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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06298396




Registration number
NCT06298396
Ethics application status
Date submitted
28/02/2024
Date registered
7/03/2024
Date last updated
30/05/2024

Titles & IDs
Public title
Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients
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
Secondary ID [1] 0 0
CLTD5853
Universal Trial Number (UTN)
Trial acronym
DUAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss, Sensorineural 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Paired difference in percentage CNC words correct between default and LP1 MAPs in quiet setting
Timepoint [1] 0 0
week 4 and week 8
Primary outcome [2] 0 0
Paired difference in dB SRT (AuSTIN) between default and LP1 MAPs in noise
Timepoint [2] 0 0
week 4 and week 8
Secondary outcome [1] 0 0
Paired difference in percentage CNC words correct between LP1 MAP and LP2 MAP in quiet setting
Timepoint [1] 0 0
week 4 and week 8
Secondary outcome [2] 0 0
Paired difference in dB SRT (AuSTIN) between LP1 and LP2 MAPs in noise
Timepoint [2] 0 0
week 4 and week 8
Secondary outcome [3] 0 0
Paired difference in percentage CNC words correct between LP1 and LP3 MAPs in quiet setting
Timepoint [3] 0 0
week 4 and week 8

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Cochlear Macquarie - Macquarie Park
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cochlear
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Avania
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06298396
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Esti Nel
Address 0 0
Cochlear
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Niva Shrestha
Address 0 0
Country 0 0
Phone 0 0
+61296116177
Fax 0 0
Email 0 0
nshrestha@cochlear.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06298396