This research project has 2 main goals and can therefore be divided into 2 parts: - The aim of part (A) is to qualitatively and quantitatively assess the daily-life experiences of CI-patients who do or do not wear a contralateral hearing aid.…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the degree of bimodal benefit. This is the
benefit of wearing a CI in combination with a contralateral hearing aid
(bimodal listening) in comparison to only wearing a unilateral CI. Speech
understanding in difficult listening situations is still a main challenge for
hearing impaired and CI patients in daily life. Therefore speech understanding
in noise is considered to be the primary outcome of bimodal benefit.
- In part (A) the degree of bimodal benefit will be subjectively assessed using
two daily-life disability questionnaires (SSQ and AVETA).
- In part (B) the benefit of bimodal listening will be objectively measured on
speech understanding in quiet (CNC-score), spatial speech understanding in
noise (SSPINtest), listening effort (VAS-test) and the ability to localize
sounds (localization test).
See also: Research protocol: 7.1 Study parameters/endpoints.
Secondary outcome
- In part (A) the secondary parameters are the qualitative experiences of
CI-patients with or without a contralateral hearing aid, namely in the field of
hearing aid use (bimodal questionnaire) and sound quality (sound quality
questionnaire). Part (A) will also measure quality of life in this group of
bimodal and unilateral CI-patients by the use of a hearing specific
questionnaire (HHQ) and a general health questionnaire (HUI 3).
- Part (B) of the study focuses on the identification of more
objective-technical factors influencing the degree of bimodal success. Expected
contributors to bimodal benefit are
residual hearing, device fitting, loudness, spectral-, temporal information and
cognition. Therefore multiple secondary parameters will be measured in these
fields.
See also: Research protocol: 7.1 Study parameters/endpoints
Background summary
Since the 1990s, cochlear implantation (CI) has been the standard practice to
restore hearing in severely hearing-impaired and deaf patients by providing
multi-channel electrical stimulation to the auditory nerve. Current
reimbursement regulations in the Netherlands only allow standard unilateral
implantation. However, there is a growing interest in bilateral cochlear
implantation and in the benefits of binaural hearing (hearing with two ears) in
general. One way of providing binaural cues to unilateral CI recipients is to
wear an acoustic hearing aid in the contralateral non-implanted ear, known as
bimodal hearing.
The benefits of bimodal input (e. g. speech perception in noise, localisation,
listening effort) can objectively be demonstrated in clinical research
settings. However, in daily practice there are often patients who choose not to
wear their hearing aid (anymore) after receiving a CI in the other ear. Why
this is and how this can be improved is still an unanswered but very relevant
question in fitting and advising these patients in clinical practice.
See also: Research protocol: 1. Introduction and Rationale
Study objective
This research project has 2 main goals and can therefore be divided into 2
parts:
- The aim of part (A) is to qualitatively and quantitatively assess the
daily-life experiences of CI-patients who do or do not wear a contralateral
hearing aid. Assessing the subjective experiences of these patients is a
research area that hasn*t been covered in literature yet.
- The aim of part (B) is to identify the key contributors to successful bimodal
fitting. There is still little known about the reasons why patients may or may
not experience benefit from wearing a contralateral hearing aid.
After the assessment of these key contributors to bimodal success, a protocol
will be developed that may result in a faster and better bimodal fitting. In
future research these new insights may lead to clinical tools to create more
successful bimodal users with improved hearing performance. Moreover, the
results from this study will probably broaden the inclusion criteria for CI in
combination with HA, making it available for a larger population of patients.
See also: Research protocol: 2. Objectives
Study design
- In the first part of this study (A), unilateral CI-users will be asked to
fill out a set of relevant daily-life questionnaires in the field of hearing
experiences, sound quality and general quality of life. In this way their
subjective experiences with wearing or not wearing a hearing aid in the
contralateral ear will be reviewed.
- In the second part of this study (B), the subset of bimodal users will be
asked to partake in objective testing. The aim of this part is to investigate
correlations between the benefit of their bimodal fitting (e.g. speech-in-noise
and listening effort) and influencing factors (e.g. residual hearing, device
fitting, spectral- and temporal resolution and overlap, loudness balance and
cognitive skills).
See also: Research protocol: 3. Study design
Study burden and risks
Subjects participating in this study will be asked to fill out a set of
questionnaires (A) and/or perform audiological-specific tests (B). Study
associated risks are thought of as non-existent since this is an observational
study with non-invasive or low impact tests and no direct interventions.
Participation however takes time and effort from subjects: (A) 90 min
questionnaires, (B) ca 2.5 hours testing per visit, with a total of 2 visits.
The aim of the study is to identify key contributors to bimodal success. One
may expect that based on these results the clinical practice of unilateral CI
patients can be improved, both on an individual and on a group basis. The
clinical goal is to enable patients to successfully use CI and HA together,
receiving optimal benefit from their residual auditory abilities.
See also: Research protocol: 10.4 Benefits and risks assessment, group
relatedness
Rue de Battenheim 76
Rixheim 67180
NL
Rue de Battenheim 76
Rixheim 67180
NL
Listed location countries
Age
Inclusion criteria
- capacitated adult (>18 years of age)
- patient of CI-team South-East Netherlands
- user of a unilateral cochlear implant (CI) of the brand Advanced Bionics (AB)
- first fit CI >= one year ago
- wearing CI speech processor (almost) always (i.e. >=10 hours a day)
Part (A):
- willing and able to fill out questionnaires
- agreed to participate in this part of the study (by returning questionnaires)
Part (B):
- wearing a contralateral hearing aid >50% of the time (>=5 hours a day)
- willing and able to visit the azM and participate in testing
- agreed to participate in this part of the study (by informed consent)
Exclusion criteria
- non Dutch speaking
- < 18 years of age or incapacitated
- bilateral cochlear implant user (CI+CI)
Part (B), concerning Cone Beam CT-scan:
- pregnancy
- claustrophobia
- inability to sit still for longer than 30sec
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL42011.068.13 |
| OMON | NL-OMON21746 |