Evaluation of Performance and Usability of N6 in the Paediatric Population

February 28, 2013 updated by: Cochlear, Asia Pacific
The purpose of this study is to evaluate the performance and usability of the N6 system in children with the N5 system.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2008
        • Active, not recruiting
        • The Shepherd Centre
    • Queensland
      • Brisbane, Queensland, Australia, 4066
        • Recruiting
        • Hear and Say Centre
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Rachel Finbow, M Aud
        • Principal Investigator:
          • Jane McGovern, M Aud St
        • Sub-Investigator:
          • Trudie Dowell, M Aud
        • Sub-Investigator:
          • Beth Atkinson
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Melbourne Cochlear Implant Clinic
        • Contact:
          • Michelle Moran, M Aud
          • Phone Number: +61399298624
        • Contact:
          • Alex Rousset, M Aud
          • Phone Number: +61399298624
        • Principal Investigator:
          • Michelle Moran, M Aud
        • Principal Investigator:
          • Alex Rousset, M Aud
        • Principal Investigator:
          • Jaime Leigh, M Aud
  • New Zealand
      • Auckland, New Zealand
        • Recruiting
        • The Hearing House
        • Contact:
        • Contact:
        • Principal Investigator:
          • Leigh Martelli, M Aud
        • Sub-Investigator:
          • Clair Spence, M Aud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N6
The N6 system comprises an investigational sound processor, remote assistant and fitting software
Device: N6
Children with N5 will be upgraded to the N6 for a period of up to 2 months to evaluate.
Active Comparator: N5
The current commercially-available cochlear implant system Performance of N5 will be compared to performance with N6 using a within-subject design.
Device: N6
Children with N5 will be upgraded to the N6 for a period of up to 2 months to evaluate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Group usability performance data for N6 versus N5
Time Frame: Nov 2012-June 2013
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
speech recognition scores in quiet and noise between the two processors
Time Frame: Nov 2012-June 2013
The CUNY sentences and CNC word lists will be administered in quiet and noise.
Nov 2012-June 2013
Useability questionnaire on the different sound processing features
Time Frame: Nov 2012-June 2013
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
Subjective feedback on performance as well as patient preference between the 2 processors
Time Frame: Nov 2012-June 2013

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
Evaluate the usability of the two systems in a group of children, their carers and their teachers
Time Frame: Nov 2012-June 2013
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
Clinical recommendations for fitting paediatric recipients with the new processor
Time Frame: Nov 2012-June 2013
Nov 2012-June 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear, Asia Pacific

Collaborators

The HEARing Co-operative Research Centre, Melbourne
Melbourne Cochlear Implant Clinic, Melbourne
The Shepherd Centre, Sydney
Hear and Say Centre
The Hearing House, Auckland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

August 27, 2012

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Estimate)

March 1, 2013

Last Update Submitted That Met QC Criteria

February 28, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAP5433

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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