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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06173687




Registration number
NCT06173687
Ethics application status
Date submitted
19/10/2023
Date registered
18/12/2023
Date last updated
25/11/2024

Titles & IDs
Public title
Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons with a Cochlear Implant
Scientific title
Feasibility, Prospective, Multicentric, Cross-sectional Investigation to Characterize Daily Impedance Fluctuations and Satisfaction in Challenging Listening Environments in Experienced Adult CI Recipients Using the Mobile Research App (MRA)
Secondary ID [1] 0 0
AI5846
Universal Trial Number (UTN)
Trial acronym
DICE
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 - The impedance measurement task using the Mobile Research App (MRA)

Experimental: All participants -


Treatment: Devices: The impedance measurement task using the Mobile Research App (MRA)
Characterisation of impedance and real-world monitoring of hearing difficulty in range of listening environments.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Impedance Measurements
Timepoint [1] 0 0
8 Weeks

Eligibility
Key inclusion criteria
* Aged 18 years or older (no upper age limit).
* Implanted with CIC4-based implant with a Contour Advance, Slim Straight or Slim Modiolar electrode array with at least 6 months experience.
* Candidate is a fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
* 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
* Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (digital literacy check).
* A failed ECE1 or ECE2 (i.e. flagged, open circuit or short circuit)
* Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
* 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
Other
Allocation to intervention
Not applicable
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/10/2024
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Cochlear Macquarie - Sydney
Recruitment hospital [2] 0 0
HEARnet - Carlton
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment postcode(s) [2] 0 0
3052 - Carlton
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Sweden
State/province [2] 0 0
Västergötland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cochlear
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this, reflecting situations the subjects encounter during their daily life outside of the clinic. Improving the monitoring of both aspects may lead to improvements in monitoring and personalising the fitting to optimise hearing outcomes for persons with a cochlear implant.
Trial website
https://clinicaltrials.gov/study/NCT06173687
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Taike Bruyneel
Address 0 0
Country 0 0
Phone 0 0
003216795564
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06173687