Sound Processing. ( A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Sound Processing in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation)

August 29, 2023 updated by: Cochlear

A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Sound Processing in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation.

This is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a CE approved Nucleus cochlear implant.

Subjects older than 5 years will be included. Subjects will be screened and up to 120 eligible subjects will be recruited in the clinical investigation.

Subjects will attend scheduled study visits over a period up to 5 years in different sub-studies as described in the sub-study documentation.

A clinical setting can consist of therapeutic elements and evaluations. Subjects will be assessed with the commercially available Nucleus sound processor or via the xPC, NIC, etc. if required. Acute testing will be done where possible. Take home use will be applied when learning effects may play a significant role and to evaluate the acceptance of the new or improved sound coding algorithm or signal processing, in as many listening environments as possible. The subject might also be asked to complete questionnaires, to perform at-home tests etc. during this take home use and/or at the clinical visits. The time for a clinical visit will be limited to a maximum of 4 hours. The time in between clinical visits will vary with typical spacing of between 0 (acute) to 4 weeks.

The goals of this umbrella investigation are to measure hearing outcomes to assess performance and/or to achieve higher convenience for implant users and hearing care professionals. The outcomes of the study will guide Cochlear to select features for inclusion in future Nucleus cochlear implant systems and/or future models of care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

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
      • East Melbourne, Australia, 3002
        • Cochlear Ltd. Melbourne
    • Victoria
      • Carlton, Victoria, Australia, 3052
        • HEARnet Clinical Studies
  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint-Jan Brugge-Oostende AV
      • Mechelen, Belgium, 2800
        • Cochlear Technology Centre Belgium
      • Wilrijk, Belgium, 2610
        • Sint-Augustinus Antwerpen

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 and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding.
  • Paediatrics: Older than 5 years and <18 years when entering the study. (Belgium only) or
  • Adults: ≥18 years when entering the study (Belgium and Australia).
  • Subject/legally designated representative is fluent speaker in the language used for assessments.
  • Willing and able to provide written informed consent (for paediatric populations this criterion applies to the parent/ legally designated representative).

Exclusion Criteria:

  • Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
  • Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
  • Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
  • Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
  • Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OPAL Sound Processing Strategy
OPAL Sound Processing Strategy with programming being performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool).
Device: OPAL Sound Processing Strategy.
OPAL Sound Processing Strategy. OPAL sound processing strategy designed to improve perception of fundamental frequency (F0) as cue to lexical tone in tonal languages and to pitch in music. This research strategy will be implemented in the Nucleus 6 CP900 sound processors. The programming will be performed by the investigational software Cochlear Device Interface Tool (CDI Tool). Investigational firmware will be written on a commercially available N6 sound processor sound processor.
Device: Cochlear Device Interface Tool
For all strategies, programming will be performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). Investigational software will be used to stream stimulation sequences to a commercially available N6 sound processor using the Cochlear NIC4.1 interface.
Other Names:
  • CDI Tool
Experimental: OPAL-EM
OPAL-Enhanced Modulation with programming being performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool).
Device: Cochlear Device Interface Tool
For all strategies, programming will be performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). Investigational software will be used to stream stimulation sequences to a commercially available N6 sound processor using the Cochlear NIC4.1 interface.
Other Names:
  • CDI Tool
Device: OPAL-EM
OPAL-EM (Enhanced Modulation) is a version of OPAL that improves temporal accuracy in the coding of F0 amplitude-modulation in the stimulus envelope. It is specifically designed to address the need for use of low stimulation rates (i.e., lower than the recommended OPAL rate of around 1200 pps/ch) but it is also expected to provided improvements for all stimulation rates by virtue of the improved temporal accuracy it provides.
Other Names:
  • OPAL Enhanced Modulation
Experimental: SPACE
Spread Precompensation Advanced Combination Encoder (SPACE) with programming being performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool).
Device: Cochlear Device Interface Tool
For all strategies, programming will be performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). Investigational software will be used to stream stimulation sequences to a commercially available N6 sound processor using the Cochlear NIC4.1 interface.
Other Names:
  • CDI Tool
Device: SPACE
SPACE (Spread Precompensation Advanced Combination Encoder) is a sound coding strategy that is intended to improve spectral resolution, and hence hypothesised to improve cochlear implant (CI) speech understanding in noise. It is an alternative to the ACE sound coding strategy. It has been implemented on the Nucleus 7 CP1000 sound processor for CIC4-based implants.
Other Names:
  • Spread Precompensation Advanced Combination Encoder
Experimental: FAST
Fundamental Asynchronous Stimulus Timing (FAST) with programming being performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool).
Device: Cochlear Device Interface Tool
For all strategies, programming will be performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). Investigational software will be used to stream stimulation sequences to a commercially available N6 sound processor using the Cochlear NIC4.1 interface.
Other Names:
  • CDI Tool
Device: FAST
FAST (Fundamental Asynchronous Stimulus Timing) is a low- and variable-rate coding strategy that has been shown to be power efficient and significantly increase sensitivity to ITD cues in bilateral subjects. It also explicitly codes low F0s as the rate of stimulation and may have tone and music benefits. It has been implemented on the Nucleus 5 CP800 sound processor for CIC4-based implants.
Other Names:
  • Fundamental Asynchronous Stimulus Timing
Experimental: OPAL-SPACE
OPAL-SPACE (combined OPAL and SPACE strategy) with programming being performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool).
Device: Cochlear Device Interface Tool
For all strategies, programming will be performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). Investigational software will be used to stream stimulation sequences to a commercially available N6 sound processor using the Cochlear NIC4.1 interface.
Other Names:
  • CDI Tool
Device: OPAL-SPACE
OPAL-SPACE (combined OPAL and SPACE strategy) aims to preserve as many of the significant features encoded by both OPAL and SPACE strategies individually. Since SPACE codes spectral envelope information, while OPAL codes temporal periodicity information, it is reasonable to suggest that both coding techniques can be combined to improve perception additively.
Experimental: FAST-OPAL
FAST-OPAL (combined FAST and OPAL strategy) with programming being performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool).
Device: Cochlear Device Interface Tool
For all strategies, programming will be performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). Investigational software will be used to stream stimulation sequences to a commercially available N6 sound processor using the Cochlear NIC4.1 interface.
Other Names:
  • CDI Tool
Device: FAST-OPAL
FAST-OPAL (combined FAST and OPAL strategy) strategy was developed to improve FAST strategy performance in noisy environments. The processing techniques employed by FAST-OPAL retain the sparse, yet temporally precise coding of temporal envelope information, while improving coding of that information in noise and coding of relative across-channel intensity in noise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monosyllabic word in quiet scores .
Time Frame: One Day
Monosyllabic word in quiet scores(for conventional Advanced Combination Encoders and new sound coding strategy). Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome
One Day

Collaborators and Investigators

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

Sponsor

Cochlear

Collaborators

Avania
Trium Clinical Consulting

Investigators

  • Study Director: Komal Arora, Cochlear

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 (Actual)

January 22, 2020

Primary Completion (Actual)

March 17, 2023

Study Completion (Actual)

March 17, 2023

Study Registration Dates

First Submitted

June 27, 2022

First Submitted That Met QC Criteria

July 24, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI5762

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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