To measure detection thresholds, loudness, and melody perception in CI recipients in order to assess extent of nerve degeneration between good and poor performers with respect to speech perception.
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
difference between CI recipients with high and poor performance, with respect
to detection thresholds, tone-decay time, melody recognition scores, and pulse
rate detection limits.
Secondary outcome
• To determine the range of test outcomes and clinical applicability for the
three developed tests.
• To determine if the outcome of the Melody test correlates to musical
background.
Background summary
Profound sensorineural hearing loss, or deafness, is caused by loss of sensory
hair cells in the cochlea. In many cases, it is treated by cochlear
implantation. A cochlear implant (CI) bypasses the hair cells in the cochlea.
Via electrical currents the implant stimulates the auditory nerve, which
results in the perception of sound. The CI provides some degree of auditory
perception, and in the most successful cases leads to virtually normal speech
perception in low-noise acoustic conditions. However, there is a wide spread in
performance among CI recipients, one contributing factor is auditory nerve
degeneration. Common clinical tests do not provide an adequate measure of
auditory nerve status. In order to assess nerve degeneration we developed three
different psychophysical tests for CI recipients. These tests are used to
determine detection thresholds, loudness adaptation and pitch perception. In
this protocol we refer to them as T-Békésy test, tone-decay test, and
Melody-test. It is hypothesized that nerve functionality tested in this way,
provides measures that correlate to nerve degeneration. Such measures, acquired
right after implantation, could be used for diagnosis, to improve the CI
fitting process (setting of the various apparatus parameters), and might lead
to new processing strategies that make voices and music sound more natural to
CI recipients.
Study objective
To measure detection thresholds, loudness, and melody perception in CI
recipients in order to assess extent of nerve degeneration between good and
poor performers with respect to speech perception.
Study design
This is an observational pilot study performed at the University Medical Center
Utrecht.
Study burden and risks
The T-Békésy test, tone-decay test and Melody test are considered as a
negligible-risk investigation since the current levels applied are not higher
than used in daily conditions of usage. The expected burden due to
participation for all participants consists of two sessions of approximately
120 and 80 minutes, respectively. The physical discomfort is comparable to what
CI recipients endure in the routine clinical fitting process. Subjects will not
have a direct benefit of this study. The results of this study will contribute
to knowledge of the clinical applicability of the developed tests for assessing
nerve degeneration in deaf patients with a cochlear implant, and could possibly
be linked to 'Assessment of the condition of the auditory nerve by diffusion
tensor imaging: A pilot study' (METC 13/493).
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
Subjects eligible for participation in the study are adults with a CI.;In order to be eligible to participate in this study, a subject must meet all of the following criteria:
o Age >=18 years.
o Unilaterally implanted.
o Capable to provide an informed consent.
o The type of CI must be supported by the test equipment. Therefore only CI recipients with PULSARci100 or SONATAti100 implant, manufactured by MED-EL, can be included.
o More than half a year of CI experience (6 month post implantation).;Additional criterion for the high performance group:
o CVC scores with CI >70% measured at 65 dB SPL;Additional criterion for the low performance group:
o CVC scores with CI <50% measured at 65 dB SPL
Exclusion criteria
• Neurological or mental disorders
• Use of anticonvulsant medication or psychotherapeutic drugs
Design
Recruitment
Medical products/devices used
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 | NL46946.041.13 |