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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05476328




Registration number
NCT05476328
Ethics application status
Date submitted
27/06/2022
Date registered
27/07/2022
Date last updated
31/08/2023

Titles & IDs
Public title
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)
Scientific title
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.
Secondary ID [1] 0 0
AI5762
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - OPAL Sound Processing Strategy.
Treatment: Devices - OPAL-EM
Treatment: Devices - SPACE
Treatment: Devices - FAST
Treatment: Devices - OPAL-SPACE
Treatment: Devices - FAST-OPAL
Treatment: Devices - Cochlear Device Interface Tool

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).

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).

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).

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).

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).

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).


Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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.

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

Outcomes
Primary outcome [1] 0 0
Monosyllabic word in quiet scores .
Timepoint [1] 0 0
One Day

Eligibility
Key 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).
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
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
Other
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/03/2023
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
HEARnet Clinical Studies - Carlton
Recruitment hospital [2] 0 0
Cochlear Ltd. Melbourne - East Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Carlton
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brugge
Country [2] 0 0
Belgium
State/province [2] 0 0
Mechelen
Country [3] 0 0
Belgium
State/province [3] 0 0
Wilrijk

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
Trium Clinical Consulting
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Avania
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05476328
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Komal Arora
Address 0 0
Cochlear
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05476328