Clinical trial NCT05307952: Auditory Diagnostics and Error-based Treatment
Official title: Auditory Diagnostics and Error-based Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deafness, Bilateral
Deafness Neurosensory
Deafness Permanent
Keywords: Cochlear Implant
Speech Perception
Hearing
Speech
Prosthesis Fitting
Rehabilitation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Cochlear
First posted: 2022-04-01
Enrollment: 25
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: The main objective of this study is to assess the effectiveness of an integrated program of fitting and training interventions aimed at reducing unexpected variability and addressing the specific error patterns of each recipient.

The participants will undergo 1 visit lasting approximately 2 hours at the Radboud university medical center's ENT department, where they will undergo a series of diagnostic tests. Some of the participants will also be asked to self-administer additional tests using a Windows tablet.

Based on the outcomes of speech recognition tests in quiet at the first visit, the participants will be called for follow-up interventions concerning both the fitting of their CI and personalized auditory training based on their personal error patterns. These interventions will take place over the course of approximately 5 months and will be made up of three follow-up visits and a period of self-administered training through a mobile application on a tablet.

One final follow-up visit will check whether any changes from the interventions are retained after four weeks.


Eligibility criteria: Inclusion Criteria:

* Adult (over 18 years old at the time of inclusion )
* Post-lingually deafened (the subject had a good mastery of spoken language before onset of deafness)
* Native Dutch speaker
* Implanted, either unilaterally or bilaterally, with a Cochlear Implant manufactured by Cochlear Ltd (i.e., a Nucleus ® implant).
* Implanted with one of the following implants: CI422, CI512, CI522, CI532, CI24M, CI24R, CI24RE.
* Implanted for at least 12 months.

Exclusion Criteria:

* Known abnormally formed cochlea
* Known pre-implantation ossification of the cochlea
* Severe cognitive disorders affecting their ability to understand spoken language
* Intense facial nerve stimulation
* Unaddressed electrode tip foldover
* More than 4 electrodes deactivated because of malfunction (open/short circuit) or lack of response
* Additional illnesses or handicaps that could impact ability to participate in study, at the clinician's discretion.

Primary outcomes:
measure: Change in Percent Speech Recognition
timeFrame: Weeks 1, 10, 14, 18
Secondary outcomes:
measure: Change in Distance-based Accuracy Score
timeFrame: Weeks 1, 10, 14, 18
measure: Change in Error Dispersion
timeFrame: Weeks 1, 10, 14, 18
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Wendy Huinck, PhD
role: PRINCIPAL_INVESTIGATOR
References: