The main objective of the study is to better explain disappointing speech recognition in individual cases, with as ultimate goal to find optimal individual settings for the sound processor (outside the scope of this project). We test two new methods…
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are the differences in response between pairs of
CI electrodes. The response in case of the EEG measurement (passive task) is
the neural power at frequencies of interest, determined by the two stimulation
patterns of the two CI electrodes. For the reaction-time method (active task),
the response is the manual response-reaction-time to a perceived change in the
sound.
Secondary outcome
The secondary study parameter is the correlation between outcomes of the speech
and spectro-temporal modulation tests as determined with the App and with the
standard lab test methods.
Further study parameters are the electrode impedances and eCAPs.
Background summary
Cochlear implant (CI) users display a considerable and largely unexplained
variability in speech recognition: some users reach more than 80% word
recognition scores, for others, scores are disappointingly low (e.g., 50% or
less). The variability is even increased in noisy environments. Possible
sources of this variability are multifold. These can be device-related, for
example, differences in the precise locations of CI electrodes in the cochlea,
and interference between electrodes because of overlapping auditory nerve
populations, together with suboptimal individual settings of the sound
processor. Alternatively, or in addition, the cause of variability may be
subject-related, for example degeneration of the auditory nerve, deficiencies
in the more central auditory processing, or cognitive factors. Spectro-temporal
resolution seems to be an important factor in speech recognition. We
investigate two new methods to measure the spectro-temporal resolution,
including * in a controlled way - the impact of CI electrode interactions on
the processing of temporal and spectral information. Two CI electrodes will be
stimulated simultaneously employing basic pulse patterns. The response of the
auditory system to this known input is then measured either with EEG, without
any active involvement of the subject, or with a simple, but information-rich,
reaction-time task, designed to largely eliminate cognitive factors.
Study objective
The main objective of the study is to better explain disappointing speech
recognition in individual cases, with as ultimate goal to find optimal
individual settings for the sound processor (outside the scope of this
project). We test two new methods to measure spectro-temporal resolution on
electrode-level, excluding influences of the sound processor and largely
excluding cognitive influences. Results will be compared to results with a more
conventional spectro-temporal test including the sound processor, and with
speech recognition tests.
The secondary objective is to evaluate an App for obtaining data. Being able to
perform a part of the measurements at home is now more relevant than ever.
Further we aim to contribute to disentangling the impact of the above-mentioned
sources of variability on speech recognition.
Study design
This is an explorative study with between-subject and within-subject
comparisons. Outcomes will be compared with speech recognition results and with
standard objective measures as electrode impedance and electrically evoked
compound action potentials (eCAPs), an indication of the response of the
auditory nerve.
Study burden and risks
Full participation involves three visits to Nijmegen, each with a duration of 3
hours. The third visit is only necessary for the participants in the EEG
measurements (10 of the 16 subjects). In addition, all subjects will be asked
to perform measurements at home using an App, this will in total take about 10
hours. Measurements are non-invasive and have negligible risks. EEG devices
employed in this study are CE approved. The research interface used for the CI
stimulation in a part of the measurements, although not CE approved, guarantees
electrical current levels below physiological safety limits, and has low risk,
as described in the attached investigational medical device dossier. There will
be no direct benefit for the participants.
Heyendaalseweg 135
Nijmegen 6525 AJ
NL
Heyendaalseweg 135
Nijmegen 6525 AJ
NL
Listed location countries
Age
Inclusion criteria
* Healthy
* Aged 18 or older and mentally competent
* Unilateral CI wearers with a CII or HiRes family implant manufactured by
Advanced Bionics.
* Native Dutch speaker
* Written informed consent
Exclusion criteria
* Disability which could interfere with the completion of the tests (e.g.,
psychiatric problems).
* For the EEG measurement: a subject with very thick hair or a skin condition
on the skull which makes the skin extremely sensitive.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL74369.091.20 |