Trial document




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  DRKS00007567

Trial Description

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Title

Hearing Devices in Persons 50-90 Years old having a Hearing Loss of 50-90 dB.

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Trial Acronym

HD5090

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URL of the Trial

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Brief Summary in Lay Language

With increasing age persons typically develop a hearing impairment. The use of hearing devices can compensate the negative consequences of such hearing loss.
Possible Hearing Devices are acoustical hearing aids and cochlear implants.

So far, no reference values are available that provide the possibility to compare the (expected) auditory skills with different Hearing Devices, depeding on age and degree of hearing loss.

The main aim of the HD5090 Project is to collect these reference data in a multilingual context.

The scientific potential and quality of the HD5090 test profile (test battery) is very important. At the same time this test battery should be very practical and feasible to be used in a clinical practice.

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Brief Summary in Scientific Language

The HD5090 project

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Organizational Data

  •   DRKS00007567
  •   2015/01/02
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  •   yes
  •   Approved
  •   14-380, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1164-5388 
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Health Condition or Problem studied

  •   H90 -  Conductive and sensorineural hearing loss
  •   H91 -  Other hearing loss
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Interventions/Observational Groups

  •   Patients with Hearing Aid(s) in the test Group "HA": one single measurement using the HD5090 Profile.
    This Profile contains a questionnaire and mainly a few adaptive tests that measure auditory skills at various Levels: pure tone detection, word recognition thresholds in quiet and in noise, phoneme recognition and cognitive skills involved in word reading.
  •   Patients with Cochlear Implant(s) in the test Group "CI": one single measurement using the HD5090 Profile.
    This Profile contains a questionnaire and mainly a few adaptive tests that measure auditory skills at various Levels: pure tone detection, word recognition thresholds in quiet and in noise, phoneme recognition and cognitive skills involved in word reading.
  •   Persons not using any Hearing Device in the test Group "reference": one single measurement using the HD5090 Profile.
    This Profile contains a questionnaire and mainly a few adaptive tests that measure auditory skills at various Levels: pure tone detection, word recognition thresholds in quiet and in noise, phoneme recognition and cognitive skills involved in word reading.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Prognosis
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

All participants will be tested only once with the HD5090 Profile.
This Profile contains a questionnaire and mainly a few adaptive tests that measure auditory skills at various Levels: pure tone detection, word recognition thresholds in quiet and in noise, phoneme recognition and cognitive skills involved in word reading.

Data from participants (aged 50 to 90 years) who are wearing Hearing Aids or Cochlear Implants are included in the categories "Hearings Aids" and "Cochlear Implants".
Additionally, participants in the Age range 50-90 years who are not wearing a Hearing device will be tested as well. These data are used for controll i.e. reference purposes.

Tests are performed only once by the own Hearing Aid Acoustician, ENT-docotr or CI-Center.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • other 
  • other 
  • other 
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Recruitment

  •   Planned
  •   2015/01/05
  •   700
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Age ca. 50-90 years.
Test groups: user of a Hearing device (Hearing Aid and/or CI)
Controll Group: not using a Hearing Device

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Exclusion Criteria

- participant has no or very limited German language skills. Hearing tests based on German language can not be performed
- cognitive functioning is low and not enough to run the HD5090 test profile

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Addresses

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    • Institut für Audiopädagogik - IfAP
    • Mr.  Prof. Dr. Ir.   Frans  Coninx 
    • Ohligser Markt 11
    • 42697  Solingen
    • Germany
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    • Institut für Audiopädagogik (IfAP)
    • Mr.  Profr. Dr. Ir.  Frans  Coninx 
    • Ohligser Markt 11
    • 42697  Solingen
    • Germany
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    • Institut für Audiopädagogik (IfAP)
    • Mr.  Profr. Dr. Ir.  Frans  Coninx 
    • Ohligser Markt 11
    • 42697  Solingen
    • Germany
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Sources of Monetary or Material Support

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    • MEDEL
    • Fürstenweg 77a
    • 7020  Innsbruck
    • Austria
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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