Clinical trial NCT01800929: Evaluation of Performance and Usability of N6 in the Paediatric Population
Official title: Evaluation of Performance and Usability of N6 in the Paediatric Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transplants and Implants
Hearing Loss
Lead sponsor: Cochlear, Asia Pacific
Sponsor class: OTHER
Collaborators: name: The HEARing Co-operative Research Centre, Melbourne
name: Melbourne Cochlear Implant Clinic, Melbourne
name: The Shepherd Centre, Sydney
name: Hear and Say Centre
name: The Hearing House, Auckland
First posted: 2013-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the performance and usability of the N6 system in children with the N5 system.

Detailed description: This study will evaluate the user benefits of the N6 system in the paediatric population currently equipped with N5. The performance and usability of both systems will be evaluated and compared. The performance of the N6 is expected to be at least equivalent to the N5.

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

Eligibility criteria: Inclusion Criteria:

* Age 5-14 years, currently using N5
* 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:

* Cognitive impairment, or other significant impairment that would impact on their ability to undertake task requirements
* Inability to attend study appointments.

Primary outcomes:
measure: Group usability performance data for N6 versus N5
timeFrame: Nov 2012-June 2013
Secondary outcomes:
measure: speech recognition scores in quiet and noise between the two processors
timeFrame: Nov 2012-June 2013
measure: Useability questionnaire on the different sound processing features
timeFrame: Nov 2012-June 2013
measure: Subjective feedback on performance as well as patient preference between the 2 processors
timeFrame: Nov 2012-June 2013
measure: Evaluate the usability of the two systems in a group of children, their carers and their teachers
timeFrame: Nov 2012-June 2013
measure: Clinical recommendations for fitting paediatric recipients with the new processor
timeFrame: Nov 2012-June 2013
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: The Shepherd Centre
state: New South Wales
city: Brisbane
country: Australia
facility: Hear and Say Centre
state: Queensland
city: Melbourne
country: Australia
facility: Melbourne Cochlear Implant Clinic
state: Victoria
city: Auckland
country: New Zealand
facility: The Hearing House
Study officials:
References: