The main objective of this study is to assess the effectiveness of an integrated program of fitting and training interventions aimed at reducing unexpected variability and addressing the specific error patterns of each recipient.
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the level of improvement of phoneme and word
recognition score on the individual scale after the interventions.
Secondary outcome
The secondary endpoints are:
1. the results of the exploratory analyses performed on the correlation between
the spectrotemporal assessment test and the subjects* error profile.
2. the results of the exploratory analyses performed on the differences between
error patterns in phoneme and word recognition tests, both between and within
subjects.
3. The results of the SUS/IMI questionnaires concerning the individualized
training app
Background summary
Some adult Cochlear Implant recipients have markedly poorer speech recognition
scores than what can be expected from the known predictive factors. This study
aims to better understand what type of errors in speech understanding is being
made by those users and what tests are sensitive for mapping out user-specific
error patterns. The ultimate aim of the AuDiET study is to pave the way to
novel, innovative fitting and training interventions which could help improve
the performance of CI recipients.
Study objective
The main objective of this study is to assess the effectiveness of an
integrated program of fitting and training interventions aimed at reducing
unexpected variability and addressing the specific error patterns of each
recipient.
Study design
Pre-post study design
Intervention
Two distinct interventions are planned for the lower performing CI users, one
concerning adjustments to their CI fitting and one concerning personalized
auditory training.
Study burden and risks
Study subjects will undergo a number of non-invasive tests, some of the tests
are standard audiometric tests part of routine clinical visits such as Tonal
Audiometry and Speech Audiometry, others are specific phoneme recognition tests
or psychophysical tests measuring spectral and/or temporal acuity. Due to the
number of measurements needed, the subject may experience fatigue: the tests
will be accordingly spread out and there will be opportunities to rest and
recover. We foresee no risks associated with this study.
Oude Graafseweg 271
Nijmegen 6543PP
NL
Oude Graafseweg 271
Nijmegen 6543PP
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
* Adult (over 18 years old at the time of inclusion)
* Post-lingually deafened (the subject had a good mastery of spoken language
before onset of deafness)
* Native Dutch speaker
* Implanted, either unilaterally or bilaterally, with a Cochlear Implant
manufactured by Cochlear Ltd (i.e., a Nucleus ® implant).
* Implanted with one of the following implants: CI422, CI512, CI522, CI532,
CI24R, CI24RE.
* Implanted for at least 12 months.
Exclusion criteria
A potential subject for the CI user group who meets any of the following
criteria will be excluded from participation in this study:
* Known abnormally formed cochlea
* Known pre-implantation ossification of the cochlea
* Severe cognitive disorders affecting their ability to understand spoken
language
* Intense facial nerve stimulation
* Unaddressed electrode tip foldover
* More than 4 electrodes deactivated because of malfunction (open/short
circuit) or lack of response
* Additional illnesses or handicaps that could impact the ability to
participate in the study, at the clinician*s discretion.
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 | NL80521.091.22 |