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Bilateral Cochlear Implantation in Adults (RCT).


- candidate number5444
- NTR NumberNTR1722
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mrt-2009
- Secondary IDsNL24990.018.08 METC AMC
- Public TitleBilateral Cochlear Implantation in Adults (RCT).
- Scientific TitleBilateral Cochlear Implantation Benefits in Adult Users of the HiRes(R) 90K Bionic Ear System.
- ACRONYMN/A
- hypothesisNormal-hearing listeners gain important benefits from having two ears. Users of a Bionic Ear achieve high levels of spoken word recognition when speech is presented in quiet. However they experience difficulty in the presence of competing sounds and are poor at identifying where sounds come from. These limitations may be overcome, to some degree, by providing an implant to both ears. This study will investigate bilateral versus unilateral benefit in adults who are implanted with two Bionic Ears either simultaneously or sequentially.
- Healt Condition(s) or Problem(s) studiedHearing loss
- Inclusion criteria1. Age 18-75;
2. Postlingual onset of hearing loss;
3. Severe Sensorineural hearing loss;
4. Duration of severe hearing loss <20 years;
5. Marginal hearing aid benefit with hearing aids;
6. Dutch language proficiency;
7. Willingness and ability to participate in all scheduled procedures outlined in the protocol;
8. General health allowing general anaesthesia for the potential implantation of two cochlear implants during a single surgery;
9. Patients covered by the Dutch health insurance;
10. Patients should agree to be implanted with cochlear implants from Advanced Bionics.
- Exclusion criteria1. Previous implant experience;
2. Disability which could interfere with the completion of the tests;
3. Abnormal cochlear anatomy in one or both ears;
4. Chronic ear infection in one or both ears.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2009
- planned closingdate8-sep-2017
- Target number of participants48
- InterventionsSimultaneous or sequential bilateral cochlear implantation.
- Primary outcomePerformance on the STAR2 hearing test.
- Secondary outcome1. Performance on the Standard Dutch phoneme test, the Speech intelligibility test with spatially separated sources and the Crescent of sound test;
2. Self-reported benefits in everyday listening situations assessed with the SSQ;
3. Quality-of-life questionnaire scores;
4. Tinnitus questionnaire results.
- Timepoints1. Preoperatively;
2. 1 year post (first) implantation;
3. 2 years post (first) implantation;
4. In sequential implantation group: 1 and 2 years after second implantation.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. Y.E. Smulders
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W. Grolman
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of ENT
- Funding
(Source(s) of Monetary or Material Support)
Advanced Bionics
- PublicationsN/A
- Brief summaryBrief summary:
This study will investigate bilateral versus unilateral benefit in adults who are implanted with two Bionic Ears either simultaneously or sequentially. The objective is to evaluate the degree of bilateral benefit gained from having a second implant. 48 Adult subjects with severe sensorineural hearing loss will be included in this Randomised Controlled Trial. Half of the group shall receive one implant at the beginning of the study and a second implant after a period of two years. The other half shall receive two cochlear implants simultaneously during one operation. Objective and subjective parameters will be measured during evaluation sessions pre-operatively, and 1 and 2 years after cochlear implantation.
- Main changes (audit trail)
- RECORD11-mrt-2009 - 4-nov-2017


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