Evaluation of Performance and Usability of N6 in the Paediatric Population
NCT ID: NCT01800929
Last Updated: 2013-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2012-11-30
2013-06-30
Brief Summary
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Detailed Description
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Outcome measures:
* City University of New York (CUNY) Sentence Test in quiet and noise
* Consonant-Nucleus-Consonant (CNC) words in quiet
* in-house designed Usability questionnaires of the N6 system (information to be used internally)
* PEACH, TEACH and SELF questionnaires - developed by Ching \& Hill (2007). PEACH - The Parents' Evaluation of Aural/oral performance of Children TEACH - The Teachers' Evaluation of Aural/oral performance of Children for teachers SELF - The Child's Self evaluation of aural/oral performance.
Speech perception tests will be administered at baseline, then again three times, two weeks apart with the N6 processor - i.e. week 0, week 2, week 4 \& week 6. Total time: 2 months.
Questionnaires will also be given at the same time points, to get baseline information, as well as N6 information
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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N6
The N6 system comprises an investigational sound processor, remote assistant and fitting software
N6
Children with N5 will be upgraded to the N6 for a period of up to 2 months to evaluate.
N5
The current commercially-available cochlear implant system Performance of N5 will be compared to performance with N6 using a within-subject design.
N6
Children with N5 will be upgraded to the N6 for a period of up to 2 months to evaluate.
Interventions
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N6
Children with N5 will be upgraded to the N6 for a period of up to 2 months to evaluate.
Eligibility Criteria
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Inclusion Criteria
* Minimum speech perception ability in noise of 30% at +10 decibels (dB) signal-to-noise ratio (SNR).
* Minimum of 2 years cochlear implant (CI) experience, including at least 6 months experience with their current processor
* Excellent verbal reporters
* Excellent record of attending clinical appointments.
* Attend a regular school,
* English 1st language.
* Excellent record of compliance with habilitation tasks.
Exclusion Criteria
* Inability to attend study appointments.
5 Years
14 Years
ALL
Yes
Sponsors
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The HEARing Co-operative Research Centre, Melbourne
UNKNOWN
Melbourne Cochlear Implant Clinic, Melbourne
UNKNOWN
The Shepherd Centre, Sydney
UNKNOWN
Hear and Say Centre
OTHER
The Hearing House, Auckland
UNKNOWN
Cochlear, Asia Pacific
OTHER
Responsible Party
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Locations
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The Shepherd Centre
Sydney, New South Wales, Australia
Hear and Say Centre
Brisbane, Queensland, Australia
Melbourne Cochlear Implant Clinic
Melbourne, Victoria, Australia
The Hearing House
Auckland, , New Zealand
Countries
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Central Contacts
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Facility Contacts
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Michelle Moran, M Aud
Role: primary
Alex Rousset, M Aud
Role: backup
Other Identifiers
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CAP5433
Identifier Type: -
Identifier Source: org_study_id
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