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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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21 June 2021 |
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Main ID: |
DRKS00016778 |
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Date of registration:
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02/07/2020 |
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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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Sound quality assessment in cochlear implant and hearing aid users
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Scientific title:
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Sound quality assessment in cochlear implant and hearing aid users - SQ_CI |
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Date of first enrolment:
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24/08/2020 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://www.drks.de/DRKS00016778 |
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Study type:
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interventional |
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Study design:
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Allocation: Other;. Masking: Open (masking not used). Control: Other. Assignment: Other. Study design purpose: Treatment;
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Hartmut
Meister |
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Address:
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Geibelsr. 29-31
50931
Köln
Germany |
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Telephone:
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+49 221-47897003 |
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Email:
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hartmut.meister@uni-koeln.de |
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Affiliation:
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Jean Uhrmacher Institute for Clinical ENT-Research and Clinic of Otorhinolaryngology, Head and Neck Surgery, University of Cologne |
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Name:
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Hartmut
Meister |
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Address:
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Geibelsr. 29-31
50931
Köln
Germany |
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Telephone:
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+49 221-47897003 |
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Email:
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hartmut.meister@uni-koeln.de |
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Affiliation:
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Jean Uhrmacher Institute for Clinical ENT-Research and Clinic of Otorhinolaryngology, Head and Neck Surgery, University of Cologne |
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Key inclusion & exclusion criteria
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Inclusion criteria: Individuals provided with CI/HA. Individuals with normal hearing as “control group”. Since speech tests are also performed sufficient German language skills are mandatory.
Exclusion criteria: Insufficient German language skills, insufficient residual hearing on non-implanted ear, known cognitive dysfunctions
Age minimum:
18 Years
Age maximum:
no maximum age
Gender:
Both, male and female
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Health Condition(s) or Problem(s) studied
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H90.3 - Sensorineural hearing loss, bilateral
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H90.5 - Sensorineural hearing loss, unspecified
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Intervention(s)
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Intervention 1: Patients with Cochlear Implants (and Hearing Aid): sound quality assessment, psychoacoustic examination of underlying acoustic cues, corresponding CI/HA fitting (3 appointments). Additionally assessment of speech understanding and questionnaires regarding sound quality. Intervention 2: Patients with normal hearing as “control group”. CI signal processing is simulated by vocoding, hearing aid processing by compression and low-pass filtering. Examination of acoustic cues relevant for sound quality. One appointment.
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Primary Outcome(s)
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Rating scores for various sounds with systematically varied acoustic characteristics.
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Secondary Outcome(s)
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Questionnaire data, pure tone and speech reception thresholds, basic psychoacoustic measures.
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Source(s) of Monetary Support
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Cochlear Deutschland GmbH & Co KG
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Jean Uhrmacher Stiftung
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Ethics review
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Status: approved
Approval date: 13/02/2019
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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