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

Hearing Loss Clinical Trial

— DICE  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173687
• Other study ID #: AI5846
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Cochlear
• Contact: Taike Bruyneel
• Phone: 003216795564
• Email: tbruyneel[@]cochlear.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a feasibility, prospective, multi-country, multi-centre, cross-sectional interventional clinical investigation in adults with a CE labelled cochlear implant.

No Randomisation nor blinding to avoid bias is applicable in this study since there is no comparator.

Subjects will attend two scheduled study visits over a two-month study period. At and in between study visits, subjects will undergo hearing assessments and safety monitoring. The subjects will perform daily impedance test tasks and complete a questionnaire in order to obtain the first primary endpoint, i.e. characterization of Daily Impedance Fluctuations.

Furthermore, the subjects will do EMA tasks to obtain the secondary objectives to capture daily-life, real-world listening environments and challenging listening environments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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)

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Australia	HEARnet	Carlton	Victoria
Australia	Cochlear Macquarie	Sydney	New South Wales
Belgium	ENT Department, Sint-Augutinus Antwerp	Wilrijk	Antwerp
Sweden	Cochlear Bone Anchored Solutions AB (CBAS)	Mölnlycke	Västergötland

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Countries where clinical trial is conducted

Australia,  Belgium,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impedance Measurements	Variance in mean electrode impedance (measured in kohm, averaged across 22 electrode contacts) per day for 8 weeks.	8 Weeks