Comparison of hearing preservation and outcome of two fundamentally different cochlear implants designs (LW or PM) and the two most used surgical approaches (RW or CO). Secondly, asses the structure preservation (i.e., scalar position) of each…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
- Surigical procedure
N.a.
Outcome measures
Primary outcome
<p>Hearing preservation is the main outcome, which will be expressed in<br />
percentage. Hearing preservation is calculated by using the preoperative and<br />
postoperative puretoneaudiometry (PTA). </p>
Secondary outcome
<p>Scalar position of the electrode array (scala tympani or scala vestibuli<br />
assessed by CB-CT), ECochG (among others amplitude in µV) and eCAP (among<br />
others amplitude in µV) potentials, and speech perception test with/without<br />
noise in CVC words correct score (in percentage) with signal to noise ratio of<br />
10 dB. </p>
Background summary
In order to preserve the residual hearing in patients with sensorineural
hearing loss (SNHL) receiving a cochlear implant (CI), the insertion trauma to
the delicate and microscopic structures of the cochlea needs to be minimized.
The surgical procedure starts with the conventional mastoidectomy-posterior
tympanotomy (MPT) approach to the middle ear, and is followed by accessing the
cochlea, with either a cochleostomy (CO) or via the round window (RW). Both
techniques have their benefits and disadvantages. Another aspect is the design
of the electrode array. There are fundamentally two different designs: a
*straight* lateral wall lying electrode array (LW), or a *pre-curved*
perimodiolar cochlear lying electrode array (PM). Interestingly, until now, the
best surgical approach and type of implant is unknown. Our hypothesis is that
the combination of a RW approach and a LW lying electrode array minimizes
insertion trauma, leading to better hearing outcome for SNHL patients.
Study objective
Comparison of hearing preservation and outcome of two fundamentally different
cochlear implants designs (LW or PM) and the two most used surgical approaches
(RW or CO). Secondly, asses the structure preservation (i.e., scalar position)
of each combination of electrode design/surgical approach. Thirdly, find
objective electrophysiological measures for insertion trauma.
Study design
Randomized controlled single-blind trial consisting of four groups: I: RW and
LW, II: RW and PM, III: CO and LW and IV: CO and PM.
Intervention
Randomisation to one of the four groups.
Study burden and risks
Cone-beam CT (CB-CT) imaging postoperatively leads to exposure of low-dose
radiation (effective dose: 0.18 mSv), and is therefore considered to be of
low-risk.
IAML van Beurden
Heidelberglaan 100
Utrecht 3584 CX
Netherlands
+31 88 75 566 44
kno@umcutrecht.nl
IAML van Beurden
Heidelberglaan 100
Utrecht 3584 CX
Netherlands
+31 88 75 566 44
kno@umcutrecht.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
- Severe hearing loss, CI candidate
- 18 years of age or older
- normal function of middle ear (i.e. no acute middle ear infections)
- dutch language proficiency
- choice for Advanced Bionics implant
Exclusion criteria
- prior otologic surgery in the implanted ear (excluding tympanostomy tube
placement)
- inner ear malformation present in the ear to be implanted (i.e. ossification,
Mondini malformation)
- retrocochlear pathology present in the auditory system to be implanted
- neurocognitive disorders
- sudden deafness
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
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 | NL71233.041.19 |
Research portal | NL-006726 |