Trial document




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  DRKS00009560

Trial Description

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Title

Retrospective evaluation of inner ear function and benefits after cochlea implantation

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Trial Acronym

I-pCI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim is a retrospective investigation of the inner ear function (hearing and vestibular function) and of benefits after cochlea implantation.

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Brief Summary in Scientific Language

The primary aim is a retrospective evaluation of inner ear function (residual hearing and vestibular function) after cochlea implantation. The secondary aims are a retrospective determination of influence criteria’s regarding inner ear function after cochlea implantation and a determination of subjective and objective benefits and disorders after cochlea implantation

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Organizational Data

  •   DRKS00009560
  •   2015/10/23
  •   [---]*
  •   yes
  •   Approved
  •   KEK-ZH 2015-0430, Kanton Zürich Kantonale Ethikkommission Zürich - Schweiz
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Secondary IDs

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

  •   H81 -  Disorders of vestibular function
  •   H83 -  Other diseases of inner ear
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Interventions/Observational Groups

  •   Retrospective evaluation of questionnaires (dizziness handicap inventory (DHI), vertigo symptom scale (VSS), QoL, Tinnitus questionnaire), postoperative audiograms (hearing thresholds) and pre- and postoperative vestibular test (eye tracking, vestibulo-ocular reflex, dynamic visual acuitiy test, Vestibular Evoked Myogenic Potentials, gender, age at implantation, duration of hearing loss or deafness, surgery date, side of implantation, surgical access, audiogram type, electrode array type, etiology of hearing loss, secondary diagnosis, existing subjective medical disorders, hearing sores with cochlea implant, postoperative medical disorders
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary aim is a retrospective evaluation of inner ear function (residual hearing and vestibular function) after cochlea implantation. This means a comparison of pre- and postoperative audiograms (hearing thresholds) and pre- and postoperative vestibular function testing (eye tracking, vestibulo-ocular reflex, dynamic visual acuitiy test, vestibular evoked myogenic potentials).

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Secondary Outcome

Retrospective determination of influence criteria’s regarding inner ear function after cochlea implantation and Retrospective determination of subjective and objective benefits and disorders after cochlea implantation.
This means evaluation of questionnaires (dizziness handicap inventory (DHI), vertigo symptom scale (VSS), QoL, Tinnitus questionnaire), postoperative audiograms (hearing thresholds) and pre- and postoperative vestibular test (eye tracking, vestibulo-ocular reflex, dynamic visual acuitiy test, Vestibular Evoked Myogenic Potentials, gender, age at implantation, duration of hearing loss or deafness, surgery date, side of implantation, surgical access, audiogram type, electrode array type, etiology of hearing loss, secondary diagnosis, existing subjective medical disorders, hearing sores with cochlea implant, postoperative medical disorders

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/10/10
  •   650
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   100   Years
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Additional Inclusion Criteria

Patient wih implanted cochlea Implantat system

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Exclusion Criteria

Uncomplete medical history

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Addresses

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    • UniversitätsSpital ZürichKlinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie
    • Mr.  Prof. Dr. med.  Alexander  Huber 
    • Frauenklinikstr. 24
    • 8091  Zürich
    • Switzerland
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    • UniversitätsSpital ZürichKlinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie
    • Mr.  PhD  Flurin  Pfiffner 
    • Frauenklinikstr. 24
    • 8091  Zürich
    • Switzerland
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    • UniversitätsSpital ZürichKlinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie
    • Mr.  PhD  Flurin  Pfiffner 
    • Frauenklinikstr. 24
    • 8091  Zürich
    • Switzerland
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Sources of Monetary or Material Support

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    • UniversitätsSpital ZürichKlinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie
    • Mr. 
    • Frauenklinikstr. 24
    • 8091  Zürich
    • Switzerland
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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