Evaluation of Performance and Usability of N6 in the Paediatric Population

Hearing Loss Clinical Trial

Official title:

Evaluation of Performance and Usability of N6 in the Paediatric Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01800929
• Other study ID #: CAP5433
• 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

• Hearing Loss
• Transplants and Implants

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