Evaluation of Performance and Usability of N6 in the Paediatric Population

NCT01800929 | Unknown

• 1 other identifier: CAP5433
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Transplants and Implants; Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• speech recognition scores in quiet and noise between the two processors

  Nov 2012-June 2013

• Useability questionnaire on the different sound processing features

  Nov 2012-June 2013

• Subjective feedback on performance as well as patient preference between the 2 processors

  Nov 2012-June 2013

• Evaluate the usability of the two systems in a group of children, their carers and their teachers

  Nov 2012-June 2013

• Clinical recommendations for fitting paediatric recipients with the new processor

  Nov 2012-June 2013

Study Arms (2)

N6

EXPERIMENTAL

The N6 system comprises an investigational sound processor, remote assistant and fitting software

Device: N6

N5

ACTIVE COMPARATOR

The current commercially-available cochlear implant system Performance of N5 will be compared to performance with N6 using a within-subject design.

Device: N6

Interventions

N6 DEVICE

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

N5; N6

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cochlear, Asia Pacific: lead
• The HEARing Co-operative Research Centre, Melbourne: collaborator
• Melbourne Cochlear Implant Clinic, Melbourne: collaborator
• The Shepherd Centre, Sydney: collaborator
• Hear and Say Centre: collaborator
• The Hearing House, Auckland: collaborator

Study Sites (4)

The Shepherd Centre

Sydney, New South Wales, 2008, Australia

ACTIVE NOT RECRUITING

Hear and Say Centre

Brisbane, Queensland, 4066, Australia

RECRUITING

Melbourne Cochlear Implant Clinic

Melbourne, Victoria, 3002, Australia

RECRUITING

The Hearing House

Auckland, New Zealand

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Robert Cowan, PhD

CONTACT

+61294286555; r.cowan@unimelb.edu.au

Valerie Looi, PhD

CONTACT

+61296115896; vlooi@cochlear.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: February 28, 2013
• Study Start: November 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 1, 2013

Record last verified: 2013-02

Locations

AU (3); NZ (1)