1) Compare a group of bilateral users to a unilateral control group (between-subject design)2) Compare unilateral use to bilateral use after sequential implantation (within-subject design)3) Compare simultaneous bilateral implantation to sequential…
ID
Source
Brief title
Condition
- Hearing disorders
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluate the benefits adults obtain from bilateral versus unilateral cochlear
implant use.
Compare bilateral cochlear implant benefit after simultaneous versus sequential
implantation
Primary parameter:
Performance on hearing in noise test with sentences in Dutch (Objective).
Secondary outcome
Evaluate the benefits adults obtain from bilateral versus unilateral cochlear
implant use.
Compare bilateral cochlear implant benefit after simultaneous versus sequential
implantation
Secundary parameters:
Objective:
Performance on Standard Dutch phoneme test (NvA-list, Bosman), Performance on
Speech intelligibility with spatially separated sources, Performance on
Crescent of sound tests (Quentin Summerfield)
Subjective:
Self-reported benefits in everyday listening situations assessed with the
Speech, Spatial and Qualities Hearing Scale (SSQ),
Quality-of-life questionnaire scores, Tinnitus questionnaire scores.
Background summary
Based upon the advantages normal-hearing listeners gain from having two ears,
upon the fact that users of two implants demonstrate quantifiable improved
benefit over single-implant use, upon the need for studies in which the
methodology strongly control for biases such as in Randomised Controlled Trials
(RCTs), and upon preliminary data indicating that HiRes sound processing may
provide enhanced binaural benefit, this study will use an RCT to investigate
the benefits adults obtain from HiRes after simultaneous or sequential
bilateral implantation.
Study objective
1) Compare a group of bilateral users to a unilateral control group
(between-subject design)
2) Compare unilateral use to bilateral use after sequential implantation
(within-subject design)
3) Compare simultaneous bilateral implantation to sequential bilateral
implantation (between-subject design)
Study design
The study is a randomised controlled trial in which patients who fit within the
inclusion criteria and who accept to take part in the study are randomly
assigned to simultaneous or sequential bilateral implantation. Subjects
assigned to simultaneous bilateral implantation shall receive two implants at
the beginning of the study and shall be evaluated before surgery and after one
and two years bilateral implant use. The group assigned to sequential
implantation shall receive one implant at the beginning of the study, be
evaluated before the first surgery and one and two years thereafter. After two
years of unilateral use, they will receive a second implant, with which they
shall be evaluated after another one and two years of bilateral use.
Performances and self-reported benefits will be measured for all subjects.
The subjective outcomes will be compared to self-reported benefits (quality of
life questionnaires) of 20 unrandomised subjects who will undergo regular
unilateral cochlear implantation. The extra control group will only be
recruited once the first 48 patients have been selected.
Intervention
Cochlear implant surgery
Study burden and risks
Compared to routine clinical practice, the study requires that the subjects
undergo a second cochlear implantation either in an extended surgery (about an
added 50 % surgical time) or in an additional second surgery after 2 years.
This carries the usual risks associated with surgery and a slightly longer
anaesthetic exposure. The clinical management will otherwise be unaffected
besides appointment times being longer to ensure that both implants are
optimally working.
Note: In the AMC we normally use a rapid surgical technique which in total
reduces the total surgical time, compared to the classic procedure, with about
50%.
2 Breaks House, Mill Court, Great Shelford
Cambridge CB22 5LD
GB
2 Breaks House, Mill Court, Great Shelford
Cambridge CB22 5LD
GB
Listed location countries
Age
Inclusion criteria
Adult patients with bilateral sensorineural hearing loss of a severe or greater degree and with postlingual onset
Exclusion criteria
Previous cochlear implant experience, abnormal cochlear anatomy, non-fluent in Dutch, disabilities which could interfere with the tests.
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 | NL24990.018.08 |