Speech Perception Performance With Gap-interleaved Stimulation Paradigms
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|ClinicalTrials.gov Identifier: NCT03937388|
Recruitment Status : Completed
First Posted : May 3, 2019
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Deafness Hearing Loss||Other: Cochlear stimulation strategy including time-fixed gaps||Not Applicable|
Auditory gaps can be induced in standard CI users by temporarily deactivating one to three electrodes. These gaps can be configured to have different gap durations.
The different variations of auditory stimulation with gaps will be presented to study participants via a standard MED-EL audio processor (Opus 2) bearing conformity marking. The programming of the processor will be performed using standard clinical hardware and software interfaces. These include the hardware interfaces "MAX interface box" and the "Diagnostic Interface Box" (DIB II) as well as the "MAESTRO" fitting software. After programming the respective configurations to the audio test-processor, a clinical word recognition test (Fournier) and a clinical consonant recognition test will be presented to the participants in a sound-shielded chamber using a free-field loudspeaker system.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Repeated measures, randomised, controlled, single blinded trial|
|Masking:||None (Open Label)|
|Official Title:||Effect of Gap-interleaved Stimulation Paradigms in Speech Perception Performance of Experienced Cochlear Implant Recipients: a Single-centre, Randomised Controlled Single-blinded Study|
|Actual Study Start Date :||March 6, 2019|
|Actual Primary Completion Date :||June 28, 2019|
|Actual Study Completion Date :||June 30, 2019|
|Experimental: Cochlear implant recipients||
Other: Cochlear stimulation strategy including time-fixed gaps
Investigation of the impact of time-fixed gaps (zero-stimulation periods) in the cochlear stimulation strategy on speech performance and hearing quality.
- Performance in standardized speech perception tests [ Time Frame: Day 1 ]Consonant and word recognition tests
- Comparison of volume levels resulting in equal loudness perception [ Time Frame: Day 1 ]Energetic efficiency of stimulation map
- Quality of hearing [ Time Frame: Day 1 ]1-10 visual-analog scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937388
|Geneva University Hospitals|
|Geneva, Switzerland, 1205|
|Principal Investigator:||Angelica Perez Fornos, PhD||University Hospital, Geneva|