Trial document





This trial has been registered retrospectively.
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  DRKS00013921

Trial Description

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Title

Improvement of speech intelligibility in cochlear implant users with new sound processing strategies

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Aim of the study is to evaluate a new sound processing strategy for the Q70 sound processor of the HiRes90k cochlear implant (CI) by Advanced Bionics used in combination with the Phonak Naída™ Link UP hearing aid (HA) which is compatible with the CI's speech processor.

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Brief Summary in Scientific Language

With improvement of CI technology, more patients with residual hearing receive a CI while they continue use of a HA on their other ear (bimodal hearing). Despite benefits of bimodal hearing, speech intelligibility in noise remains difficult as CI exhibit poor transmission in the low frequencies and because CI and HA do not cooperate. If residual acoustic hearing that benefits from HA use is present, improvements in the transmission of low frequency information and in particular synchronization between electrically and acoustically-aided hearing may help to improve hearing performance in difficult listening conditions.
The Naída CI Q70 sound processor by Advanced Bionics and the Naída™ Link UP HA by Phonak have a common platform that allows integration of both devices. Aim of the study is to investigate, whether improvement of transmission of low frequency information by the sound processor of the CI together with better synchronization between CI and HA improves speech comprehension in noisy surroundings. Evaluation of speech intelligibility with conventional bimodal provision is performed at onset of the study. Assessment of the benefit of the experimental provision regarding speech intelligibility is performed at the end of the study, i.e. after continued use of the exprimental devices for 4 to 8 weeks.

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Organizational Data

  •   DRKS00013921
  •   2018/03/09
  •   [---]*
  •   yes
  •   Approved
  •   2017-578N-Ma, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   H91.8 -  Other specified hearing loss
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Interventions/Observational Groups

  •   Improvement of speech intelligibility by use of a new preprocessing algorithm in the CI in combination with a cooperating HA is investigated in bimodal patients with HiRes90k CI by Advanced Bionics and a contralateral hearing aid. For the study period participants use an experimental Naída Q70 spound processor together with a Naída™ Link UP hearing aid. Speech intelligibility with the experimental bimodal provision as compared to the conventional bimodal provision is tested at onset of the study and after a 4 to 8 week long adaptation interval. In addition to subjective tests (SSQ questionnaire, speech intelligibility tests) change in speech intelligibility is tested by recordings of auditory evoked potentials.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Improvement of subjectively perceived hearing performance in everyday listening situations recorded by the SSQ questionnaire (Speech, Spatial and Qualities of Hearing Scale, Gatehouse and Noble, 2004, Short German Version: Kiessling et al., 2011) with the experimental bimodal provision in comparison to the conventional bimodal provision.
Assessment of subjective hearing performance with the SSQ is performed at the start of the study, repeatedly during the study, and at the end of the study.

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Secondary Outcome

Improvement of speech intelligibility in noise as assessed with the Oldenburg sentence test (Wagener et al., 1999) between start and end of the study. Speech intelligibility is measured with the conventional bimodal provision at onset of the study and with the experimental bimodal provision at the end of the study.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/11/11
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

- highly hearing impaired patients with unilateral HiRes90k CI of the brand Advanced Bionics
- CI use for at least 12 month
- hearing aid use at contralateral ear
- native German speaker

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Exclusion Criteria

- more than mild cognitive impairment
- neurological or psychiatric conditions
- other implanted stimulators

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Hals-Nasen-Ohren-Klinik Universitätsklinikum Mannheim
    • Mr.  Dr. med.  Jerome  Servais 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Hals-Nasen-Ohren-Klinik, Universitätsklinikum Mannheim
    • Mr.  Dr.  Jerome  Servais 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Hals-Nasen-Ohren-Klinik, Universitätsklinikum Mannheim
    • Mr.  Dr.  Jerome  Servais 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Advanced Bionics AG
    • Mr.  Dr.  Josef  Chalupper 
    • Laubisrütistrasse 28
    • CH-8712  Stäfa
    • Switzerland
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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