Trial document




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  DRKS00003302

Trial Description

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Title

Prospective investigations of vestibular evoked myogenic potentials (VEMP) in patients with benign paroxysmal positional vertigo (BPPV) in comparison with healthy subjects as a parameter for prognosis an success of therapy

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Trial Acronym

VEMP in patients with BPPV

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In the study should be investigated if VEMP (vestibular evoked myogenic potentials) could be a parameter of therapy success and a factor for prognosis in patients suffering from BPPV. This contains a comparison of VEMP between patients with BPPV and healthy subjects as well as before and after Dix Halpike or therapeutic manoeuvres.

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Brief Summary in Scientific Language

In a prospective, controlled, not randomized study should be investigated if amplitude and latency of VEMP of both sides could be useful as a parameter for prognosis and therapy in patients with BPPV.
Therefore VEMP of 100 patients suffering from BPPV are compared with 100 healthy subjects before and after Dix Hallpike or therapeutic manoeuvres.

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Organizational Data

  •   DRKS00003302
  •   2012/01/20
  •   [---]*
  •   yes
  •   Approved
  •   EK-BR-73/11-1, Ethikkommission bei der Sächsischen Landesärztekammer
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   H81.1 -  Benign paroxysmal vertigo
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Interventions/Observational Groups

  •   patients with BPPV:Comparison of the amplitudes and latencies of VEMP (vestibular evoked myogenic potentials) before and after Dix-Hallpike / Semont /Epley manoeuvre and between healthy persons and persons suffering from BPPV
  •   healthy subjects: Comparison of the amplitudes and latencies of VEMP (vestibular evoked myogenic potentials) before and after Dix-Hallpike / Semont /Epley manoeuvre and between healthy persons and persons suffering from BPPV
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Comparison of the amplitudes and latencies of VEMP (vestibular evoked myogenic potentials) before and after Dix-Hallpike / Semont /Epley manoeuvre

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Secondary Outcome

Comparison of the amplitudes and latencies of VEMP between healthy persons and persons suffering from BPPV

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/01/06
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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Additional Inclusion Criteria

Patients with BPPV: suspicion of BPPV, normal clinical findings in ear microscopy, age > 18y., no use of alcohol within 12h, no acute loss of hearing, no use of sedativa or neurotological drugs, no neurological diseases
Healthy subjects: no suspicion of acute vertigo and peripheral vestibular disease, normal clinical findings in ear microscopy, age > 18y., no use of alcohol within 12h, no acute loss of hearing, no use of sedativa or neurotological drugs, no neurological diseases

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Exclusion Criteria

Patients with BPPV and healthy subjects: conductive hearing loss > 10 dB, age > 70y., pregnancy, lactation, incompliance, drug and alcohol abuse

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Addresses

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    • HELIOS Klinikum Borna Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf-/Hals und plastische Gesichtschirurgie
    • Mr.  Dr. med.  Karsten  Koch 
    • Rudolf- Virchow-Strasse 2
    • 04552  Borna
    • Germany
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    • HELIOS Klinikum Borna Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf-/Hals und plastische Gesichtschirurgie
    • Mr.  Dr. med.  Karsten  Koch 
    • Rudolf- Virchow-Strasse 2
    • 04552  Borna
    • Germany
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    • HELIOS Klinikum Borna Klinik für Hals-, Nasen-, Ohrenheilkunde kopf- Hals- und plastische Gesichtschirurgie
    • Mr.  Dr. med.  Karsten  Koch 
    • Rudolf-Virchow-Strasse 2
    • 04552  Borna
    • Germany
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Sources of Monetary or Material Support

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    • HELIOS Resaerch Center (HRC) HELIOS Kliniken GmbH
    • Friedrichstrasse 136
    • 10117  Berlin
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.