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NCT06173687: DICE

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

Completed NA Results posted Last updated 3 December 2025
What this trial tests

NA trial testing The impedance measurement task using the Mobile Research App (MRA) in Hearing Loss in 51 participants. Completed in 24 October 2024.

Timeline
29 January 2024
Primary endpoint
24 October 2024
24 October 2024

Quick facts

Lead sponsorCochlear
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment51
Start date29 January 2024
Primary completion24 October 2024
Estimated completion24 October 2024
Sites4 locations across Belgium, Sweden, Australia

Drugs / interventions tested

Conditions studied

Sponsor

Cochlear — full company profile →

Who can join

18 and older, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Impedance Measurements Primary · 8 Weeks

Median of the standard deviation in total electrode impedance (measured in kOhm, averaged across 22 electrode contacts) between days for 8 weeks.

GroupValue95% CI
All Participants0.360.27 – 0.67

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Participants
Serious: 3/51 (6%)
Deaths: 0/51

Serious adverse events (4 terms)

ReactionSystemAll Participants
TachycardiaCardiac disorders
Epileptic seizuresNervous system disorders
MyelomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)

Most-reported serious reactions: Tachycardia, Epileptic seizures, Myeloma, Breast cancer.

Data from ClinicalTrials.gov NCT06173687 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Hearing Loss

Currently open trials in the same condition.

Other Cochlear trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06173687.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing