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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06298396
Registration number
NCT06298396
Ethics application status
Date submitted
28/02/2024
Date registered
7/03/2024
Titles & IDs
Public title
Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients
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Scientific title
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
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Secondary ID [1]
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CLTD5853
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Universal Trial Number (UTN)
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Trial acronym
DUAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hearing Loss, Sensorineural
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Condition category
Condition code
Ear
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Deafness
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Program using default MAP
Treatment: Devices - Program using low-power 1 (LP1) MAP
Treatment: Devices - Program using low-power 2 (LP2) MAP
Treatment: Devices - Program using low-power 3 (LP3) MAP
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.
Treatment: Devices: Program using default MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Treatment: Devices: Program using low-power 1 (LP1) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Treatment: Devices: Program using low-power 2 (LP2) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Treatment: Devices: Program using low-power 3 (LP3) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Paired difference in percentage CNC words correct between default and LP1 MAPs in quiet setting
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Assessment method [1]
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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.
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Timepoint [1]
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week 4 and week 8
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Primary outcome [2]
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Paired difference in dB SRT (AuSTIN) between default and LP1 MAPs in noise
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Assessment method [2]
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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.
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Timepoint [2]
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week 4 and week 8
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Secondary outcome [1]
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Paired difference in percentage CNC words correct between LP1 MAP and LP2 MAP in quiet setting
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Assessment method [1]
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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.
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Timepoint [1]
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week 4 and week 8
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Secondary outcome [2]
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Paired difference in dB SRT (AuSTIN) between LP1 and LP2 MAPs in noise
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Assessment method [2]
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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.
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Timepoint [2]
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week 4 and week 8
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Secondary outcome [3]
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Paired difference in percentage CNC words correct between LP1 and LP3 MAPs in quiet setting
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Assessment method [3]
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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.
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Timepoint [3]
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week 4 and week 8
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/05/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2025
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Cochlear Macquarie - Macquarie Park
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Recruitment postcode(s) [1]
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2109 - Macquarie Park
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Cochlear
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Avania
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.
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Trial website
https://clinicaltrials.gov/study/NCT06298396
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Esti Nel
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Address
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Cochlear
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Niva Shrestha
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Address
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Country
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Phone
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+61296116177
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06298396