Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients (DUAL)

March 5, 2024 updated by: Cochlear

A Prospective, Single Centre, Single-blinded, Within-subject Investigation, on the Effect of Stimulation Parameter Changes, and Monopolar and Dual-electrode Mode Changes, on Speech Perception in Experienced Adult Cochlear Implant Recipients

This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

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 Contact

Study Locations

  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2109
        • Cochlear Macquarie
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI513, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI24RE(CS), CI422)
  • At least three months after activation of the cochlear implant.
  • Eighteen years or older at the time of consent.
  • User of 900Hz ACE (Advanced Combination Encoder) strategy MAP.
  • Score of 20% or more for CNC words presented at 60dBSPL with CI alone in the test ear.
  • Fluent speaker in English.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • One or more electrodes turned off in the MAP used regularly.
  • Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
  • 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.
  • Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors
Participants will receive four different MAPs to use during two take-home periods and will then complete hearing assessments using each MAP.
Device: Program using default MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Device: Program using low-power 1 (LP1) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Device: Program using low-power 2 (LP2) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Device: Program using low-power 3 (LP3) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paired difference in percentage CNC words correct between default and LP1 MAPs in quiet setting
Time Frame: week 4 and week 8
Speech perception in quiet will be measured using recorded CNC monosyllabic words at 60 dB SPL from S0 position to emulate conversational levels. The goal of speech perception assessment in quiet is to compare % words correct for each of the conditions.
week 4 and week 8
Paired difference in dB SRT (AuSTIN) between default and LP1 MAPs in noise
Time Frame: week 4 and week 8
Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the SNR for 50% speech intelligibility.
week 4 and week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paired difference in percentage CNC words correct between LP1 MAP and LP2 MAP in quiet setting
Time Frame: week 4 and week 8
Speech perception in quiet will be measured using recorded CNC monosyllabic words at 60 dB SPL from S0 position to emulate conversational levels. The goal of speech perception assessment in quiet is to compare % words correct for each of the conditions.
week 4 and week 8
Paired difference in dB SRT (AuSTIN) between LP1 and LP2 MAPs in noise
Time Frame: week 4 and week 8
Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the SNR for 50% speech intelligibility.
week 4 and week 8
Paired difference in percentage CNC words correct between LP1 and LP3 MAPs in quiet setting
Time Frame: week 4 and week 8
Speech perception in quiet will be measured using recorded CNC monosyllabic words at 60 dB SPL from S0 position to emulate conversational levels. The goal of speech perception assessment in quiet is to compare % words correct for each of the conditions.
week 4 and week 8

Collaborators and Investigators

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

Sponsor

Cochlear

Collaborators

Avania

Investigators

  • Principal Investigator: Esti Nel, 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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLTD5853

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

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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