To evaluate the effectiveness of bilateral implantation over unilateral implantation in children with severe-to-profound sensorineural hearing loss. Furthermore with this study we will investigate whether simultaneous bilateral implantation is…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the performance on the TAIT video analysis.
Secondary outcome
Secondary outcomes will be the performance on:
- soundlocalization tests
- auditory perception measures
- electrophysiology tests: Auditory brainstem response (ABR) and Cortical
auditory evoked potentials (CAEP)
Background summary
Several studies show that bilateral cochlear implantation seems to have an
added value compared to unilateral implantation in deaf children. However,
these studies are of poor quality, which caused that The Dutch Health Care
Insurance Board (College voor zorgverzekeringen) stated that there currently is
insufficient evidence regarding the suggested beneficial effect of bilateral
implantation over unilateral implantation and therefore they do not compensate
the second cochlear implant for young children with severe-to-profound
deafness. In order to provide conclusive evidence for bilateral cochlear
implantation we aim to conduct a randomized controlled trial comparing
simultaneous bilateral cochlear implantation with sequential bilateral
implantation in children with severe-to-profound deafness.
Study objective
To evaluate the effectiveness of bilateral implantation over unilateral
implantation in children with severe-to-profound sensorineural hearing loss.
Furthermore with this study we will investigate whether simultaneous bilateral
implantation is preferable to sequential bilateral implantation.
Study design
45 subjects with severe-to-profound sensorineural hearing loss will be included
in this Randomized Controlled Trial; 20 Subjects will be randomly allocated to
receive two cochlear implants simultaneously during one operation (Group A),
and the other 25 Subjects will be randomly allocated to receive one implant at
the beginning of the study and a second implant after a period of two years
(Group B). Both groups will be followed for 4 years after (the first)
implantation.
Intervention
Group A: bilateral simultaneous cochlear implantation
Group B: bilateral sequential cochlear implantation
Study burden and risks
For group A subjects: the duration of surgery will be prolonged with
approximately 50% of the standard operation time.
For group B subjects: the risks of the second surgery are considered equal to
the risks of the first surgery.
All participants will be asked for seven additional visits to the outpatient
clinic for additional evaluations. The duration of every visit will vary
between 1 and 1.5 hours.
All parents of participants will be asked at every visit to complete two
questionnaires. It takes approximately 15 minutes to complete the two
questionnaires.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
- Cochlear implant candidacy, according to the current criteria
- Age < 2 years
- Written informed consent by parents or guardians
- General health allowing general anaesthesia for the potential implantation of two cochlear implants during a single surgery.
- Patients covered by the Dutch health insurance
Exclusion criteria
- General health not allowing general anaesthesia for the potential implantation of two cochlear implants during a single surgery.
- Abnormal cochlear anatomy in one or both ears.
- Chronic ear infection in one or both ears.
- Previous cochlear implant experience.
- Disability which could interfere with the completion of the tests.
- Deafness caused by meningitis, otosclerosis or Cogans syndrome.
- Severely visually impaired
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL34845.041.10 |
| OMON | NL-OMON24087 |