Trial document




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  DRKS00003365

Trial Description

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Title

Sense of taste in patients with acoustic neuromas

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Vestibular schwannomas (acoustic neuromas) are benign intracranial tumours.
The main sysmptoms are hearing impairment, disturbed sense of balance an tinnitus.
Additionally, the facial nerve and the sense of taste can be affected.
The aim of this study is to investigate this resluting taste deficit using the a validated taste test.
In patients with unilateral vestibular schwannomas the sense of taste is evaluated by taste strips. The four qualities of taste (sweet, sour, bitter and salyt) are tested side separately in the posterior and anterior part of the tongue and the results are compared with normative values.
The influence of age, gender and smoking is considerd. Additionally factors like the size of the tumour, function of the facial nerve and hearing impairment is analyzed.

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Brief Summary in Scientific Language

Vestibular schwannomas (acoustic neuromas) are benign intracranial tumours of the myelin-forming cells of the vestibulocochlear nerve.
Clinically, the main sysmptoms are hearing impairment, disturbed sense of balance an tinnitus.
Because of the narrow anatomic structures in the cerebellopontine angle and especially the internal auditory canal, the facial nerve and the nervus intermedius can also be affected.
Possible symptoms could be crocodile tears, dry eyes, facial palsy and a reduced sense of taste in the anterior parts of the tongue.
The aim of this study is to investigate this resluting taste deficit using the validated psychophysical Taste Strip test.
In patients with unilateral vestibular schwannomas diagnosed by an MRI, the sense of taste is evaluated by the Taste Strips. The four qualities of taste are tested side separately in the supply area of the Chorda tympani and the glossopharyngeal nerve and is compared with normative values.
The influence of age, gender and smoking is considerd. Additionally factors like the size of the tumour, function of the facial nerve and hearing impairment is analyzed.

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Organizational Data

  •   DRKS00003365
  •   2011/12/15
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  •   yes
  •   Approved
  •   837.296.03(3958), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   D33.3 -  Benign neoplasm: Cranial nerves
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Interventions/Observational Groups

  •   In patients with unilateral acoustic neuroma the sense of taste is investigated with Taste Strips
  •   historic healthy controls
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Historical
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Difference in Taste-Strip Score in patients with acoustic neuroma and normative data and differences in Taste-Strip Scores in ipsilateral and contralateral sides of the tumour

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Secondary Outcome

Differences of the different taste qualities (sweet, sour, bitter, salty) in patients with acoustic neuroma compared to normative data and differences of these qualities on the ipsilateral and contralateral side of the tumour in the patients.
Influece of gender, age, smoking habits, tumour size and general facial nerve function on the Taste Strip results.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/12/15
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

patients with unilateral acoustic neuroma diagnosed by MRI

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Exclusion Criteria

Taste disturbances due to other causes
previous operations of the middle ear / inner ear canal

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Addresses

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    • Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- Hals-Chirurgie der Universitätsmedizin der Johannes Gutenberg Universität Mainz
    • Mr.  Dr.med.  Boris  Haxel 
    • Langenbesckstr. 1
    • 55131  Mainz
    • Germany
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    • Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- Hals-Chirurgie der Universitätsmedizin der Johannes Gutenberg Universität Mainz
    • Mr.  Dr.med.  Boris  Haxel 
    • Langenbesckstr. 1
    • 55131  Mainz
    • Germany
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    • Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- Hals-Chirurgie der Universitätsmedizin der Johannes Gutenberg Universität Mainz
    • Mr.  Dr.med.  Boris  Haxel 
    • Langenbesckstr. 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/12/30
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Trial Publications, Results and other Documents

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