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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: |
DRKS00010970 |
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Date of registration:
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12/08/2016 |
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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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Speech intelligibility in noise of bimodal cochlear implant users
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Scientific title:
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Speech intelligibility in noise of bimodal cochlear implant users - SPIN-BIM-CI |
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Date of first enrolment:
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01/09/2016 |
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Target sample size:
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20 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00010970 |
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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: basic science
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Phase:
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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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Tim
Jürgens |
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Address:
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Monkhöfer Weg 239
23562
Lübeck
Germany |
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Telephone:
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04513005261 |
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Email:
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tim.juergens@uni-oldenburg.de |
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Affiliation:
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Institut für Akustik, Technische Hochschule Lübeck |
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Name:
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Tim
Jürgens |
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Address:
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Monkhöfer Weg 239
23562
Lübeck
Germany |
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Telephone:
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04513005261 |
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Email:
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tim.juergens@fh-luebeck.de |
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Affiliation:
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Institut für Akustik, Technische Hochschule Lübeck |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Unilateral CI User
- CI user since at least half a year
- On the ear contralateral to the CI:
either wearing:
Hearing aid (hearing threshold better than 100 dB HL at 1 khz and better than 80 dB HL at 500 Hz)
or normal hearing (hearing threshold better than 30 dB HL between 250 Hz to 4 kHz).
Exclusion criteria: - Speech intelligibility using Cochlea implantat in quiet is poorer than 50%-correct at 65 dB SPL measured with German sentence test "Oldenburger Satztest".
- Subject younger than 18 years
- Subject has less than 6 months experience with their cochlea implantat.
- Subject has no residual hearing at the ear contralateral to the cochlea implantat.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hearing loss, unspecified
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H91.9
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H91.9
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Intervention(s)
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Group 1: Cochlear implant users, using hearing aid on the other ear side: assesment of speech intelligibility in different spatially arranged noise situations
Group 2: Unilateral cochlear implant users, normal hearing on the other side: assesment of speech intelligibility in different spatially arranged noise situations
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Primary Outcome(s)
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Assesment of speech intelligibility using a german sentence test (Oldenburger matrix test) of bimodal CI-Users in different spatial environments and signal-to-noise-ratios.
Assesment of spatial realease from masking (SRM = Benefit obtained by spatially separating speech and noise) and bimodal benefit.
(Difference in speech intelligibility for co-located and spatially separated conditions is calculated to obtain the SRM). Bimodal benefit is calculated by comparing speech intelligibility using CI alone with using CI and hearing aid.
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Secondary Outcome(s)
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Assesment of speech intelligibility of bimodal CI-users using different speech processing strategies.
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Source(s) of Monetary Support
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Deutsche Forschungsgemeinschaft
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Ethics review
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Status: Approved
Approval date: 08/08/2016
Contact:
med.ethikkommission@uni-oldenburg.de
Geschäftsstelle der medizinischen Ethikkommission, Fakultät VI Medizin und Gesundheitswissenschaften, Carl von Ossietzky Universität Oldenburg, Gebäude V04 (Raum 1-137)
+49-441-7983109
med.ethikkommission@uni-oldenburg.de
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