Trial document





This trial has been registered retrospectively.
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  DRKS00004967

Trial Description

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Title

Does the type of electrode used in cochlear implantation influence the occurrence of postoperative vertigo? A prospective study.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Our study called "Does the type of electrode used in cochlear implantation influence the occurence of postoperative vertigo? A prospective study." takes into account first-time implanted (The patients obtain a Cochlear implant which is an electric prosthesis for recovery of heraing) patients. They have been implanted at the medical school of hanover. After informed consent has been given to the patients, there have been 4 obejective clinical tests performed pre- and postoperatively. Furthermore the patients had to fill out a questionnaire concerning subjective vertigo symptoms. These data has been evaluated. The data has been anonymized.
As the tests has been performed pre- and postoperatively whlie routine appointments, there have not been additional appointments for the patients.
In the article there are no names of patients. They are just called #number.


The aim of this study was to find wheter there is an influence of different parameters of electrodes - width, length and form - on the vestibular injury and the occurence of subjective vertigo.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004967
  •   2013/05/10
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  •   yes
  •   Approved
  •   1740-2013, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   Vertigo after Cochlear implantation
  •   H81.8 -  Other disorders of vestibular function
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Interventions/Observational Groups

  •   In Patients with electrode A implanted have been performed clinical tests pre- and postoperatively as follows: Vestibular evoked myogenic potential (VEMP), caloric electronystagmography, posturography, subjective written vertical test. Furthermore the patients filled out a questionnaire gathering subjective vertigo symptoms. This electrode has been classified as long, thick and straight.
  •   Patients with electrode B implanted have been performed clinical tests pre- and postoperatively as follows: Vestibular evoked myogenic potential (VEMP), caloric electronystagmography, posturography, subjective written vertical test. Furtehrmore the patients filled oout a questionnaire gathering subjective vertigo symptoms. This electrode has been classified as mid-length, thin and preformed.
  •   Patients with electrode C implanted have been performed clinical tests pre- and postoperatively as follows: Vestibular evoked myogenic potential (VEMP), caloric electronystagmography, posturography, subjective written vertical test. Furtehrmore the patients filled oout a questionnaire gathering subjective vertigo symptoms. This electrode has been classified as long, thick and preformed.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Vestibular injury has been measured by objective measurements (VEMP, caloric, posturography, subjective vertical written test) and evaluated in correlation with the electrode implanted.
A questionnaire has been gathering subjective vertigo symptoms.

Both has been performed a few days preoperatively and 6 weeks postoperatively.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/08/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

first-time implanted CI patients

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Exclusion Criteria

Implantation of the second CI

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr.  Burkard  Schwab 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Boris  Wieselmann 
    • Carl-Neuberg-Straße 1
    • 30165  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Boris  Wieselmann 
    • Carl-Neuberg-Straße 1
    • 30165  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Hochschule Hannover
    • Mr.  Boris  Wieselmann 
    • Carl-Neuberg-Straße 1
    • 30165  Hannover
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/01/15
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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.