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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00007567 |
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Date of registration:
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02/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Hearing Devices in Persons 50-90 Years old having a Hearing Loss of 50-90 dB.
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Scientific title:
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Hearing Devices in Persons 50-90 Years old having a Hearing Loss of 50-90 dB. - HD5090 |
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Date of first enrolment:
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05/01/2015 |
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Target sample size:
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700 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00007567 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: Prognosis
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Phase:
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Countries of recruitment
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Austria
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Germany
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Contacts
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Name:
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Frans
Coninx |
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Address:
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Ohligser Markt 11
42697
Solingen
Germany |
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Telephone:
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0212-2335320 |
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Email:
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f.coninx@ifap.info |
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Affiliation:
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Institut für Audiopädagogik (IfAP) |
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Name:
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Frans
Coninx |
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Address:
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Ohligser Markt 11
42697
Solingen
Germany |
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Telephone:
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0212-2335320 |
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Email:
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f.coninx@ifap.info |
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Affiliation:
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Institut für Audiopädagogik (IfAP) |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
50 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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H90
H91
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Conductive and sensorineural hearing loss
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Other hearing loss
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Intervention(s)
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Group 1: 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.
Group 2: 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.
Group 3: 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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Primary Outcome(s)
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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 ID(s)
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U1111-1164-5388
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Source(s) of Monetary Support
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MEDEL
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Ethics review
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Status: Approved
Approval date: 17/12/2014
Contact:
gs-ek@uni-koeln.de
Ethikkommission der Medizinischen Fakultät der Universität zu Köln
+49-221-478 82900
gs-ek@uni-koeln.de
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