Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
25 participants
INTERVENTIONAL
2022-05-30
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Electric Pace-pitched Hearing Achieves Natural Tonotopy
NCT03892941
Societal Merit of Intervention on Hearing Loss Evaluation
NCT05525221
Administration Method of Cognitive Screening in Older Individuals With Hearing Loss
NCT03402932
At-home Auditory Training Clinical Trial
NCT01950013
A Study Protocol for the Validation of UAud in a Clinical Setting.
NCT05043207
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fitting and Training Intervention
All participants will undergo the full set of diagnostic visits and both Fitting and Training interventions.
The Fitting Intervention is an adjustment of their processors' MAPs based on their error pattern.
The Training Intervention is a personalized training via an app focusing on their most frequent errors.
Tone Audiometry
Evaluation of the participants' audiometrical thresholds
Spectrotemporal Assessment
Evaluation of the participants' promptness in detecting a modulation of a harmonic complex
Phoneme and Speech Perception
Evaluation of the participants' understanding of phonemes and short words, both in quiet and in noise
Digit Triplet Test
Evaluation of the participants' ability to discern speech in noise
Personalized fitting
Adjustment of the parameters of the participants' cochlear implants aimed at improving their speech perception
Personalized training
Self-administered training exercises focused on the speech components the participants are experiencing difficulties into
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tone Audiometry
Evaluation of the participants' audiometrical thresholds
Spectrotemporal Assessment
Evaluation of the participants' promptness in detecting a modulation of a harmonic complex
Phoneme and Speech Perception
Evaluation of the participants' understanding of phonemes and short words, both in quiet and in noise
Digit Triplet Test
Evaluation of the participants' ability to discern speech in noise
Personalized fitting
Adjustment of the parameters of the participants' cochlear implants aimed at improving their speech perception
Personalized training
Self-administered training exercises focused on the speech components the participants are experiencing difficulties into
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cochlear
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wendy Huinck, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radboud university medical center
Nijmegen, Gelderland, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-13495
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.