Clinical trial NCT06298396: Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients
Official title: A Prospective, Single Centre, Single-blinded, Within-subject Investigation, on the Effect of Stimulation Parameter Changes, and Monopolar and Dual-electrode Mode Changes, on Speech Perception in Experienced Adult Cochlear Implant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Keywords: Cochlear implant
Sensorineural hearing loss
Programming
Speech perception
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2024-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.


Eligibility criteria: 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).

Primary outcomes:
measure: Paired difference in percentage CNC words correct between default and LP1 MAPs in quiet setting
timeFrame: week 4 and week 8
measure: Paired difference in dB SRT (AuSTIN) between default and LP1 MAPs in noise
timeFrame: week 4 and week 8
Secondary outcomes:
measure: Paired difference in percentage CNC words correct between LP1 MAP and LP2 MAP in quiet setting
timeFrame: week 4 and week 8
measure: Paired difference in dB SRT (AuSTIN) between LP1 and LP2 MAPs in noise
timeFrame: week 4 and week 8
measure: Paired difference in percentage CNC words correct between LP1 and LP3 MAPs in quiet setting
timeFrame: week 4 and week 8
Other outcomes:
Locations:
city: Macquarie Park
country: Australia
facility: Cochlear Macquarie
state: New South Wales
Study officials:
affiliation: Cochlear
name: Esti Nel
role: PRINCIPAL_INVESTIGATOR
References: