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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01800929
Other study ID # CAP5433
Secondary ID
Status Recruiting
Phase N/A
First received August 27, 2012
Last updated February 28, 2013
Start date November 2012
Est. completion date June 2013

Study information

Verified date February 2013
Source Cochlear, Asia Pacific
Contact Robert Cowan, PhD
Phone +61294286555
Email r.cowan@unimelb.edu.au
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 14 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
N6
Children with N5 will be upgraded to the N6 for a period of up to 2 months to evaluate.

Locations

Country Name City State
Australia Hear and Say Centre Brisbane Queensland
Australia Melbourne Cochlear Implant Clinic Melbourne Victoria
Australia The Shepherd Centre Sydney New South Wales
New Zealand The Hearing House Auckland

Sponsors (6)

Lead Sponsor Collaborator
Cochlear, Asia Pacific Hear and Say, Brisbane, Melbourne Cochlear Implant Clinic, Melbourne, The HEARing Co-operative Research Centre, Melbourne, The Hearing House, Auckland, The Shepherd Centre, Sydney

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Group usability performance data for N6 versus N5 The investigational sound processor, remote assistant and fitting software will be compared to the existing implant system on measures of speech perception and usability in a take-home study. Nov 2012-June 2013 No
Secondary speech recognition scores in quiet and noise between the two processors The CUNY sentences and CNC word lists will be administered in quiet and noise. Nov 2012-June 2013 No
Secondary Useability questionnaire on the different sound processing features An in house questionnaire has been developed where the parent is asked to rank various features of the device, and its usability on a 5-point Likert Scale Nov 2012-June 2013 No
Secondary Subjective feedback on performance as well as patient preference between the 2 processors The PEACH, TEACH and SELF (Ching & Hill, 2007) will be used to collect this information from the parent, teacher and child. These questionnaires have been used in many previous studies.
In addition, any verbal feedback provided by recipients will be noted on CRFs.
Nov 2012-June 2013 No
Secondary Evaluate the usability of the two systems in a group of children, their carers and their teachers The information from the above questionnaires will be used to collectively compare the usability of the child's current processor and the N6 processor. Nov 2012-June 2013 No
Secondary Clinical recommendations for fitting paediatric recipients with the new processor Nov 2012-June 2013 No
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