Hearing Devices in Persons 50-90 Years old having a Hearing Loss of 50-90 dB.
Organizational Data
- DRKS-ID:
- DRKS00007567
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2015-01-02
- Last update in DRKS:
- 2015-01-02
- Registration type:
- Prospective
Acronym/abbreviation of the study
HD5090
URL of the study
No Entry
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.
Brief summary in scientific language
The HD5090 project
Health condition or problem studied
- ICD10:
- H90 - Conductive and sensorineural hearing loss
- ICD10:
- H91 - Other hearing loss
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
- Arm 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.
- Arm 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.
Endpoints
- 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.
- Secondary outcome:
- No Entry
Study Design
- Purpose:
- Prognosis
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Austria
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Other 4 HNO-Praxen (definitive Beteiligungszuage in 2015)
- Other 8 Hörakustiker (definitive Beteiligungszuage in 2015)
- Other 4 CI-Zentren (definitive Beteiligungszuage in 2015)
Recruitment period and number of participants
- Planned study start date:
- 2015-01-05
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 700
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 50 Years
- Maximum Age:
- 90 Years
- 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
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
Addresses
Primary Sponsor
- Address:
- Institut für Audiopädagogik - IfAPProf. Dr. Ir. Frans ConinxOhligser Markt 1142697 SolingenGermany
- Telephone:
- 0212-2335320
- Fax:
- 0212-2681443
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ifap.info
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für Audiopädagogik (IfAP)Profr. Dr. Ir. Frans ConinxOhligser Markt 1142697 SolingenGermany
- Telephone:
- 0212-2335320
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ifap.info
Contact for Public Queries
- Address:
- Institut für Audiopädagogik (IfAP)Profr. Dr. Ir. Frans ConinxOhligser Markt 1142697 SolingenGermany
- Telephone:
- 0212-2335320
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ifap.info
Principal Investigator
- Address:
- Institut für Audiopädagogik (IfAP)Profr. Dr. Ir. Frans ConinxOhligser Markt 1142697 SolingenGermany
- Telephone:
- 0212-2335320
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ifap.info
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- MEDELFürstenweg 77a7020 InnsbruckAustria
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät der Universität zu KölnGleueler Str. 26950935 KölnGermany
- Telephone:
- +49-221-478 82900
- Fax:
- +40-221-478 82905
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-11-21
- Ethics committee number:
- 14-380
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-12-17
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry