Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experience… (NCT06298396) | Clinical Trial Compass
CompletedNot Applicable
Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients
Australia20 participantsStarted 2024-05-27
Plain-language summary
This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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).
What they're measuring
1
Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet
Timeframe: 10 participants completed this test at Week 4, and 10 participants completed this at week 8
2
Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise
Timeframe: 10 participants completed the test at Week 4, 10 participants completed the test at Week 8