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Parametric cochlear implant map adjustment by implant recipients.


- candidate number1603
- NTR NumberNTR492
- ISRCTNISRCTN wordt niet meer aagevraagd
- Date ISRCTN created
- date ISRCTN requested18-nov-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleParametric cochlear implant map adjustment by implant recipients.
- Scientific TitleParametric cochlear implant map adjustment by implant recipients.
- ACRONYMPCIMAR
- hypothesisSpeech understanding with a speech processor fitted using the parametric fitting procedure and the recipient's own fine-tuning is as good as with a conventional fitting. The parametric fitting is more patient friendly and less time-consuming.
- Healt Condition(s) or Problem(s) studiedCochlear implant , Deafness
- Inclusion criteriaAdult cochlear implant (Nucleus 24R) receivers with 3-9 months experience with their implant.
- Exclusion criteriaInability to comply with the study follow-up, failure to obtain written consent, speech understanding too poor to perform the speech perception tests.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 18-dec-2003
- planned closingdate1-dec-2006
- Target number of participants20
- InterventionsTemporary use of a newly designed speech processor. Twenty cochlear implant patients receive an experimental speech processor, with which they can manually adjust the parameters 'shift' and 'tilt' of the C levels.
For the first 3 weeks they get an ECAP-based fitting in the new processor, without the possibility to make adjustments.
Speech perception tests are performed with the conventional and the ECAP-based fitting.
The last 3 weeks patients can adjust their fitting. This period is followed by speech perception tests with the non-adjusted and the adjusted ECAP-based fitting.
- Primary outcomeSpeech perception scores after recipients tried to optimize their own maps in combination with subjective questionnaire and log of button presses.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESDr. K. Willeboer
- CONTACT for SCIENTIFIC QUERIESDr. G.A. Zanten, van
- Sponsor/Initiator University Medical Center Utrecht (UMCU), AZU
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsN/A
- Brief summaryIn 20 adult cochlear implant recipients we measure speech perfomance using the parametric fitting procedure and the recipient's own adjustment in a newly designed speech processor and compare it with the parametric fitting without adjustments.
- Main changes (audit trail)
- RECORD12-sep-2005 - 14-sep-2009


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