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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01004913
Other study ID # kehila106/109
Secondary ID
Status Completed
Phase N/A
First received October 29, 2009
Last updated February 11, 2013
Start date November 2009
Est. completion date December 2011

Study information

Verified date August 2011
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Age 18-60 years

- Complaints of positional or positioning vertigo.

- Presence of typical nystagmus for posterior canal BPPV in Dix Hallpike maneuver

Exclusion Criteria:

- 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Otoneurology Unit, Lin Medical Center, 35 Rotchild Avenue Haifa

Sponsors (2)

Lead Sponsor Collaborator
Meir Medical Center Clalit Health Services, Haifa and West Galilee

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Other no other outcome measures no other outcome measure No
Primary Number of subjects with normal VEMP response At the time of diagnosis of BPPV No
Secondary Number of subjects with recurrent BPPV in whom VEMP response was pathological at the time of BPPV diagnosis No
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