NCT01004913

Brief Summary

Benign Paroxysmal Positional Vertigo (BPPV) is the most frequent cause of vertigo of peripheral vestibular origin with life time incidence of 2.4%. BPPV is characterized by bouts of acute whirling vertigo lasting less than one minute provoked by changes in head position in relation to the gravitational vector. The vertigo is accompanied by typical rotational or horizontal nystagmus that is often demonstrated by the Dix-Hallpike maneuver and less frequently by testing for positional nystagmus. BPPV pathogenesis is currently explained by the fall of otoconia (calcium-carbonate crystals) or otoconial debris from the tectorial membrane of the otolithic organs into the dependant semicircular canals (canalithiasis) or adherence of such particles to the semicircular canal's cupula (cupulithiasis). Under these circumstances, the semicircular canal which normally responds only to angular velocity and acceleration is stimulated by gravity. Otoconial remnants as free floating particles inside the semicircular canal arms or attached to the cupula have been observed by few investigators. Although the presence of such particles explains most characteristics of the positioning nystagmus described in BPPV, it does not account for the dizziness and disequilibrium which are described by many patients even without changes in head position and the continuation of such symptoms after successful treatment of BPPV as evidenced by the resolution of positional vertigo and nystagmus. The study hypothesis is that otolithic pathology is an important component in the pathogenesis of BPPV explaining these symptoms, BPPV recurrence, and the refractoriness of some BPPV cases to the vastly employed particles repositioning treatments. In the present study the Vestibular Evoked Myogenic Potentials (VEMP) testing would be employed to measure the function of one of the otolithic organs - the saccule. The study objectives are: 1. To investigate possible malfunction of the saccule in patients suffering from BPPV. 2. To look for association between saccular pathology and BPPV recurrence and between such pathology and BPPV treatment failure. 3. To study possible relation between saccular pathology and continuation of dizziness and disequilibrium despite the resolution of positional vertigo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 12, 2013

Status Verified

August 1, 2011

Enrollment Period

2 years

First QC Date

October 29, 2009

Last Update Submit

February 11, 2013

Conditions

Keywords

Benign paroxysmal positional vertigoVestibular evoked myogenic potentialsSacculo-colic reflex

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with normal VEMP response

    At the time of diagnosis of BPPV

Secondary Outcomes (1)

  • Number of subjects with recurrent BPPV in whom VEMP response was pathological

    at the time of BPPV diagnosis

Other Outcomes (1)

  • no other outcome measures

    no other outcome measure

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering fron Benign Paroxysmal Positional Vertigo

You may qualify if:

  • Age 18-60 years
  • Complaints of positional or positioning vertigo.
  • Presence of typical nystagmus for posterior canal BPPV in Dix Hallpike maneuver

You may not qualify if:

  • Patient younger than 18 or older than 60 years of age.
  • Otoneurology bed-side examination reveals bilateral BPPV.
  • Audiometry and tympanometry show conductive hearing loss.
  • Signs of retrocochlear lesion or central vestibular pathology in bed-side otoneurological examination or audiometry or ENG/VNG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Otoneurology Unit, Lin Medical Center, 35 Rotchild Avenue

Haifa, 35152, Israel

Location

Related Publications (1)

  • Shupak A, Falah R, Kaminer M. Functional Integrity of the Inferior Vestibular Nerve and Posterior Canal BPPV. Front Neurol. 2020 Aug 26;11:894. doi: 10.3389/fneur.2020.00894. eCollection 2020.

MeSH Terms

Conditions

VertigoBenign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2009

First Posted

October 30, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

February 12, 2013

Record last verified: 2011-08

Locations