungBook Dizziness society
Study Chair: Hyung Lee Keimyung University Dongsan Medical Centerl
  More Information

No publications provided

Responsible Party: HyunAh Kim, Assistant Professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT02046980     History of Changes
Other Study ID Numbers: DK-0001
Study First Received: January 25, 2014
Last Updated: January 25, 2014
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Dizziness
Vertigo
Ear Diseases
Labyrinth Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms
Vestibular Diseases

ClinicalTrials.gov processed this record on November 24, 2014