NCT01822002

Brief Summary

To determine the immediate therapeutic efficacies of canalith repositioning maneuvers in each type of BPPV (posterior canal type, apogeotropic horizontal canal type and geotropic horizontal canal type).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 1, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

March 25, 2013

Last Update Submit

March 29, 2013

Conditions

Keywords

VertigoNystagmusBPPV = benign paroxysmal positional vertigoTreatment outcome

Outcome Measures

Primary Outcomes (1)

  • efficacy of repositioning maneuvers for treating PC-BPPV

    The immediate treatment response will be 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 will be required to determine a resolution.

    2hr

Study Arms (2)

Canalith repositionig maneuver; Epley maneuver group

ACTIVE COMPARATOR

Patients with PC-BPPV will be randomly assigned to Epley maneuver or Semont maneuver.

Procedure: Canalith repositioning maneuver

Canalith repositioning maneuver : Semont maneuver group

ACTIVE COMPARATOR

Patients with PC-BPPV will be randomly assigned to Epley maneuver or Semont maneuver group.

Procedure: Canalith repositioning maneuver

Interventions

Also known as: Epley maneuver, Semont maneuver
Canalith repositionig maneuver; Epley maneuver groupCanalith repositioning maneuver : Semont maneuver group

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • a history of positional vertigo
  • upbeating-torsional nystagmus in Dix-Hallpike maneuver
  • absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus.

You may not qualify if:

  • (1) Patients with positive neurotological examinations including spontaneous and gaze-evoked (GEN) nystagmus, horizontal and vertical smooth pursuit and saccades, limb ataxia, and balance function in addition to routine neurological examinations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk National University Hospital

Jeonju, 561 781, South Korea

RECRUITING

Related Publications (1)

  • Oh SY, Kim JS, Choi KD, Park JY, Jeong SH, Lee SH, Lee HS, Yang TH, Kim HJ. Switch to Semont maneuver is no better than repetition of Epley maneuver in treating refractory BPPV. J Neurol. 2017 Sep;264(9):1892-1898. doi: 10.1007/s00415-017-8580-2. Epub 2017 Jul 28.

MeSH Terms

Conditions

Benign Paroxysmal Positional VertigoVertigoNystagmus, Pathologic

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOcular Motility DisordersCranial Nerve DiseasesEye Diseases

Central Study Contacts

Sun-Young Oh, MD

CONTACT

Hyo-Jeong Kim

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 25, 2013

First Posted

April 1, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2015

Last Updated

April 1, 2013

Record last verified: 2013-03

Locations